The Cleft Palate–Craniofacial Journal 52(4) pp. 447–451 July 2015 Ó Copyright 2015 American Cleft Palate–Craniofacial Association
ORIGINAL ARTICLE Clinical Factors Affecting Length of Stay After 100 Consecutive Cases of Primary Cleft Lip Repair Albert K. Oh, M.D., Keshav Magge, M.D., Tina M. Sauerhammer, M.D., Jacqueline Kim, Mahlet Atnafu, Michael J. Boyajian, M.D., Gary F. Rogers, M.D., J.D., M.B.A. Objective: To analyze the hospital course of 100 consecutive infants after primary cleft lip repair (PCLR) and identify factors related to length of stay (LOS). Design: Retrospective analysis of 100 consecutive infants who were routinely admitted after PCLR. Setting: Tertiary care center. Patients: One hundred consecutive infants undergoing PCLR. Demographic and perioperative data were collected and analyzed. Main Outcome Measure: LOS, planned before data collection. Results: Male:female ratio was 65:35. Seventy-two infants had unilateral cleft lip; syndromic association was documented in 15 patients. Mean age and weight at PCLR were 5.6 6 4.0 months and 6.7 6 1.3 kg, respectively. Mean duration of surgery was 2.5 6 0.9 hours, and mean duration of general anesthesia was 3.4 6 0.9 hours. A total of 3.3 6 1.5 mL of intraoperative local anesthetic was used per patient. Intravenous fluids were necessary after transfer from the postanesthesia care unit to the general ward in 98% of patients. Almost half (44%) of all patients received intravenous morphine 23 hours or more after hospital admission. Mean LOS was 35.8 6 13.9 hours. No association was identified between patient demographic factors and LOS. Multivariate linear regression models identified significant positive correlation between LOS and duration of general anesthesia (P ¼ .002). Greater volume of postoperative oral intake (P ¼ .000) and higher acetaminophen dosage on the floor (P ¼ .000) correlated with decreased LOS. Conclusions: This study identifies perioperative factors associated with LOS. Our findings question the safety of routine outpatient or short-stay observation after PCLR. KEY WORDS:
cleft lip repair, postoperative admission, length of stay
The cost of health care in the United States is the highest in the world; national health expenditures totaled $2.5 trillion or 17.6% of the nation’s gross domestic product in 2009. That same year, President Barack Obama (2009) stated that, ‘‘by a wide margin, the biggest threat to our nation’s balance sheet is the skyrocketing cost of health care.’’ Providing safe and efficacious care with the least waste of resources should be the goal of health policy officials all over the world. Nevertheless, despite all efforts,
the cost of health care in the United States continues to climb at an exponential rate (Pastores et al., 2012). The push to reduce health care expenses has led many medical stakeholders to challenge traditional practices and standards of care. One of the most rigidly scrutinized areas is the need for inpatient hospitalization. Although it is economically intuitive that reducing the amount and intensity of patient monitoring will reduce costs, such objectives must be carefully balanced against the human and economic cost of a possible increase in morbidity and mortality. This tension has been felt in nearly every area of medicine; in the subspecialty of pediatric plastic surgery, one of the most contentiously debated issues is whether admission after primary cleft lip repair (PCLR) is necessary. Cleft lip with or without cleft palate is the most common craniofacial malformation; it affects 1 in 940 live births and results in an estimated 4,437 annual cases (Centers for Disease Control and Prevention, 2012). PCLR is typically performed within the first several months of life, during a period of relative high risk for postoperative airway compromise and dehydration. In the early 1990s, Lees
Dr. Oh is Assistant Professor, Dr. Magge is Fellow, Dr. Sauerhammer is Assistant Professor, Ms. Kim is undergraduate student, Ms. Atnafu is undergraduate student, Dr. Boyajian is Assistant Professor, and Dr. Rogers is Associate Professor, Division of Plastic and Reconstructive Surgery, Children’s National Medical Center, George Washington University, Washington, D.C. Presented at the 12th International Congress on Cleft Lip/Palate and Related Craniofacial Anomalies, Orlando, Florida, May 7, 2013. Submitted January 2014; Accepted May 2014. Address correspondence to: Dr. Albert K. Oh, Division of Plastic and Reconstructive Surgery, Children’s National Medical Center, 111 Michigan Avenue, NW, Washington, D.C. 20010. E-mail aoh@ childrensnational.org. DOI: 10.1597/14-006 447
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TABLE 1
Demographics of the Study Group
TABLE 2
Intraoperative Factors
Characteristics
Mean (6SD)
Boys:girls Mean (6SD) age (months) Mean (6SD) weight (kg) Diagnosis Unilateral complete cleft lip and/or palate Unilateral incomplete cleft lip and/or palate Bilateral complete cleft lip and/or palate Bilateral incomplete cleft lip and/or palate Syndromic:isolated
65:35 5.5 6 3.9 6.7 6 1.3 43 29 17 11 85:15
and Pigott (1992) demonstrated that admission before cleft lip/palate repair did not significantly improve outcomes. The results of this study and others in the early 1990s (Canady et al., 1994; Eaton et al., 1994) led to the discontinuation of routine admission before elective cleft lip or palatal procedures. In the next decade, as astutely predicted by Lewis (1994), investigators began to question the need for admission after cleft lip and cleft palatal repair. Several retrospective reports (Kim and Rothkopf, 1999; Cronin et al., 2001; Rosen et al., 2003; Saha et al., 2005; AlThunyan 2009; Ugburo et al., 2009) in relatively small number of patients with various forms of cleft lip/palate seem to demonstrate the apparent safety of ambulatory or short-stay repair of these anomalies. Thus, routine inpatient admission after PCLR may be unnecessary. The policy at our institution has been to routinely admit patients undergoing cleft lip/palate procedures on the day of surgical repair, anticipating a 1- or 2-day postoperative admission for intravenous (IV) hydration and pain control. In light of the reports outlined earlier, we reviewed the perioperative course of 100 consecutive infants undergoing PCLR to determine if these patients could have potentially been managed in a short-stay observational or outpatient status and to identify operative and postoperative factors that might predict the need for postoperative admission. PATIENTS
AND
METHODS
