Surgery for Obesity and Related Diseases ] (2015) 00–00
Original article
Prospective randomized double-blind controlled trial of continuous local anesthetic infusion to reduce narcotic use in laparoscopic sleeve gastrectomy Elaine M. Cleveland, M.D.*, Gregory S. Peirce, M.D., Josiah D. Freemyer, M.D., John P. Schriver, M.D., Eric P. Ahnfeldt, D.O., William V. Rice, M.D. General Surgery Department, William Beaumont Army Medical Center, El Paso, Texas. Received October 3, 2014; accepted December 27, 2014
Abstract
Background: In an era of cost containment and outcome-based medicine, bariatric surgeons are attempting to decrease perioperative morbidity and streamline care. One way of accomplishing this is by decreasing opioid use and hospital stay. Several studies of nonbariatric open procedures have shown that continuous infusion catheters (CIC) are beneficial. Bariatric surgeons frequently utilize CIC, but the data is sparse for the clinical efficacy in laparoscopic procedures. Objective: Evaluate the efficacy of CIC in laparoscopic sleeve gastrectomy. Setting: military teaching hospital. Methods: In this single institution prospective randomized double-blind controlled study, 82 patients undergoing laparoscopic sleeve gastrectomy (LSG) received either .2% ropivacaine or .9% normal saline (placebo) via CIC. After discharge, total narcotic usage, total antiemetic usage, pain scores, and hospital length of stay were evaluated. A one-way ANOVA was used to assess statistical significance. Power was 80% to detect 52 mg morphine equivalent difference. Results: A total of 82 patients were enrolled, 39 received ropivacaine, and 43 received placebo. There was no statistically significant difference in narcotic usage between the ropivacaine group and placebo group, 51.9 mg versus 55.2 mg, respectively (P ¼ .63). Ondansetron usage was 10.7 mg and 10.6 mg for ropivacaine and placebo groups. (P ¼ .98). Average pain score was 3.0 for each group (P ¼ .632). Total hospital length of stay was 37.5 hours for ropivacaine group and 38.1 hours for placebo group (P ¼ .768). Conclusions: We found no difference in narcotic usage, antiemetic usage, pain scores, or hospital length of stay between ropivacaine and placebo groups. We conclude there is no utility of CIC in LSG. (Surg Obes Relat Dis 2015;]:00–00.) Published by Elsevier Inc. on behalf of American Society for Metabolic and Bariatric Surgery.
Keywords:
Continuous infusion catheters; Laparoscopic sleeve gastrectomy; Narcotic usage
Constant scrutiny of costs while maintaining quality care is omnipresent in the delivery of healthcare today. Continuous infusion catheters (CIC) for postoperative pain management have been shown to reduce the following: narcotic usage [1], time until ambulation, pain scores [2], time to return of bowel function [3], postoperative nausea, *
Correspondence: Elaine Cleveland, 5005 N Piedras Dr, El Paso, TX 79920. Tel.: þ915 742 2698; fax: þ915 742 7889. E-mail: [email protected]
and vomiting. CIC have also been shown to increase patient satisfaction scores [4]. However, these benefits were realized in studies evaluating open colectomy [5,6], laparotomy [7], open inguinal hernia repair [8], hysterectomy [9], thoracotomy[10], sternotomy [11], orthopedic procedures [12,13], and a multivariate analysis of multiple different surgical procedures [4,14]. Despite the increasing number of bariatric procedures being performed, there is a comparative shortage of literature regarding CIC in bariatric surgery [15,16]. A
http://dx.doi.org/10.1016/j.soard.2014.12.030 1550-7289/Published by Elsevier Inc. on behalf of American Society for Metabolic and Bariatric Surgery.
