Contraception 90 (2014) 594 – 600

Original research article

Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial☆,☆☆,★ Rebecca J. Mercier a,⁎, Abigail Liberty b a

Department of Obstetrics and Gynecology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, PA, USA b University of North Carolina School of Medicine, Chapel Hill, NC, USA Received 26 March 2014; revised 13 July 2014; accepted 16 July 2014

Abstract Objective: To determine if intrauterine administration of 5 cc of 2% lidocaine in addition to paracervical block reduces pain during laminaria insertion, when compared with paracervical block and saline placebo. Study Design: This was a randomized, double blind placebo-controlled trial. Women presenting for abortion by dilation and evacuation (D&E) at 14–24 weeks gestational age were randomized to receive an intrauterine instillation of either 5 mL of 2% lidocaine or 5 mL of normal saline, in addition to standard paracervical block with 20 cc of 0.25% bupivacaine. Our primary outcome was self-reported pain scores on a 100 mm Visual Analogue Scale (VAS) immediately following laminaria insertion. Secondary outcome was self-reported VAS pain score indicating the maximum level of pain experienced during the 24–48-h interval between laminaria insertion and D&E procedure. Results: Seventy-two women were enrolled, and data for 67 women were analyzed, only two of whom were more than 21 weeks on gestation. The range of pain scores at both time points was large (1–90 mm at laminaria insertion; 0–100 mm in laminaria–D&E interval). Mean pain scores were not different between treatment groups at laminaria insertion, (33 vs. 32, p=.8) or in the laminaria – D&E interval (43 vs. 44, p=.9). Conclusion: Intrauterine administration of 5 cc of 2% lidocaine in addition to paracervical block did not reduce pain with laminaria insertion when compared to paracervical block with saline placebo. Implications: Intrauterine lidocaine combined with paracervical block does not improve pain control at laminaria insertion when compared with paracervical block and saline placebo. Wide variation in pain scores and persistent pain after laminaria insertion suggests patient would benefit from more effective methods of pain control at laminaria insertion and during the post-laminaria interval. © 2014 Elsevier Inc. All rights reserved. Keywords: Abortion; Dilation and evacuation; Cervical preparation; Anesthesia

1. Introduction Second trimester abortion by dilation and evacuation (D&E) requires greater cervical dilation than first trimester ☆ Funding: This study received financial support from the Department of Obstetrics and Gynecology at University of North Carolina Chapel Hill. The corresponding author was supported by an National Institutes of Health T-32 grant for clinical research (Grant #T32 HD 40672–11) and the North Carolina Translational and Clinical Sciences Institute. The Institute is supported by grants UL1RR025747, KL2RR025746, and TLRR025745 from the NIH National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health. ☆☆ Neither author reports any potential financial or other conflict of interest. ★ Clinical Trial Registration: ClinicalTrials.gov (NCT01541293). ⁎ Corresponding author. Department of Obstetrics and Gynecology, Jefferson Medical College, 833 Chestnut Street Philadelphia PA 19107. Tel.: + 1 917 627 3494. E-mail address: [email protected] (R.J. Mercier).

http://dx.doi.org/10.1016/j.contraception.2014.07.008 0010-7824/© 2014 Elsevier Inc. All rights reserved.

procedures; to improve safety the dilation is commonly done by placement of osmotic dilators such as laminaria one or two days before the D&E procedure [1–3]. Many women find laminaria placement painful if no anesthesia is used [4,5]; several studies have reported that the procedure may be associated with moderate to severe pain even when cervical or paracervical block is performed [6–8]. While multiple studies have evaluated various methods for controlling pain in abortion procedures [9], no studies to date have specifically evaluated different methods of pain control for laminaria insertion. Innervation of the uterus is complex. Pain from the cervix and lower uterine segment is largely conducted via the uterovaginal plexus to the inferior hypogastric plexus. However, some of the pain fibers from the uterine body may enter the hypogastric plexus at a level superior to the utero-vaginal junction [10,11]; additional afferent pain fibers from the

R.J. Mercier, A. Liberty / Contraception 90 (2014) 594–600

uterine body may be carried along with the autonomic nerves which travel with the ovarian plexus[11]. While paracervical block can effectively control pain as conducted by the uterovaginal plexus, additional procedure-related pain may be mediated by these other pathways which are unaffected by paracervical block. Pain control during gynecologic procedures may be improved by incorporating adjunctive techniques such as intrauterine instillation of local anesthetic agents which could provide anesthesia at these sites [12–14]. Several studies have shown that instillation of 5–10 mL of 1%, 2% or 4% lidocaine into the cervical canal and uterine cavity may produce clinically and statistically significant reductions in pain scores in endometrial biopsy [15–17], fractional curettage [18,19] hysteroscopy [20], saline infusion sonograms [21] and first trimester abortion [22]. In these studies, authors have shown reduction in pain during both uterine cavity instrumentation and cervical dilation and manipulation [19,22]. Much of the pain of laminaria insertion is related to cervical manipulation, and is predominantly mediated by the lower plexus. That moderate to severe pain is frequently reported with laminaria insertion even when paracervical block is used suggests that these other innervation pathways may also be involved in procedure-related pain. Given the effectiveness of intrauterine anesthetic in other procedures, we hypothesized that it could be effective in controlling pain associated with laminaria insertion as well. We performed a randomized clinical trial to evaluate the effectiveness of intrauterine anesthesia plus paracervical block in improving pain scores during laminaria insertion when compared with saline placebo and paracervical block.