After obtaining institutional review board approval, the authors reviewed 100 consecutive infants undergoing PCLR from January 2008 to April 2012. A definitive modified rotation-advancement Millard repair was performed for all infants. Length of stay (LOS), time to discontinuation of IV fluids, and time to discontinuation of IV pain medicine were tallied for all patients. Collected demographic data included age and weight at definitive PCLR, gender, diagnosis (i.e., extent of cleft), and presence or absence of syndromic association. Lip-related surgical procedures (i.e., lip-nasal adhesion, presurgical orthodontia) done before definitive PCLR were also documented. A number of intraoperative factors were also studied, including duration of anesthesia, duration of surgery, total amount of IV fluids, and type and amount of local and systemic analgesic agents used in the procedure. Data
Duration of surgery (hours) Duration of anesthesia (hours) Total local anesthetic (mL) Total IV fluids (mL) Total acetaminophen (mg/kg) Total fentanyl (lg/kg) Total morphine (mg/kg)
2.5 3.4 3.3 221.5 29.2 3.9 0.16
6 6 6 6 6 6 6
0.9 0.9 1.5 83.2 9.8 1.8 0.10
Range 1.3–5.9 2.3–6.9 1.0–7.5 80–50 15.6–59.6 0.1–10.5 0.05–0.24
related to the post-anesthesia care unit (PACU) was collected, including time spent in PACU, total amount of IV fluids, type and amount of systemic analgesic agents, and, if applicable, the onset and amount of oral intake. Collected factors after admission to the floor included total amount of IV fluids, time until onset of adequate oral intake with discontinuation of IV fluids, and time until pain was sufficiently controlled by oral acetaminophen. All patients had routine orders to stop IV fluids when adequate oral intake had been established, as estimated by the Holliday-Segar calculation. All data analyses were conducted using Stata 11 software (StataCorp 2009). We evaluated the normality assumption before implementing analyses depending on parametric methods and used ladder of powers analyses to select an appropriate normalizing transformation. Thereafter, we used t tests and linear regression analyses to assess the strength of association and statistical significance of demographic, intraoperative, and postoperative characteristics as predictors of LOS. RESULTS A total of 100 consecutive infants undergoing PCLR were reviewed. There were no deaths or significant complications (e.g., lip dehiscence, infection, readmission). Demographic data are displayed in Table 1. Most patients had isolated cleft lip/palate; suspected syndromes or associations were documented in 15 infants, including suspected syndromes without molecular or clinical diagnosis (n ¼ 6), expanded spectrum hemifacial/craniofacial microsomia (n ¼ 4), van der Woude syndrome (n ¼ 1), ectodermal-ectrodactyly-clefting syndrome (n ¼ 1), WolfHirschhorn syndrome (n ¼ 1), partial trisomy 10p syndrome (n ¼ 1), and CHARGE association (n¼1). Presurgical orthodontia using a Latham appliance was performed in 21 patients, and lip-nasal adhesion was done in 26 patients. Intraoperative results are shown in Table 2. Data on duration of general anesthesia, duration of surgery, and total amount of intraoperative IV fluids were available for all 100 patients. Local infiltration of 0.5% lidocaine with 1:200,000 epinephrine was used in all patients, and the amount was documented in 96 patients. Fentanyl was administered to 98 patients, rectal acetaminophen was
Oh et al., LENGTH OF STAY AFTER PRIMARY CLEFT LIP REPAIR
TABLE 3
Factors Associated With the PACU
Total duration (hours) Total IV fluids (mL) Onset of oral intake (hours after admission to PACU) Total oral intake (mL/kg) Total acetaminophen (mg/kg) Total fentanyl (lg/kg) Total morphine (mg/kg)
TABLE 5 Factors Range
3.0 6 1.2 54.0 6 41.4
1.2–8.0 80–450
Increasing LOS
0.2–3.9 ,1–27.6 14.5–40.4 0.07–3.4 0.01–0.2
Decreasing LOS
6 6 6 6 6
0.8 6.2 8.8 0.7 0.04
given to 33 patients, and morphine was used in only 3 patients. Table 3 displays the results associated with the PACU. One patient with complex associated anomalies was directly admitted to the pediatric intensive care unit. Patients were in the PACU for an average of 3 hours. During this time, 83 patients began oral intake at a mean time of 1.5 hours after admission to the PACU; the amount ranged from sips to 27.6 mL/kg. Acetaminophen was given to 37 patients. Fentanyl and morphine were administered to 52 and 59 patients, respectively. Factors associated with care after transfer to the surgical floor are shown in Table 4. Overall mean LOS was approximately 36 hours for the group. The IV fluids were continued on the floor in 98% of patients; oral intake was documented at an average of 3.1 hours after transfer to the floor, irrespective of oral intake in the PACU. Adequate oral intake with discontinuation of IV fluids was documented in 95 patients, at a mean time of 24.1 hours after transfer to the floor. Despite orders to preferentially administer acetaminophen for postoperative pain management, 44% of patients required morphine supplementation for breakthrough pain 23 hours or more after hospital admission; the last administration of morphine was given at a mean time of 13.6 hours after transfer to the floor. Statistical analysis determined that the distribution of LOS was right skewed (log normal) and thus could be normalized by a log transformation to support the planned parametric analyses (Bland and Altman, 1996a; 1996b). Before reporting results based on LOS, they were back transformed (anti-logged) to return them to their original units. There was no evidence of significant differences in LOS associated with any patient factors (see Table 1). Univariate TABLE 4
Factors Associated With Inpatient Hospital Care
Length of stay (hours) Onset of oral intake (hours after transfer) Total oral intake (mL/kg) Time to discontinuation of IV fluids (hours after transfer) Time to last dose of morphine (hours after transfer) Total acetaminophen (mg/kg)
Univariate Regression Analysis of LOS and Hospital
Mean (6SD)
1.5 6.6 29.1 1.1 0.08
Mean (6SD)
Range
35.8 6 13.9 3.1 6 3.9 72.5 6 47.3
22.9–128.6 0.08–23.3 9.3–317.9
24.1 6 6.9
5–54
13.6 6 6.6 67.2 6 39.6
0.4–37.5 14.9–300.0
449
Associated Factors Duration of general anesthesia (P ¼ .0000) Duration of surgery (P ¼ .0000) Total IV fluids on the surgical floor (P ¼ .02) Time to oral intake on the surgical floor (P ¼ .009) Time to last dose of morphine on the surgical floor (P ¼ .0000) Total intraoperative local anesthetic (P ¼ .007) Total morphine in the PACU (P ¼ .02) Total morphine on the surgical floor (P ¼ .04) Total oral intake on the surgical floor (P ¼ .0000) Total acetaminophen on the surgical floor (P ¼ .0000)