2
E. M. Cleveland et al. / Surgery for Obesity and Related Diseases ] (2015) 00–00
retrospective review from 2013 showed decreased narcotic usage in laparoscopic Roux-en-Y Gastric Bypass (LRYGB) patients receiving CIC analgesia compared to those without the catheter [17]. Laparoscopic sleeve gastrectomy (LSG) is becoming more popular due to perceived technical simplicity, feasibility, and good patient outcomes with regard to weight loss and improvement in co-morbidities [18,19]. Many bariatric surgery centers implement protocols to treat LSG patients similar to LRYGB patients, even with regards to postoperative pain management. However, LSG patients have less manipulation of the bowel, fewer ports, and shorter operative times. The CIC are not without their own cost and complications. At our hospital, the ropivacaine filled pain pump costs $284 and the bariatric catheter insertion set costs $426, equaling $710 per patient. Placement of the CIC can lengthen operative time, cause skin irritation, or cause infection [20]. The purpose of our study was to determine if CIC were effective in improving the following parameters: opioid usage, antiemetic usage, patient controlled analgesia (PCA) attempts, hospital stay, and pain scores in the peri-operative period following a LSG. We also tracked adverse events such as urinary retention and hypoxic episodes to determine if there was any difference between the 2 groups. Our aim was to determine if there was a difference in these parameters. If no difference existed, the CIC would be discontinued, thus decreasing the cost of LSG without compromising care. Methods After Institutional Review Board approval, patients were enrolled at a single institution from January 2013 until April 2014. Patients were recruited from those that qualified for bariatric surgery (418 years, body mass index (BMI) 440 or 435 with co-morbidities, attempt at previous weight loss, psychiatric clearance, and meeting with a nutritionist) and were to undergo LSG with standard 4 port placement as an initial bariatric procedure. All patients meeting the above criteria, including those with chronic pain and chronic opioid use, were eligible for inclusion. A research resident would enroll patients and send the patient demographic characteristics and consent to the pharmacy. Exclusion criteria included revision surgery, single-incision surgery, and history of allergy to local anesthetic. There were 4 different attending surgeons who followed the same methodology for LSG. Two surgeons did 60% of cases while the other 2 did the remaining 40%. Residents ranging in experience from postgraduate year (PGY) PGY-1 to PGY-5 were involved in the operation as well as the perioperative care. The pharmacist randomized patients using a coin flip and then filled the 600 cc elastometric pump with either .9%
injectable normal saline or .2% ropivacaine. The pump was labeled with patient identification, and was distributed to the operating room before the start of the procedure. The content of the CIC was not known by the patient, the operating surgeons, nurses, or the data collectors until completion of data analysis. Placement of the catheter After gaining laparoscopic access to the abdomen with an optical viewing trocar, 2 continuous infusion catheters (20 ga) were placed percutaneously under direct visualization into the preperitoneal space (one on each side near the anterior axillary line). Placement of the catheters was lateral to all planned trocar insertion sites and inferior to the costal margin. Before placing any of the working trocars, 5 mL of 1% lidocaine were injected through each catheter, a cap was placed, and the catheter was secured with a steri-strip. At the completion of the case, an additional 10 mL of 1% lidocaine were injected into each catheter. The catheters were secured with iodine-impregnated Tegaderm and the pain pump was attached to the catheters before the patient leaving the OR. The initial setting was 7 mL/hr in each catheter. Hospital course After the operation, patients were started on a hydromorphone PCA at a rate of .2 mg every 10 minutes. This was adjusted as necessary to keep a patient’s pain controlled. Patients remained nothing per os (NPO) and were given intravenous (IV) fluids and IV antiemetic. Antiemetics started at standard dose of 4 mg ondansetron and other antiemetics were added if needed. All patients were expected to walk on the day of surgery, and a note was made if the patient failed to walk on the operative day. Patients were also expected to void within 8 hours postoperatively, since a Foley was routinely used during the case. On the morning of postoperative day (POD) 1, the PCA was stopped, narcotic elixir and oral meds were initiated, and patients started drinking 30 cc of water every 15 minutes. Break through pain was treated with IV narcotics as needed. Provided patients were tolerating water, they were advanced to full liquids in the late morning of POD 1. Patients were discharged home when pain was controlled with oral narcotic medication, nausea was controlled with oral antiemetics, and patients were drinking sufficient fluids to prevent dehydration. Patients were given the option of removing CIC at discharge or removing the CIC at home when empty. Study outcomes Patient demographic characteristics to include gender, age, race, and BMI before surgery were recorded. Main endpoints were narcotic usage in morphine equivalents (ME), ondansetron usage (mg), promethazine usage (mg),
Pain catheter usage in laparoscopic sleeve gastrectomies / Surgery for Obesity and Related Diseases ] (2015) 00–00
metoclopramide usage (mg), PCA attempts, and total hospital time. Postoperative pain was recorded at 4 hour intervals using a 10 point Likert scale with 0 being no pain and 10 being severe pain. Also recorded were adverse events to include urinary retention, ileus, and hypoxia. Data collection concluded upon discharge from the hospital. Analysis After meeting with a statistician, we examined previous studies that reported a statistically significant difference in narcotics usage. We then averaged the difference detected in those studies, which yielded a result of 52 mg morphine equivalents. A power analysis then determined that a group size of 51 participants in each arm would yield 80% power to detect a 52-mg difference in morphine equivalents during the hospital stay. The study was stopped 20 patients short of full enrollment when an interim analysis determined the difference between the 2 groups was only 6 mg ME. To detect a statistically significant difference this small, each arm would require 4500 patients in each arm, which was not feasible at our institution. After unblinding, ANOVA and regression tests were used to compare mean endpoints between the placebo and the ropivacaine groups. Analysis of covariance was used to assess the relationship between BMI, age, and race with the previously mentioned endpoints.
3
Table 2 Endpoints Parameter
Placebo
Confidence interval
Ropivacaine
Confidence interval
P
Total narcotic (ME) PCA attempts Ondansetron (mg) Promethazine (mg) Hospital time (hr)
55.2
45.2–65.1
51.8
41.6–62.0
.63
73.7 10.6
44.1–103.4 7.6–13.6
62.0 10.7
29.2–94.8 7.7–13.6
.59 .98
6.8
3.4–10.3
11.7
6.7–16.7
.10
38.2
35.0–41.4
37.5
33.5–41.4
.77
ME ¼ morphine equivalents; PCA ¼ patient-controlled analgesia.
82 patients were enrolled in the study, with 43 in the placebo group and 39 in the ropivacaine group. The average BMI of all patients was 42.3 kg/m2 with an average age of 34.9 years. There was no significant difference between the 2 groups with regards to age, BMI, or race (Table 1). The total narcotic usage throughout the hospital stay was 55.2 ⫾ 32.4 ME for the placebo group and 51.8 ⫾ 31.6 ME for the ropivacaine group (P ¼ .63). There was no difference in the average PCA attempts between the 2 groups. Ondansetron usage was nearly identical between the 2 groups (10.6 mg placebo versus 10.7 mg ropivacaine;
P ¼ .96). Promethazine usage was 6.8 mg for placebo versus 11.7 mg for the ropivacaine group, P ¼ .1. Hospital length of stay, measured from the time of postanesthesia care unit (PACU) admission until the time of discharge order was also similar between 2 groups (38.2 hrs placebo versus 37.5 hrs ropivacaine P ¼ .77). None of these findings were statistically significant (Table 2). There was no statistically significant difference in pain scores at any time during the postoperative course. The average pain score throughout the hospital stay was 3.0 in both groups. No pain score differences at any of the various time points were statistically significant, though at time 0, the ropivacaine group had higher scores at 4.1 compared to 3.6 (P ¼ .51), and at time 32 hrs, the placebo group had higher scores at 3.6 compared to 2.7 (P ¼ .34) (Table 3). With regard to adverse events, the placebo group had 1 case of urinary retention and the ropivacaine group had 2 cases of urinary retention, though this was not statistically significant (P ¼ .46). One patient in the ropivacaine group had an episode of anterior thigh numbness, which resolved when the pain pump was decreased from 7 cc/hr to 4 cc/hr. There were no cases of ileus or hypoxia in either group. All patients walked on the day of surgery. When comparing patient demographic characteristics, without considering CIC content, older patients (450 yrs old) tended to use fewer narcotics (P ¼ .02) and had lower
Table 1 Demographic characteristics
Table 3 Pain score
Results
Parameter (n)
Placebo (43)
Ropivacaine (39)
Total (82)
Age (yr) BMI (kg/m2) Gender Male Female Race White Black Hispanic Asian
33.9 42.8
35.9 42.2
34.9 42.5
3 (7%) 40
3 (7%) 36
6 (7%) 76
21 (49%) 10 (23%) 10 (23%) 2 (5%)
22 (56%) 8 (21%) 8 (21%) 1 (2%)
43 (52%) 18 (22%) 18 (22%) 3 (4%)
BMI ¼ body mass index.
P .37 .64
Parameter Placebo (hr postop) Pain avg 0 4 8 12 16 20 24 28 32
3.0 3.6 3.9 2.9 2.5 2.4 2.7 3.4 3.3 3.6
Confidence interval 2.4–3.5 2.5–4.7
1.7–3.3
2.7–4.2
Ropivacaine 3.0 4.1 3.8 2.7 2.6 2.8 3.1 3.5 3.0 2.7
Confidence interval
P
2.5–3.5 3.1–5.2
.96 .51
1.6–3.6
.9
2.6–4.4
.9 .34
4
E. M. Cleveland et al. / Surgery for Obesity and Related Diseases ] (2015) 00–00
pain scores (P ¼ .02). Additionally, Blacks tended to use less narcotics as well (P ¼ .02). Discussion This is the first prospective randomized, double-blind controlled trial done in laparoscopic bariatric procedures regarding the use of CIC. This is also the first study done regarding LSG and the use of CIC. In our study, we found no significant difference between the ropivacaine and the placebo group regarding narcotic usage, antiemetic usage, pain scores, length of hospital stay, or PCA attempts. The ropivacaine and the placebo groups were similar in their demographic composition with near identical average age and average BMI. The difference in narcotic usage between the ropivacaine and placebo groups was 3.4 ME. 3.4 ME is equivalent to .5 mg of hydromorphone, which costs about $2 for a 2 mg ampule. This minimal difference in narcotic usage does not justify a $700 cost increase to use the CIC. The ondansetron usage in both groups was virtually identical (.1 mg different), and promethazine usage was higher in the ropivacaine group, though neither was statistically significant. This similarity is not surprising given previous papers, in favor of the CIC, have attributed the decreased usage of antiemetics to the decreased usage of narcotic medications, which we did not find in this study. While there were minimal complications in both groups, the ropivacaine group did have a higher number of episodes of urinary retention (2), compared to the placebo group (1), though this was not statistically significant. There were no episodes of ileus or hypoxia in either