linear regression analyses documented several significant correlations between LOS and various intraoperative and hospital factors; these are summarized in Table 5. Multivariate linear regression analyses demonstrated fewer significant associations. Greater duration of general anesthesia was correlated with longer LOS (P ¼ .002). Per contra, decreased LOS was associated with greater volume of postoperative oral intake (P ¼ .000) and higher acetaminophen dosage on the floor (P ¼ .000). DISCUSSION The current study sought to determine whether postoperative admission after PCLR is justified based on the hospital course of our patients with routine admission orders. Our findings support the need for inpatient admission for some patients and raise concerns about the safety and prudence of routine outpatient PCLR. Almost all of our patients were still receiving IV fluids after leaving the PACU, and although most began oral fluids within a few hours after the procedure, intake was not sufficient to discontinue the IV fluids. Moreover, 44% of the patients continued to have pain in excess of what could be controlled with oral acetaminophen. Although most of our patients could have been safely discharged within 23 hours (23-hour admission), a small minority still required IV fluid and analgesic supplementation. Although a prospective study would more conclusively answer the question of whether outpatient PCLR is as safe as some suggest, our results make us disinclined to implement such a protocol on a routine basis. Our results and conclusions conflict with those of several retrospective reports8–13 that attempt to demonstrate the apparent safety of ambulatory or short-stay repair of cleft lip and/or palate anomalies. Unlike our investigation, however, none of these reports attempted to analyze specific factors or elements associated with higher risk for failing outpatient cleft lip/palate surgery. Moreover, although these studies approach the issues more directly than our investigation, most suffer from serious flaws in methodology and do not conclusively settle the issue. Kim and Rothkopf (1999) reviewed the course of 24 patients
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Cleft Palate–Craniofacial Journal, July 2015, Vol. 52 No. 4
who underwent unilateral cleft lip repairs, approximately half of whom were discharged home the same day of surgery. Group selection was poorly described, except to note that patients in the ambulatory group were more frequently given a mixture of longer-lasting local anesthetic and dexamethasone than the inpatient group. In addition, follow-up was not documented, except to note that there were no complications among the ambulatory cleft lip repair group (Kim and Rothkopf, 1999). Rosen and colleagues (2003) compared outpatient cleft lip repair at one institution to inpatient cleft lip repair at another institution. The primary outcome measure, readmission rates within 4 weeks of repair, was found to be similar, although length of follow-up and patients lost to follow-up were not documented; in addition, the authors did not document whether there were any admissions or emergency department visits to outside facilities. Indian plastic surgeons reported successful outpatient repair of cleft lip, cleft palate, and palatal fistula using a tumescent technique in a variety of older patients, though a systematic analyses of outcomes was not performed (Saha et al., 2005). An interesting small study from Nigeria documented that 7.4% of mothers (N ¼ 2) reported ‘‘excessive crying’’ and ‘‘febrile illness’’ after ambulatory cleft lip repair (Ugburo et al., 2009). It should also be noted that although 27 patients were discharged home the same day of surgery, only eight families answered the telephone, which was the primary mode of follow-up during the first several days after surgery (Ugburo et al., 2009). It is our opinion that although these studies demonstrate no infant mortality after ambulatory PCLR, they do not adequately document whether the family’s course of home care was problematic (e.g., was there a need for additional outpatient hydration or medication) or quantify the stress or anxiety experienced by parents. Although the results of the current study suggest that categorical outpatient or short-stay discharge poses potential risks to some infants after PCLR, we extended our analysis to identify any patient and/or perioperative variables that might predict the need for and the length of postoperative admission or hospitalization. None of the patient factors in our study were found to have statistically significant associations with LOS. We were unable to document a correlation between gender, age, weight, severity of cleft, or syndromic diagnoses with overall hospital LOS. Other reports have similarly failed to find any similar associations with hospitalization or complications (Kim and Rothkopf, 1999; Saha et al., 2005; Ugburo et al., 2009). Cronin and colleagues (2001) excluded patients with syndromic diagnoses in their assessment of decreased LOS associated with cleft palate repair. Preexisting medical conditions may dictate inpatient cleft lip/palate procedures according to Rosen and colleagues (2003), a finding supported by Al-Thunyan and associates (2009) and Hopper and associates (2009). In this much larger, multiinstitutional study, the latter group documented that same-
day discharge was associated with older patient age, absence of comorbidities, private insurance, and surgery done at a hospital with a higher annual volume of primary cleft lip repair. In addition, the authors reported a statistically higher rate of readmission to the same institution in patients who were discharged the same day as surgery compared with patients who were admitted (2.8% versus 1.5%, P ¼ .03) (Hopper et al., 2009). Our analyses of various intraoperative and hospital factors documented several associations with LOS. As shown in Table 5, increasing LOS correlated with duration of general anesthesia (P ¼ .0000), duration of surgery (P ¼ .0000), total IV fluids on the surgical floor (P¼ .02), time to oral intake on the surgical floor (P ¼ .009), and time to last dose of morphine on the surgical floor (P ¼ .0000). Similarly, decreased LOS correlated with total intraoperative local anesthetic (P ¼ .007), total morphine in the PACU (P ¼ .02), total morphine on the surgical floor (P ¼ .04), total oral intake on the surgical floor (P ¼ .0000), and total acetaminophen on the surgical floor (P ¼ .0000). Multivariate linear regression models further narrowed the field of significant associations, documenting that greater LOS was correlated with duration of general anesthesia (P ¼ .002), whereas greater volume of postoperative oral intake (P ¼ .000) and higher acetaminophen dosage on the floor (P ¼ .000) correlated with decreased LOS. Although these findings intuitively make sense, our study results pinpoint these as variables that may be modified to influence patient LOS. In their small study of 24 patients undergoing cleft lip/palate procedures, Kim and Rothkopf (1999) documented that use of 0.5% bupivacaine and IV steroids was associated with successful outpatient management. This study has several limitations. First, because of its