group. Interestingly, 4 of 82 patients (2 in each group) asked that the pain ball be removed early because it was bothersome or the catheters were leaking. Our results mirror the results of other nonbariatric laparoscopic cases [21,22], in that there was no significant difference in opioid usage, antiemetic usage, pain scores, hospital stay, or adverse outcomes. Also, all patients in both groups ambulated on POD 0 and were able to transition to the bariatric protocol currently being utilized at our hospital on POD 1. After completing this study, our institution discontinued the use of CIC for all bariatric surgeries. This change in practice was performed because the cost of the CIC was not justified without a proven clinical benefit. The limitations of this study include that it is a single institution where many of the patients were younger, relatively healthy, and female, which may not represent the national bariatric population. Additionally, this was done at a government facility with different financial constraints compared to privately owned hospitals. That being said, we believe the bariatric experience at our institution is similar to other bariatric programs and our results are widely applicable. Also, the study was stopped short when an interim analysis indicated a minimal
difference in the 2 groups and that enrolling an additional 20 patients would not alter the results. Additionally, we did not include an arm without catheters, as we wanted to allow for the placebo effect to maintain the blinded nature of the study. Finally, the total narcotic usage in our study is less than in other studies, which may suggest some other difference that we did not account for [17]. Conclusions In an LSG, the use of CIC does not significantly decrease the use of narcotics, number of PCA attempts, use of antiemetics, hospital length of stay, or pain scores. Omitting the use of CIC may save hospital resources. Disclosures The authors have no commercial associations that might be a conflict of interest in relation to this article. References [1] Baig MK, Zmora O, Derdemezi J, Weiss EG, Nogueras JJ, Wexber SD. Use of the On-Q pain management system is associated with decreased postoperative analgesic requirement: Double blind randomized placebo pilot trial. JACS 2006;202:297–305. [2] Schurr MJ, Gordon DB, Pellino TA, Scanlon TA. Continuous local anesthetic infusion for pain management after outpatient inguinal herniorrhaphy. J Surg 2004;136:761–9. [3] Bertoglio S, Fabiana F, DeNegri P, et al. The postoperative analgesic efficacy of preperitoneal continuous wound infusion compared to epidural continuous infusion with local anesthetics after colorectal cancer surgery: a randomized controlled multicenter study. Anesth Analg 2012;115:1442–50. [4] Liu SS, Richman JM, Thirlby RC, Wu CL. Efficacy of continuous wound catheters delivering local anesthetic for postoperative analgesia: a quantitative and qualitative review of randomized controlled trials. JACS 2006;203,6:914–32. [5] Beaussier M, El’Ayoubi H, Schiffer E, et al. Continuous preperitoneal infusion of ropivacaine provides effective analgesia and accelerates recovery after colorectal surgery. Anesthesiology 2007;107:461–8. [6] Polglase AL, McMurrick PJ, Simpson PJ, et al. Continuous wound infusion of local anesthetic for the control of pain after elective abdominal colorectal surgery. Dis Colon Rectum 2007;50:2158–67. [7] Wang LW, Wong SW, Crowe PJ, et al. Wound infusion with local anesthesia after laparotomy: a randomized controlled trial. ANZ J Surg 2010;80:794–801. [8] LeBlanc KA, Bellanger D, Rhynes VK, Hausmann M. Evaluation of a continuous infusion of 0.5% Marcaine via elastomeric pump for postoperative pain management following open inguinal hernia repair. JACS 2005;200:198–202. [9] Gupta A, Perniola A, Axelsson K, Thorn SE, Crafoord K, Rawal N. Postoperative pain after abdominal hysterectomy: a double blind comparison between placebo and local anesthetic infused intraperitoneally. Anes Analg 2004;99:1173–9. [10] Wheatly GH, Rosenbaum DH, Paul MC, et al. Improved pain management outcomes with continuous infusion of a local anesthetic after thoracotomy. J Thorac Cardiovasc Surg 2005;130:464–8. [11] Dowling R, Thielmeier K, Ghaly A, Barber D, Boice T, Dine A. Improved pain control after cardiac surgery: results of a randomized double blind clinical trial. J Thorac Cardiovasc Surg 2003;126: 1271–8.
Pain catheter usage in laparoscopic sleeve gastrectomies / Surgery for Obesity and Related Diseases ] (2015) 00–00 [12] Singh K, Samartzis D, Strom J, et al. A prospective randomized double blind study evaluating the efficacy of postoperative continuous local anesthetic infusion at the iliac crest bone graft site after spinal arthrodesis. Spine 2005;30:2477–83. [13] Gottschalk A, Burmeister MA, Radtke P, et al. Continuous wound infiltration with ropivacaine reduces pain and analgesic requirement after shoulder surgery. Anesth Analg 2003;97:1086–91. [14] Zimberg S.E. Reducing pain and costs with innovative postoperative pain management. Manag Care Q 2003 Winter;11:34–36. [15] Rosen MJ, Duperier T, Marks J, et al. Prospective randomized double blinded placebo controlled trial of postoperative elastomeric pain pump devices used after laparoscopic ventral hernia repair. Surg Endos 2009;23:2637–43. [16] Iyer CP, Robertson BD, Lenkovsky F, Huerta S, Livingston E, Thurmon JJ. Gastric bypass and On-Q pump: effectiveness of soaker catheter system on recovery of bariatric patients. SOARD 2010;6:181–4. [17] Cohen AR, Smith AN, Henriksen BS. Postoperative opioid requirements following roux en y gastric bypass in patients receiving
[18]
[19] [20]
[21]
[22]
5
continuous bupivacaine through a pump system: a retrospective review. Hosp Pharm 2013;48:479–83. Rosenthal RJ. International sleeve gastrectomy expert panel consensus statement: best practice guidelines based on experience of 4 12,000 cases. SOARD 2012;8:8–19. D Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2008. Obes Surg 2009;19:1605–11. Sanchez B, Waxman K, Tatevossian R, Gamberdella M, Read B. Local anesthetic infusion pumps improve post operative pain after inguinal hernia repair: a randomized trial. Am Surg 2004;70:1002–6. Sherwinter DA, Ghaaznavi AM, Spinner D, Savel RH, Macura JM, Adler H. Continuous infusion of intraperitoneal bupivacaine after laparoscopic surgery: a randomized controlled trial. Obes Surg 2008;18:1581–6. Cottam DR, Fisher B, Atkinson J, et al. A randomized trial of bupivacaine pain pumps to eliminate the need for patient controlled analgesia pumps in primary laparoscopic Roux-en-Y gastric bypass. Obes Surg 2007;17:595–600.
Original article
Prospective randomized double-blind controlled trial of continuous local anesthetic infusion to reduce narcotic use in laparoscopic sleeve gastrectomy Elaine M. Cleveland, M.D.*, Gregory S. Peirce, M.D., Josiah D. Freemyer, M.D., John P. Schriver, M.D., Eric P. Ahnfeldt, D.O., William V. Rice, M.D. General Surgery Department, William Beaumont Army Medical Center, El Paso, Texas. Received October 3, 2014; accepted December 27, 2014
Abstract
Background: In an era of cost containment and outcome-based medicine, bariatric surgeons are attempting to decrease perioperative morbidity and streamline care. One way of accomplishing this is by decreasing opioid use and hospital stay. Several studies of nonbariatric open procedures have shown that continuous infusion catheters (CIC) are beneficial. Bariatric surgeons frequently utilize CIC, but the data is sparse for the clinical efficacy in laparoscopic procedures. Objective: Evaluate the efficacy of CIC in laparoscopic sleeve gastrectomy. Setting: military teaching hospital. Methods: In this single institution prospective randomized double-blind controlled study, 82 patients undergoing laparoscopic sleeve gastrectomy (LSG) received either .2% ropivacaine or .9% normal saline (placebo) via CIC. After discharge, total narcotic usage, total antiemetic usage, pain scores, and hospital length of stay were evaluated. A one-way ANOVA was used to assess statistical significance. Power was 80% to detect 52 mg morphine equivalent difference. Results: A total of 82 patients were enrolled, 39 received ropivacaine, and 43 received placebo. There was no statistically significant difference in narcotic usage between the ropivacaine group and placebo group, 51.9 mg versus 55.2 mg, respectively (P ¼ .63). Ondansetron usage was 10.7 mg and 10.6 mg for ropivacaine and placebo groups. (P ¼ .98). Average pain score was 3.0 for each group (P ¼ .632). Total hospital length of stay was 37.5 hours for ropivacaine group and 38.1 hours for placebo group (P ¼ .768). Conclusions: We found no difference in narcotic usage, antiemetic usage, pain scores, or hospital length of stay between ropivacaine and placebo groups. We conclude there is no utility of CIC in LSG. (Surg Obes Relat Dis 2015;]:00–00.) Published by Elsevier Inc. on behalf of American Society for Metabolic and Bariatric Surgery.
Keywords:
Continuous infusion catheters; Laparoscopic sleeve gastrectomy; Narcotic usage
Constant scrutiny of costs while maintaining quality care is omnipresent in the delivery of healthcare today. Continuous infusion catheters (CIC) for postoperative pain management have been shown to reduce the following: narcotic usage [1], time until ambulation, pain scores [2], time to return of bowel function [3], postoperative nausea, *
Correspondence: Elaine Cleveland, 5005 N Piedras Dr, El Paso, TX 79920. Tel.: þ915 742 2698; fax: þ915 742 7889. E-mail: [email protected]
and vomiting. CIC have also been shown to increase patient satisfaction scores [4]. However, these benefits were realized in studies evaluating open colectomy [5,6], laparotomy [7], open inguinal hernia repair [8], hysterectomy [9], thoracotomy[10], sternotomy [11], orthopedic procedures [12,13], and a multivariate analysis of multiple different surgical procedures [4,14]. Despite the increasing number of bariatric procedures being performed, there is a comparative shortage of literature regarding CIC in bariatric surgery [15,16]. A
http://dx.doi.org/10.1016/j.soard.2014.12.030 1550-7289/Published by Elsevier Inc. on behalf of American Society for Metabolic and Bariatric Surgery.