retrospective design, results and conclusions are less reliable than those from a prospective study. We are now working on tailoring the admission protocol at our institution based on the variables we identified. Nevertheless, we are reluctant, in light of our results, to attempt outpatient discharge for every patient. Second, our relatively small patient numbers also limit the power of the study, though they are similar to or greater than others in the literature the promote the safety of outpatient or short-stay admission for cleft lip/palate repair.8–13 In addition, all 100 patients in our study were consecutively included, which, we believe, strengthens our results. Another potential limitation of our study was the lack of regional local anesthesia, as several recent studies have shown better patient pain control with use of long-lasting local anesthetic agents (e.g., bupivacaine) as a regional block in children and adults undergoing cleft lip procedures (Jonnavithula et al., 2007; Morioka et al., 2007; Rajamani et al., 2007; Salloum et al., 2009; Takmaz et al., 2009; Sohail et al., 2010). Nevertheless, at least one report documented a similar need for systemic analgesia by 8 hours after regional block (Prabhu et al., 1999), limiting its utility in decreasing hospital LOS beyond
Oh et al., LENGTH OF STAY AFTER PRIMARY CLEFT LIP REPAIR
8 hours. Additionally, feeding difficulties have been demonstrated in patients who underwent regional block (Simion et al., 2008). Lastly, we recognize a potential treatment bias toward continuing IV pain medication and IV fluids beyond what might be necessary in this study, as all patients were routinely admitted after PCLR. A prospective randomized controlled trial with inpatient and outpatient groups would provide more definitive information. CONCLUSIONS Most infants undergoing PCLR received IV fluids after transfer to the floor and nearly half required IV pain medication beyond 23 hours after hospital admission. Greater LOS correlated with duration of general anesthesia, whereas greater volume of postoperative oral intake and higher acetaminophen dosage on the floor correlated with decreased LOS. Although certain factors could be modified or mitigated in an effort to reduce LOS, others may be out of the clinician’s control. These findings question the safety of routine outpatient or short-stay observation after PCLR. A well-designed prospective study is necessary to corroborate these results. REFERENCES Al-Thunyan AM, Aldekhayel SA, Al-Meshal O, Al-Qattan MM. Ambulatory cleft lip repair. Plast Reconstr Surg. 2009;124:2048– 2053. Bland JM, Altman DG. Statistics notes: Transformations, means, and confidence intervals. BMJ. 1996a;312:107. Bland JM, Altman DG. The use of transformation when comparing two means. BMJ. 1996b;312:1153. Canady JW, Glowacki R, Thompson SA, Morris HL. Complication outcomes based on preoperative admission and length of stay for primary palatoplasty and cleft lip/palate revision in children aged 1 to 6 years. Ann Plast Surg. 1994;33:576–580. Centers for Disease Control and Prevention. Birth Defects: Data and Statistics: In the United States. Available at http://www.cdc.gov/ NCBDDD/birthdefects/data.html. Accessed November 15, 2012. Cronin ED, Williams JL, Shayani P, Roesel JF. Short stay after cleft palate surgery. Plast Reconstr Surg. 2001;108:838–840. Eaton AC, Marsh JL, Pilgram TK. Does reduced hospital stay affect morbidity and mortality rates following cleft lip and palate repair in infancy? Plast Reconstr Surg. 1994;94:911–915. Hopper RA, Lewis C, Umbdenstock R, Garrison MM, Starr JR. Discharge practices, readmission, and serious medical complications following primary cleft lip repair in 23 U.S. children’s hospitals. Plast Reconstr Surg. 2009;123:1553–1559.
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Jonnavithula N, Durga P, Kulkarni DK, Ramachandran G. Bilateral intra-oral, infra-orbital nerve block for postoperative analgesia following cleft lip repair in paediatric patients: comparison of bupivacaine vs bupivacaine-pethidine combination. Anaesthesia. 2007;62:581–585. Kim TH, Rothkopf DM. Ambulatory surgery for cleft lip repair. Ann Plast Surg. 1999;42:442–444. Lees VC, Pigott RW. Early postoperative complications in primary cleft lip and palate surgery— how soon may we discharge patients from hospital? Br J Plast Surg. 1992;45:232–234. Lewis MB. Discussion—does reduced hospital stay affect morbidity and mortality rates following cleft lip and palate repair in infancy? Plast Reconstr Surg. 1994;94:916–918. Morioka D, Yoshimoto S, Udagawa A, Ohkubo F, Yoshikawa A. Primary repair in adult patients with untreated cleft lip-cleft palate. Plast Reconstr Surg. 2007;120:1981–1988. Obama, B. Remarks by the President at the Opening of the White House Forum on Health Reform, March 5, 2009. Available at http://www.whitehouse.gov/the-press-office/remarks-presidentopening-white-house-forum-health-reform. Accessed December 17, 2012. Pastores SM, Dakwar J, Halpern NA. Costs of critical care medicine. Crit Care Clin. 2012;28:1–10. Prabhu KP, Wig J, Grewal S. Bilateral infraorbital nerve block is superior to peri-incisional infiltration for analgesia after repair of cleft lip. Scand J Plast Reconstr Surg Hand Surg. 1999;33:8–87. Rajamani A, Kamat V, Rajavel VP, Murthy J, Hussain SA. A comparison of bilateral infraorbital nerve block with intravenous fentanyl for analgesia following cleft lip repair in children. Paediatr Anaesth. 2007;17:133–139. Rosen H, Barrios LM, Reinisch JF, Macgill K, Meara JG. Outpatient cleft lip repair. Plast Reconstr Surg. 2003;112:381–387. Saha SS, Kumar V, Khazanchi RK, Aggarwal A, Taneja R, Sood J, Sharma S. Ambulatory cleft lip and palate surgery by tumescent technique. Plast Reconstr Surg. 2005;115:1210–1212. Salloum ML, Eberlin KR, Sethna N, Hamdan US. Combined use of infraorbital and external nasal nerve blocks for effective perioperative pain control during and after cleft lip repair. Cleft Palate Craniofac J. 2009;46:629–635. Simion C, Corcoran J, Iyer A, Suresh S. Postoperative pain control for primary cleft lip repair in infants: is there an advantage in performing peripheral nerve blocks? Paediatr Anaesth. 2008;18:1060–1065. Sohail M, Khan FA, Mir ZA. Comparison of ambulatory and inpatient cleft lip surgery for adults. J Ayub Med Coll Abbottabad. 2010;22:71–74. StataCorp. Stata Statistical Software: Release 11, College Station, TX: StataCorp LP, 2009. Takmaz SA, Uysal HY, Uysal A, Kocer U, Dikmen B, Baltaci B. Bilateral extraoral, infraorbital nerve block for postoperative pain relief after cleft lip repair in pediatric patients: a randomized, double-blind controlled study. Ann Plast Surg. 2009;63:59–62. Ugburo AO, Desalu I, Adekola AF, Fadeyibi IO. Day case cleft lip surgery in Lagos, Nigeria. Cleft Palate Craniofac J. 2009;46:636– 641.