2
E. M. Cleveland et al. / Surgery for Obesity and Related Diseases ] (2015) 00–00
retrospective review from 2013 showed decreased narcotic usage in laparoscopic Roux-en-Y Gastric Bypass (LRYGB) patients receiving CIC analgesia compared to those without the catheter [17]. Laparoscopic sleeve gastrectomy (LSG) is becoming more popular due to perceived technical simplicity, feasibility, and good patient outcomes with regard to weight loss and improvement in co-morbidities [18,19]. Many bariatric surgery centers implement protocols to treat LSG patients similar to LRYGB patients, even with regards to postoperative pain management. However, LSG patients have less manipulation of the bowel, fewer ports, and shorter operative times. The CIC are not without their own cost and complications. At our hospital, the ropivacaine filled pain pump costs $284 and the bariatric catheter insertion set costs $426, equaling $710 per patient. Placement of the CIC can lengthen operative time, cause skin irritation, or cause infection [20]. The purpose of our study was to determine if CIC were effective in improving the following parameters: opioid usage, antiemetic usage, patient controlled analgesia (PCA) attempts, hospital stay, and pain scores in the peri-operative period following a LSG. We also tracked adverse events such as urinary retention and hypoxic episodes to determine if there was any difference between the 2 groups. Our aim was to determine if there was a difference in these parameters. If no difference existed, the CIC would be discontinued, thus decreasing the cost of LSG without compromising care. Methods After Institutional Review Board approval, patients were enrolled at a single institution from January 2013 until April 2014. Patients were recruited from those that qualified for bariatric surgery (418 years, body mass index (BMI) 440 or 435 with co-morbidities, attempt at previous weight loss, psychiatric clearance, and meeting with a nutritionist) and were to undergo LSG with standard 4 port placement as an initial bariatric procedure. All patients meeting the above criteria, including those with chronic pain and chronic opioid use, were eligible for inclusion. A research resident would enroll patients and send the patient demographic characteristics and consent to the pharmacy. Exclusion criteria included revision surgery, single-incision surgery, and history of allergy to local anesthetic. There were 4 different attending surgeons who followed the same methodology for LSG. Two surgeons did 60% of cases while the other 2 did the remaining 40%. Residents ranging in experience from postgraduate year (PGY) PGY-1 to PGY-5 were involved in the operation as well as the perioperative care. The pharmacist randomized patients using a coin flip and then filled the 600 cc elastometric pump with either .9%
injectable normal saline or .2% ropivacaine. The pump was labeled with patient identification, and was distributed to the operating room before the start of the procedure. The content of the CIC was not known by the patient, the operating surgeons, nurses, or the data collectors until completion of data analysis. Placement of the catheter After gaining laparoscopic access to the abdomen with an optical viewing trocar, 2 continuous infusion catheters (20 ga) were placed percutaneously under direct visualization into the preperitoneal space (one on each side near the anterior axillary line). Placement of the catheters was lateral to all planned trocar insertion sites and inferior to the costal margin. Before placing any of the working trocars, 5 mL of 1% lidocaine were injected through each catheter, a cap was placed, and the catheter was secured with a steri-strip. At the completion of the case, an additional 10 mL of 1% lidocaine were injected into each catheter. The catheters were secured with iodine-impregnated Tegaderm and the pain pump was attached to the catheters before the patient leaving the OR. The initial setting was 7 mL/hr in each catheter. Hospital course After the operation, patients were started on a hydromorphone PCA at a rate of .2 mg every 10 minutes. This was adjusted as necessary to keep a patient’s pain controlled. Patients remained nothing per os (NPO) and were given intravenous (IV) fluids and IV antiemetic. Antiemetics started at standard dose of 4 mg ondansetron and other antiemetics were added if needed. All patients were expected to walk on the day of surgery, and a note was made if the patient failed to walk on the operative day. Patients were also expected to void within 8 hours postoperatively, since a Foley was routinely used during the case. On the morning of postoperative day (POD) 1, the PCA was stopped, narcotic elixir and oral meds were initiated, and patients started drinking 30 cc of water every 15 minutes. Break through pain was treated with IV narcotics as needed. Provided patients were tolerating water, they were advanced to full liquids in the late morning of POD 1. Patients were discharged home when pain was controlled with oral narcotic medication, nausea was controlled with oral antiemetics, and patients were drinking sufficient fluids to prevent dehydration. Patients were given the option of removing CIC at discharge or removing the CIC at home when empty. Study outcomes Patient demographic characteristics to include gender, age, race, and BMI before surgery were recorded. Main endpoints were narcotic usage in morphine equivalents (ME), ondansetron usage (mg), promethazine usage (mg),
Pain catheter usage in laparoscopic sleeve gastrectomies / Surgery for Obesity and Related Diseases ] (2015) 00–00
metoclopramide usage (mg), PCA attempts, and total hospital time. Postoperative pain was recorded at 4 hour intervals using a 10 point Likert scale with 0 being no pain and 10 being severe pain. Also recorded were adverse events to include urinary retention, ileus, and hypoxia. Data collection concluded upon discharge from the hospital. Analysis After meeting with a statistician, we examined previous studies that reported a statistically significant difference in narcotics usage. We then averaged the difference detected in those studies, which yielded a result of 52 mg morphine equivalents. A power analysis then determined that a group size of 51 participants in each arm would yield 80% power to detect a 52-mg difference in morphine equivalents during the hospital stay. The study was stopped 20 patients short of full enrollment when an interim analysis determined the difference between the 2 groups was only 6 mg ME. To detect a statistically significant difference this small, each arm would require 4500 patients in each arm, which was not feasible at our institution. After unblinding, ANOVA and regression tests were used to compare mean endpoints between the placebo and the ropivacaine groups. Analysis of covariance was used to assess the relationship between BMI, age, and race with the previously mentioned endpoints.
3
Table 2 Endpoints Parameter
Placebo
Confidence interval
Ropivacaine
Confidence interval
P
Total narcotic (ME) PCA attempts Ondansetron (mg) Promethazine (mg) Hospital time (hr)
55.2
45.2–65.1
51.8
41.6–62.0
.63
73.7 10.6
44.1–103.4 7.6–13.6
62.0 10.7
29.2–94.8 7.7–13.6
.59 .98
6.8
3.4–10.3
11.7
6.7–16.7
.10
38.2
35.0–41.4
37.5
33.5–41.4
.77
ME ¼ morphine equivalents; PCA ¼ patient-controlled analgesia.
82 patients were enrolled in the study, with 43 in the placebo group and 39 in the ropivacaine group. The average BMI of all patients was 42.3 kg/m2 with an average age of 34.9 years. There was no significant difference between the 2 groups with regards to age, BMI, or race (Table 1). The total narcotic usage throughout the hospital stay was 55.2 ⫾ 32.4 ME for the placebo group and 51.8 ⫾ 31.6 ME for the ropivacaine group (P ¼ .63). There was no difference in the average PCA attempts between the 2 groups. Ondansetron usage was nearly identical between the 2 groups (10.6 mg placebo versus 10.7 mg ropivacaine;
P ¼ .96). Promethazine usage was 6.8 mg for placebo versus 11.7 mg for the ropivacaine group, P ¼ .1. Hospital length of stay, measured from the time of postanesthesia care unit (PACU) admission until the time of discharge order was also similar between 2 groups (38.2 hrs placebo versus 37.5 hrs ropivacaine P ¼ .77). None of these findings were statistically significant (Table 2). There was no statistically significant difference in pain scores at any time during the postoperative course. The average pain score throughout the hospital stay was 3.0 in both groups. No pain score differences at any of the various time points were statistically significant, though at time 0, the ropivacaine group had higher scores at 4.1 compared to 3.6 (P ¼ .51), and at time 32 hrs, the placebo group had higher scores at 3.6 compared to 2.7 (P ¼ .34) (Table 3). With regard to adverse events, the placebo group had 1 case of urinary retention and the ropivacaine group had 2 cases of urinary retention, though this was not statistically significant (P ¼ .46). One patient in the ropivacaine group had an episode of anterior thigh numbness, which resolved when the pain pump was decreased from 7 cc/hr to 4 cc/hr. There were no cases of ileus or hypoxia in either group. All patients walked on the day of surgery. When comparing patient demographic characteristics, without considering CIC content, older patients (450 yrs old) tended to use fewer narcotics (P ¼ .02) and had lower
Table 1 Demographic characteristics
Table 3 Pain score
Results
Parameter (n)
Placebo (43)
Ropivacaine (39)
Total (82)
Age (yr) BMI (kg/m2) Gender Male Female Race White Black Hispanic Asian
33.9 42.8
35.9 42.2
34.9 42.5
3 (7%) 40
3 (7%) 36
6 (7%) 76
21 (49%) 10 (23%) 10 (23%) 2 (5%)
22 (56%) 8 (21%) 8 (21%) 1 (2%)
43 (52%) 18 (22%) 18 (22%) 3 (4%)
BMI ¼ body mass index.