ORIGINAL ARTICLE Clinical Factors Affecting Length of Stay After 100 Consecutive Cases of Primary Cleft Lip Repair Albert K. Oh, M.D., Keshav Magge, M.D., Tina M. Sauerhammer, M.D., Jacqueline Kim, Mahlet Atnafu, Michael J. Boyajian, M.D., Gary F. Rogers, M.D., J.D., M.B.A. Objective: To analyze the hospital course of 100 consecutive infants after primary cleft lip repair (PCLR) and identify factors related to length of stay (LOS). Design: Retrospective analysis of 100 consecutive infants who were routinely admitted after PCLR. Setting: Tertiary care center. Patients: One hundred consecutive infants undergoing PCLR. Demographic and perioperative data were collected and analyzed. Main Outcome Measure: LOS, planned before data collection. Results: Male:female ratio was 65:35. Seventy-two infants had unilateral cleft lip; syndromic association was documented in 15 patients. Mean age and weight at PCLR were 5.6 6 4.0 months and 6.7 6 1.3 kg, respectively. Mean duration of surgery was 2.5 6 0.9 hours, and mean duration of general anesthesia was 3.4 6 0.9 hours. A total of 3.3 6 1.5 mL of intraoperative local anesthetic was used per patient. Intravenous fluids were necessary after transfer from the postanesthesia care unit to the general ward in 98% of patients. Almost half (44%) of all patients received intravenous morphine 23 hours or more after hospital admission. Mean LOS was 35.8 6 13.9 hours. No association was identified between patient demographic factors and LOS. Multivariate linear regression models identified significant positive correlation between LOS and duration of general anesthesia (P ¼ .002). Greater volume of postoperative oral intake (P ¼ .000) and higher acetaminophen dosage on the floor (P ¼ .000) correlated with decreased LOS. Conclusions: This study identifies perioperative factors associated with LOS. Our findings question the safety of routine outpatient or short-stay observation after PCLR. KEY WORDS:
cleft lip repair, postoperative admission, length of stay
The cost of health care in the United States is the highest in the world; national health expenditures totaled $2.5 trillion or 17.6% of the nation’s gross domestic product in 2009. That same year, President Barack Obama (2009) stated that, ‘‘by a wide margin, the biggest threat to our nation’s balance sheet is the skyrocketing cost of health care.’’ Providing safe and efficacious care with the least waste of resources should be the goal of health policy officials all over the world. Nevertheless, despite all efforts,
the cost of health care in the United States continues to climb at an exponential rate (Pastores et al., 2012). The push to reduce health care expenses has led many medical stakeholders to challenge traditional practices and standards of care. One of the most rigidly scrutinized areas is the need for inpatient hospitalization. Although it is economically intuitive that reducing the amount and intensity of patient monitoring will reduce costs, such objectives must be carefully balanced against the human and economic cost of a possible increase in morbidity and mortality. This tension has been felt in nearly every area of medicine; in the subspecialty of pediatric plastic surgery, one of the most contentiously debated issues is whether admission after primary cleft lip repair (PCLR) is necessary. Cleft lip with or without cleft palate is the most common craniofacial malformation; it affects 1 in 940 live births and results in an estimated 4,437 annual cases (Centers for Disease Control and Prevention, 2012). PCLR is typically performed within the first several months of life, during a period of relative high risk for postoperative airway compromise and dehydration. In the early 1990s, Lees
Dr. Oh is Assistant Professor, Dr. Magge is Fellow, Dr. Sauerhammer is Assistant Professor, Ms. Kim is undergraduate student, Ms. Atnafu is undergraduate student, Dr. Boyajian is Assistant Professor, and Dr. Rogers is Associate Professor, Division of Plastic and Reconstructive Surgery, Children’s National Medical Center, George Washington University, Washington, D.C. Presented at the 12th International Congress on Cleft Lip/Palate and Related Craniofacial Anomalies, Orlando, Florida, May 7, 2013. Submitted January 2014; Accepted May 2014. Address correspondence to: Dr. Albert K. Oh, Division of Plastic and Reconstructive Surgery, Children’s National Medical Center, 111 Michigan Avenue, NW, Washington, D.C. 20010. E-mail aoh@ childrensnational.org. DOI: 10.1597/14-006 447
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Cleft Palate–Craniofacial Journal, July 2015, Vol. 52 No. 4
TABLE 1
Demographics of the Study Group
TABLE 2
Intraoperative Factors
Characteristics
Mean (6SD)
Boys:girls Mean (6SD) age (months) Mean (6SD) weight (kg) Diagnosis Unilateral complete cleft lip and/or palate Unilateral incomplete cleft lip and/or palate Bilateral complete cleft lip and/or palate Bilateral incomplete cleft lip and/or palate Syndromic:isolated
65:35 5.5 6 3.9 6.7 6 1.3 43 29 17 11 85:15
and Pigott (1992) demonstrated that admission before cleft lip/palate repair did not significantly improve outcomes. The results of this study and others in the early 1990s (Canady et al., 1994; Eaton et al., 1994) led to the discontinuation of routine admission before elective cleft lip or palatal procedures. In the next decade, as astutely predicted by Lewis (1994), investigators began to question the need for admission after cleft lip and cleft palatal repair. Several retrospective reports (Kim and Rothkopf, 1999; Cronin et al., 2001; Rosen et al., 2003; Saha et al., 2005; AlThunyan 2009; Ugburo et al., 2009) in relatively small number of patients with various forms of cleft lip/palate seem to demonstrate the apparent safety of ambulatory or short-stay repair of these anomalies. Thus, routine inpatient admission after PCLR may be unnecessary. The policy at our institution has been to routinely admit patients undergoing cleft lip/palate procedures on the day of surgical repair, anticipating a 1- or 2-day postoperative admission for intravenous (IV) hydration and pain control. In light of the reports outlined earlier, we reviewed the perioperative course of 100 consecutive infants undergoing PCLR to determine if these patients could have potentially been managed in a short-stay observational or outpatient status and to identify operative and postoperative factors that might predict the need for postoperative admission. PATIENTS
AND
METHODS