P .37 .64
Parameter Placebo (hr postop) Pain avg 0 4 8 12 16 20 24 28 32
3.0 3.6 3.9 2.9 2.5 2.4 2.7 3.4 3.3 3.6
Confidence interval 2.4–3.5 2.5–4.7
1.7–3.3
2.7–4.2
Ropivacaine 3.0 4.1 3.8 2.7 2.6 2.8 3.1 3.5 3.0 2.7
Confidence interval
P
2.5–3.5 3.1–5.2
.96 .51
1.6–3.6
.9
2.6–4.4
.9 .34
4
E. M. Cleveland et al. / Surgery for Obesity and Related Diseases ] (2015) 00–00
pain scores (P ¼ .02). Additionally, Blacks tended to use less narcotics as well (P ¼ .02). Discussion This is the first prospective randomized, double-blind controlled trial done in laparoscopic bariatric procedures regarding the use of CIC. This is also the first study done regarding LSG and the use of CIC. In our study, we found no significant difference between the ropivacaine and the placebo group regarding narcotic usage, antiemetic usage, pain scores, length of hospital stay, or PCA attempts. The ropivacaine and the placebo groups were similar in their demographic composition with near identical average age and average BMI. The difference in narcotic usage between the ropivacaine and placebo groups was 3.4 ME. 3.4 ME is equivalent to .5 mg of hydromorphone, which costs about $2 for a 2 mg ampule. This minimal difference in narcotic usage does not justify a $700 cost increase to use the CIC. The ondansetron usage in both groups was virtually identical (.1 mg different), and promethazine usage was higher in the ropivacaine group, though neither was statistically significant. This similarity is not surprising given previous papers, in favor of the CIC, have attributed the decreased usage of antiemetics to the decreased usage of narcotic medications, which we did not find in this study. While there were minimal complications in both groups, the ropivacaine group did have a higher number of episodes of urinary retention (2), compared to the placebo group (1), though this was not statistically significant. There were no episodes of ileus or hypoxia in either group. Interestingly, 4 of 82 patients (2 in each group) asked that the pain ball be removed early because it was bothersome or the catheters were leaking. Our results mirror the results of other nonbariatric laparoscopic cases [21,22], in that there was no significant difference in opioid usage, antiemetic usage, pain scores, hospital stay, or adverse outcomes. Also, all patients in both groups ambulated on POD 0 and were able to transition to the bariatric protocol currently being utilized at our hospital on POD 1. After completing this study, our institution discontinued the use of CIC for all bariatric surgeries. This change in practice was performed because the cost of the CIC was not justified without a proven clinical benefit. The limitations of this study include that it is a single institution where many of the patients were younger, relatively healthy, and female, which may not represent the national bariatric population. Additionally, this was done at a government facility with different financial constraints compared to privately owned hospitals. That being said, we believe the bariatric experience at our institution is similar to other bariatric programs and our results are widely applicable. Also, the study was stopped short when an interim analysis indicated a minimal
difference in the 2 groups and that enrolling an additional 20 patients would not alter the results. Additionally, we did not include an arm without catheters, as we wanted to allow for the placebo effect to maintain the blinded nature of the study. Finally, the total narcotic usage in our study is less than in other studies, which may suggest some other difference that we did not account for [17]. Conclusions In an LSG, the use of CIC does not significantly decrease the use of narcotics, number of PCA attempts, use of antiemetics, hospital length of stay, or pain scores. Omitting the use of CIC may save hospital resources. Disclosures The authors have no commercial associations that might be a conflict of interest in relation to this article. References [1] Baig MK, Zmora O, Derdemezi J, Weiss EG, Nogueras JJ, Wexber SD. Use of the On-Q pain management system is associated with decreased postoperative analgesic requirement: Double blind randomized placebo pilot trial. JACS 2006;202:297–305. [2] Schurr MJ, Gordon DB, Pellino TA, Scanlon TA. Continuous local anesthetic infusion for pain management after outpatient inguinal herniorrhaphy. J Surg 2004;136:761–9. [3] Bertoglio S, Fabiana F, DeNegri P, et al. The postoperative analgesic efficacy of preperitoneal continuous wound infusion compared to epidural continuous infusion with local anesthetics after colorectal cancer surgery: a randomized controlled multicenter study. Anesth Analg 2012;115:1442–50. [4] Liu SS, Richman JM, Thirlby RC, Wu CL. Efficacy of continuous wound catheters delivering local anesthetic for postoperative analgesia: a quantitative and qualitative review of randomized controlled trials. JACS 2006;203,6:914–32. [5] Beaussier M, El’Ayoubi H, Schiffer E, et al. Continuous preperitoneal infusion of ropivacaine provides effective analgesia and accelerates recovery after colorectal surgery. Anesthesiology 2007;107:461–8. [6] Polglase AL, McMurrick PJ, Simpson PJ, et al. Continuous wound infusion of local anesthetic for the control of pain after elective abdominal colorectal surgery. Dis Colon Rectum 2007;50:2158–67. [7] Wang LW, Wong SW, Crowe PJ, et al. Wound infusion with local anesthesia after laparotomy: a randomized controlled trial. ANZ J Surg 2010;80:794–801. [8] LeBlanc KA, Bellanger D, Rhynes VK, Hausmann M. Evaluation of a continuous infusion of 0.5% Marcaine via elastomeric pump for postoperative pain management following open inguinal hernia repair. JACS 2005;200:198–202. [9] Gupta A, Perniola A, Axelsson K, Thorn SE, Crafoord K, Rawal N. Postoperative pain after abdominal hysterectomy: a double blind comparison between placebo and local anesthetic infused intraperitoneally. Anes Analg 2004;99:1173–9. [10] Wheatly GH, Rosenbaum DH, Paul MC, et al. Improved pain management outcomes with continuous infusion of a local anesthetic after thoracotomy. J Thorac Cardiovasc Surg 2005;130:464–8. [11] Dowling R, Thielmeier K, Ghaly A, Barber D, Boice T, Dine A. Improved pain control after cardiac surgery: results of a randomized double blind clinical trial. J Thorac Cardiovasc Surg 2003;126: 1271–8.
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