After obtaining institutional review board approval, the authors reviewed 100 consecutive infants undergoing PCLR from January 2008 to April 2012. A definitive modified rotation-advancement Millard repair was performed for all infants. Length of stay (LOS), time to discontinuation of IV fluids, and time to discontinuation of IV pain medicine were tallied for all patients. Collected demographic data included age and weight at definitive PCLR, gender, diagnosis (i.e., extent of cleft), and presence or absence of syndromic association. Lip-related surgical procedures (i.e., lip-nasal adhesion, presurgical orthodontia) done before definitive PCLR were also documented. A number of intraoperative factors were also studied, including duration of anesthesia, duration of surgery, total amount of IV fluids, and type and amount of local and systemic analgesic agents used in the procedure. Data
Duration of surgery (hours) Duration of anesthesia (hours) Total local anesthetic (mL) Total IV fluids (mL) Total acetaminophen (mg/kg) Total fentanyl (lg/kg) Total morphine (mg/kg)
2.5 3.4 3.3 221.5 29.2 3.9 0.16
6 6 6 6 6 6 6
0.9 0.9 1.5 83.2 9.8 1.8 0.10
Range 1.3–5.9 2.3–6.9 1.0–7.5 80–50 15.6–59.6 0.1–10.5 0.05–0.24
related to the post-anesthesia care unit (PACU) was collected, including time spent in PACU, total amount of IV fluids, type and amount of systemic analgesic agents, and, if applicable, the onset and amount of oral intake. Collected factors after admission to the floor included total amount of IV fluids, time until onset of adequate oral intake with discontinuation of IV fluids, and time until pain was sufficiently controlled by oral acetaminophen. All patients had routine orders to stop IV fluids when adequate oral intake had been established, as estimated by the Holliday-Segar calculation. All data analyses were conducted using Stata 11 software (StataCorp 2009). We evaluated the normality assumption before implementing analyses depending on parametric methods and used ladder of powers analyses to select an appropriate normalizing transformation. Thereafter, we used t tests and linear regression analyses to assess the strength of association and statistical significance of demographic, intraoperative, and postoperative characteristics as predictors of LOS. RESULTS A total of 100 consecutive infants undergoing PCLR were reviewed. There were no deaths or significant complications (e.g., lip dehiscence, infection, readmission). Demographic data are displayed in Table 1. Most patients had isolated cleft lip/palate; suspected syndromes or associations were documented in 15 infants, including suspected syndromes without molecular or clinical diagnosis (n ¼ 6), expanded spectrum hemifacial/craniofacial microsomia (n ¼ 4), van der Woude syndrome (n ¼ 1), ectodermal-ectrodactyly-clefting syndrome (n ¼ 1), WolfHirschhorn syndrome (n ¼ 1), partial trisomy 10p syndrome (n ¼ 1), and CHARGE association (n¼1). Presurgical orthodontia using a Latham appliance was performed in 21 patients, and lip-nasal adhesion was done in 26 patients. Intraoperative results are shown in Table 2. Data on duration of general anesthesia, duration of surgery, and total amount of intraoperative IV fluids were available for all 100 patients. Local infiltration of 0.5% lidocaine with 1:200,000 epinephrine was used in all patients, and the amount was documented in 96 patients. Fentanyl was administered to 98 patients, rectal acetaminophen was
Oh et al., LENGTH OF STAY AFTER PRIMARY CLEFT LIP REPAIR
TABLE 3
Factors Associated With the PACU
Total duration (hours) Total IV fluids (mL) Onset of oral intake (hours after admission to PACU) Total oral intake (mL/kg) Total acetaminophen (mg/kg) Total fentanyl (lg/kg) Total morphine (mg/kg)
TABLE 5 Factors Range
3.0 6 1.2 54.0 6 41.4
1.2–8.0 80–450
Increasing LOS
0.2–3.9 ,1–27.6 14.5–40.4 0.07–3.4 0.01–0.2
Decreasing LOS
6 6 6 6 6
0.8 6.2 8.8 0.7 0.04
given to 33 patients, and morphine was used in only 3 patients. Table 3 displays the results associated with the PACU. One patient with complex associated anomalies was directly admitted to the pediatric intensive care unit. Patients were in the PACU for an average of 3 hours. During this time, 83 patients began oral intake at a mean time of 1.5 hours after admission to the PACU; the amount ranged from sips to 27.6 mL/kg. Acetaminophen was given to 37 patients. Fentanyl and morphine were administered to 52 and 59 patients, respectively. Factors associated with care after transfer to the surgical floor are shown in Table 4. Overall mean LOS was approximately 36 hours for the group. The IV fluids were continued on the floor in 98% of patients; oral intake was documented at an average of 3.1 hours after transfer to the floor, irrespective of oral intake in the PACU. Adequate oral intake with discontinuation of IV fluids was documented in 95 patients, at a mean time of 24.1 hours after transfer to the floor. Despite orders to preferentially administer acetaminophen for postoperative pain management, 44% of patients required morphine supplementation for breakthrough pain 23 hours or more after hospital admission; the last administration of morphine was given at a mean time of 13.6 hours after transfer to the floor. Statistical analysis determined that the distribution of LOS was right skewed (log normal) and thus could be normalized by a log transformation to support the planned parametric analyses (Bland and Altman, 1996a; 1996b). Before reporting results based on LOS, they were back transformed (anti-logged) to return them to their original units. There was no evidence of significant differences in LOS associated with any patient factors (see Table 1). Univariate TABLE 4
Factors Associated With Inpatient Hospital Care
Length of stay (hours) Onset of oral intake (hours after transfer) Total oral intake (mL/kg) Time to discontinuation of IV fluids (hours after transfer) Time to last dose of morphine (hours after transfer) Total acetaminophen (mg/kg)
Univariate Regression Analysis of LOS and Hospital
Mean (6SD)
1.5 6.6 29.1 1.1 0.08
Mean (6SD)
Range
35.8 6 13.9 3.1 6 3.9 72.5 6 47.3
22.9–128.6 0.08–23.3 9.3–317.9
24.1 6 6.9
5–54
13.6 6 6.6 67.2 6 39.6
0.4–37.5 14.9–300.0
449
Associated Factors Duration of general anesthesia (P ¼ .0000) Duration of surgery (P ¼ .0000) Total IV fluids on the surgical floor (P ¼ .02) Time to oral intake on the surgical floor (P ¼ .009) Time to last dose of morphine on the surgical floor (P ¼ .0000) Total intraoperative local anesthetic (P ¼ .007) Total morphine in the PACU (P ¼ .02) Total morphine on the surgical floor (P ¼ .04) Total oral intake on the surgical floor (P ¼ .0000) Total acetaminophen on the surgical floor (P ¼ .0000)
linear regression analyses documented several significant correlations between LOS and various intraoperative and hospital factors; these are summarized in Table 5. Multivariate linear regression analyses demonstrated fewer significant associations. Greater duration of general anesthesia was correlated with longer LOS (P ¼ .002). Per contra, decreased LOS was associated with greater volume of postoperative oral intake (P ¼ .000) and higher acetaminophen dosage on the floor (P ¼ .000). DISCUSSION The current study sought to determine whether postoperative admission after PCLR is justified based on the hospital course of our patients with routine admission orders. Our findings support the need for inpatient admission for some patients and raise concerns about the safety and prudence of routine outpatient PCLR. Almost all of our patients were still receiving IV fluids after leaving the PACU, and although most began oral fluids within a few hours after the procedure, intake was not sufficient to discontinue the IV fluids. Moreover, 44% of the patients continued to have pain in excess of what could be controlled with oral acetaminophen. Although most of our patients could have been safely discharged within 23 hours (23-hour admission), a small minority still required IV fluid and analgesic supplementation. Although a prospective study would more conclusively answer the question of whether outpatient PCLR is as safe as some suggest, our results make us disinclined to implement such a protocol on a routine basis. Our results and conclusions conflict with those of several retrospective reports8–13 that attempt to demonstrate the apparent safety of ambulatory or short-stay repair of cleft lip and/or palate anomalies. Unlike our investigation, however, none of these reports attempted to analyze specific factors or elements associated with higher risk for failing outpatient cleft lip/palate surgery. Moreover, although these studies approach the issues more directly than our investigation, most suffer from serious flaws in methodology and do not conclusively settle the issue. Kim and Rothkopf (1999) reviewed the course of 24 patients
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who underwent unilateral cleft lip repairs, approximately half of whom were discharged home the same day of surgery. Group selection was poorly described, except to note that patients in the ambulatory group were more frequently given a mixture of longer-lasting local anesthetic and dexamethasone than the inpatient group. In addition, follow-up was not documented, except to note that there were no complications among the ambulatory cleft lip repair group (Kim and Rothkopf, 1999). Rosen and colleagues (2003) compared outpatient cleft lip repair at one institution to inpatient cleft lip repair at another institution. The primary outcome measure, readmission rates within 4 weeks of repair, was found to be similar, although length of follow-up and patients lost to follow-up were not documented; in addition, the authors did not document whether there were any admissions or emergency department visits to outside facilities. Indian plastic surgeons reported successful outpatient repair of cleft lip, cleft palate, and palatal fistula using a tumescent technique in a variety of older patients, though a systematic analyses of outcomes was not performed (Saha et al., 2005). An interesting small study from Nigeria documented that 7.4% of mothers (N ¼ 2) reported ‘‘excessive crying’’ and ‘‘febrile illness’’ after ambulatory cleft lip repair (Ugburo et al., 2009). It should also be noted that although 27 patients were discharged home the same day of surgery, only eight families answered the telephone, which was the primary mode of follow-up during the first several days after surgery (Ugburo et al., 2009). It is our opinion that although these studies demonstrate no infant mortality after ambulatory PCLR, they do not adequately document whether the family’s course of home care was problematic (e.g., was there a need for additional outpatient hydration or medication) or quantify the stress or anxiety experienced by parents. Although the results of the current study suggest that categorical outpatient or short-stay discharge poses potential risks to some infants after PCLR, we extended our analysis to identify any patient and/or perioperative variables that might predict the need for and the length of postoperative admission or hospitalization. None of the patient factors in our study were found to have statistically significant associations with LOS. We were unable to document a correlation between gender, age, weight, severity of cleft, or syndromic diagnoses with overall hospital LOS. Other reports have similarly failed to find any similar associations with hospitalization or complications (Kim and Rothkopf, 1999; Saha et al., 2005; Ugburo et al., 2009). Cronin and colleagues (2001) excluded patients with syndromic diagnoses in their assessment of decreased LOS associated with cleft palate repair. Preexisting medical conditions may dictate inpatient cleft lip/palate procedures according to Rosen and colleagues (2003), a finding supported by Al-Thunyan and associates (2009) and Hopper and associates (2009). In this much larger, multiinstitutional study, the latter group documented that same-
day discharge was associated with older patient age, absence of comorbidities, private insurance, and surgery done at a hospital with a higher annual volume of primary cleft lip repair. In addition, the authors reported a statistically higher rate of readmission to the same institution in patients who were discharged the same day as surgery compared with patients who were admitted (2.8% versus 1.5%, P ¼ .03) (Hopper et al., 2009). Our analyses of various intraoperative and hospital factors documented several associations with LOS. As shown in Table 5, increasing LOS correlated with duration of general anesthesia (P ¼ .0000), duration of surgery (P ¼ .0000), total IV fluids on the surgical floor (P¼ .02), time to oral intake on the surgical floor (P ¼ .009), and time to last dose of morphine on the surgical floor (P ¼ .0000). Similarly, decreased LOS correlated with total intraoperative local anesthetic (P ¼ .007), total morphine in the PACU (P ¼ .02), total morphine on the surgical floor (P ¼ .04), total oral intake on the surgical floor (P ¼ .0000), and total acetaminophen on the surgical floor (P ¼ .0000). Multivariate linear regression models further narrowed the field of significant associations, documenting that greater LOS was correlated with duration of general anesthesia (P ¼ .002), whereas greater volume of postoperative oral intake (P ¼ .000) and higher acetaminophen dosage on the floor (P ¼ .000) correlated with decreased LOS. Although these findings intuitively make sense, our study results pinpoint these as variables that may be modified to influence patient LOS. In their small study of 24 patients undergoing cleft lip/palate procedures, Kim and Rothkopf (1999) documented that use of 0.5% bupivacaine and IV steroids was associated with successful outpatient management. This study has several limitations. First, because of its retrospective design, results and conclusions are less reliable than those from a prospective study. We are now working on tailoring the admission protocol at our institution based on the variables we identified. Nevertheless, we are reluctant, in light of our results, to attempt outpatient discharge for every patient. Second, our relatively small patient numbers also limit the power of the study, though they are similar to or greater than others in the literature the promote the safety of outpatient or short-stay admission for cleft lip/palate repair.8–13 In addition, all 100 patients in our study were consecutively included, which, we believe, strengthens our results. Another potential limitation of our study was the lack of regional local anesthesia, as several recent studies have shown better patient pain control with use of long-lasting local anesthetic agents (e.g., bupivacaine) as a regional block in children and adults undergoing cleft lip procedures (Jonnavithula et al., 2007; Morioka et al., 2007; Rajamani et al., 2007; Salloum et al., 2009; Takmaz et al., 2009; Sohail et al., 2010). Nevertheless, at least one report documented a similar need for systemic analgesia by 8 hours after regional block (Prabhu et al., 1999), limiting its utility in decreasing hospital LOS beyond
Oh et al., LENGTH OF STAY AFTER PRIMARY CLEFT LIP REPAIR
8 hours. Additionally, feeding difficulties have been demonstrated in patients who underwent regional block (Simion et al., 2008). Lastly, we recognize a potential treatment bias toward continuing IV pain medication and IV fluids beyond what might be necessary in this study, as all patients were routinely admitted after PCLR. A prospective randomized controlled trial with inpatient and outpatient groups would provide more definitive information. CONCLUSIONS Most infants undergoing PCLR received IV fluids after transfer to the floor and nearly half required IV pain medication beyond 23 hours after hospital admission. Greater LOS correlated with duration of general anesthesia, whereas greater volume of postoperative oral intake and higher acetaminophen dosage on the floor correlated with decreased LOS. Although certain factors could be modified or mitigated in an effort to reduce LOS, others may be out of the clinician’s control. These findings question the safety of routine outpatient or short-stay observation after PCLR. A well-designed prospective study is necessary to corroborate these results. REFERENCES Al-Thunyan AM, Aldekhayel SA, Al-Meshal O, Al-Qattan MM. Ambulatory cleft lip repair. Plast Reconstr Surg. 2009;124:2048– 2053. Bland JM, Altman DG. Statistics notes: Transformations, means, and confidence intervals. BMJ. 1996a;312:107. Bland JM, Altman DG. The use of transformation when comparing two means. BMJ. 1996b;312:1153. Canady JW, Glowacki R, Thompson SA, Morris HL. Complication outcomes based on preoperative admission and length of stay for primary palatoplasty and cleft lip/palate revision in children aged 1 to 6 years. Ann Plast Surg. 1994;33:576–580. Centers for Disease Control and Prevention. Birth Defects: Data and Statistics: In the United States. Available at http://www.cdc.gov/ NCBDDD/birthdefects/data.html. Accessed November 15, 2012. Cronin ED, Williams JL, Shayani P, Roesel JF. Short stay after cleft palate surgery. Plast Reconstr Surg. 2001;108:838–840. Eaton AC, Marsh JL, Pilgram TK. Does reduced hospital stay affect morbidity and mortality rates following cleft lip and palate repair in infancy? Plast Reconstr Surg. 1994;94:911–915. Hopper RA, Lewis C, Umbdenstock R, Garrison MM, Starr JR. Discharge practices, readmission, and serious medical complications following primary cleft lip repair in 23 U.S. children’s hospitals. Plast Reconstr Surg. 2009;123:1553–1559.
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Jonnavithula N, Durga P, Kulkarni DK, Ramachandran G. Bilateral intra-oral, infra-orbital nerve block for postoperative analgesia following cleft lip repair in paediatric patients: comparison of bupivacaine vs bupivacaine-pethidine combination. Anaesthesia. 2007;62:581–585. Kim TH, Rothkopf DM. Ambulatory surgery for cleft lip repair. Ann Plast Surg. 1999;42:442–444. Lees VC, Pigott RW. Early postoperative complications in primary cleft lip and palate surgery— how soon may we discharge patients from hospital? Br J Plast Surg. 1992;45:232–234. Lewis MB. Discussion—does reduced hospital stay affect morbidity and mortality rates following cleft lip and palate repair in infancy? Plast Reconstr Surg. 1994;94:916–918. Morioka D, Yoshimoto S, Udagawa A, Ohkubo F, Yoshikawa A. Primary repair in adult patients with untreated cleft lip-cleft palate. Plast Reconstr Surg. 2007;120:1981–1988. Obama, B. Remarks by the President at the Opening of the White House Forum on Health Reform, March 5, 2009. Available at http://www.whitehouse.gov/the-press-office/remarks-presidentopening-white-house-forum-health-reform. Accessed December 17, 2012. Pastores SM, Dakwar J, Halpern NA. Costs of critical care medicine. Crit Care Clin. 2012;28:1–10. Prabhu KP, Wig J, Grewal S. Bilateral infraorbital nerve block is superior to peri-incisional infiltration for analgesia after repair of cleft lip. Scand J Plast Reconstr Surg Hand Surg. 1999;33:8–87. Rajamani A, Kamat V, Rajavel VP, Murthy J, Hussain SA. A comparison of bilateral infraorbital nerve block with intravenous fentanyl for analgesia following cleft lip repair in children. Paediatr Anaesth. 2007;17:133–139. Rosen H, Barrios LM, Reinisch JF, Macgill K, Meara JG. Outpatient cleft lip repair. Plast Reconstr Surg. 2003;112:381–387. Saha SS, Kumar V, Khazanchi RK, Aggarwal A, Taneja R, Sood J, Sharma S. Ambulatory cleft lip and palate surgery by tumescent technique. Plast Reconstr Surg. 2005;115:1210–1212. Salloum ML, Eberlin KR, Sethna N, Hamdan US. Combined use of infraorbital and external nasal nerve blocks for effective perioperative pain control during and after cleft lip repair. Cleft Palate Craniofac J. 2009;46:629–635. Simion C, Corcoran J, Iyer A, Suresh S. Postoperative pain control for primary cleft lip repair in infants: is there an advantage in performing peripheral nerve blocks? Paediatr Anaesth. 2008;18:1060–1065. Sohail M, Khan FA, Mir ZA. Comparison of ambulatory and inpatient cleft lip surgery for adults. J Ayub Med Coll Abbottabad. 2010;22:71–74. StataCorp. Stata Statistical Software: Release 11, College Station, TX: StataCorp LP, 2009. Takmaz SA, Uysal HY, Uysal A, Kocer U, Dikmen B, Baltaci B. Bilateral extraoral, infraorbital nerve block for postoperative pain relief after cleft lip repair in pediatric patients: a randomized, double-blind controlled study. Ann Plast Surg. 2009;63:59–62. Ugburo AO, Desalu I, Adekola AF, Fadeyibi IO. Day case cleft lip surgery in Lagos, Nigeria. Cleft Palate Craniofac J. 2009;46:636– 641.