2. Materials and methods This study was performed in the Family Planning clinic of the University of North Carolina at Chapel Hill from April 2012 to November 2013. Study participation was offered to patients with singleton or multiple pregnancies between 14 and 24 weeks of gestation presenting to the clinic for elective outpatient abortion by D&E. Women were eligible for enrollment if they were over 18 years of age, English speaking, weighed over 45 kg, had no contraindications to receiving lidocaine, and were expected to have D&E completed within 48 h after laminaria insertion. Women undergoing D&E for rupture of membranes or infection were not eligible for this study. Standard practice at our clinic is to perform D&E 48 h after laminaria insertion, though occasionally D&E procedures are scheduled to be completed earlier, typically 24 h after laminaria insertion, if a patient's individual circumstances require expedited care. The study was approved by the institutional review board (IRB) of the University of North Carolina at Chapel Hill and registered at ClinicalTrials.gov (NCT01541293). Patients were approached by research staff regarding the study after standard surgical consent for D&E was completed. After study enrollment and informed consent,

595

participants were randomized in a 1:1 ratio to receive an intrauterine instillation of either 5 mL of 2% lidocaine or 5 mL of normal saline as placebo. Both participants and providers were blinded to treatment. Randomization was accomplished with a computer generated block randomization scheme using randomly permutated blocks of four, six and eight. The randomization sequence document was generated prior to study initiation by a member of the research team not involved in participant enrollment or care. The randomization document indicated treatment arm “placebo” or “lidocaine” for each sequential participant number. The randomization document was held by the institutional Investigational Drug Services (IDS) pharmacy. Research staff involved in patient care did not have access to the randomization sequence at any time during the study. After participant enrollment, the IDS pharmacist would note the treatment arm assignment for that sequential participant number; the IDS pharmacist then prepared the appropriate study medication. The medication was dispensed to a research staff member in a syringe labeled only with the study ID number. The syringes containing either lidocaine or placebo which were handled by the study staff were visually identical. All participants underwent laminaria insertion using standard clinical practices. After speculum insertion, the cervix was cleaned with betadine solution. One cc of 0.25% bupivicaine was injected into the anterior lip of the cervix. The anterior lip of the cervix was grasped with a single tooth tenaculum. Paracervical block using 19 cc of 0.25% bupivicaine was then placed by injection at the 8-o'clock and 4-o'clock positions at a depth of approximately 1 cm. The study medication was then instilled into the cervical canal using a Uterine Explora catheter (Cooper Surgical MX 130 Model 2 – uterine biopsy pipelle with a luer lock for syringe attachment). The catheter was inserted to the internal os of the cervix and the medication was administered with a slow push over 30 s, instilling the medication into the uterus just above the internal os. The catheter was held in place for 60 s after completed push to prevent backflow from the cervical os. The catheter was removed and the laminaria insertion was completed. All laminaria were placed by an attending physician, family planning fellow, or senior resident. Three attending physicians, three fellows and seven residents were involved in the clinical care in the study. The total number of laminaria inserted was determined by the gestational age and clinical judgment. The goal for all participants was placement of the maximum number of laminaria and serial insertion continued until the supervising attending concurred that no further laminaria could be safely placed. Participants were instructed to take 600 mg ibuprofen as needed for pain at home following the insertion. Our primary outcome was participant self-report of pain score on a 100 mm visual analogue scale (VAS) immediately following the procedure (0=no pain; 100=worst pain imaginable). All pain scores were recorded within 2 min of

596

R.J. Mercier, A. Liberty / Contraception 90 (2014) 594–600

completion of the laminaria insertion and speculum removal. Our secondary outcome was participant self-report of maximum pain experienced during the 24–48-h interval post laminaria insertion and prior to D&E. Secondary pain scores were reported in the pre-operative area approximately 30 min prior to D&E; participants were asked to indicate the highest level of pain they recalled experiencing in the interval between leaving the clinic and presenting to the hospital that morning [23,24]. Studies of patient pain suggest that the minimum clinically significant difference in pain score on a 100 mm VAS is 13–16 mm [25–27]. Studies of laminaria insertion report mean pain scores ranging from 40 mm to 70 mm, with standard deviation of 22–23 mm [5,8,28]. Based

on these values, we calculated that a sample size of 68 would be necessary to have 80% power to detect a clinically significant 15 mm difference in pain score between treatment arms. To account for possible failed procedures and loss to follow-up, we recruited 72 women to participate in the study. Pain scores were examined to describe proportions of subjects reporting pain characterized as mild, moderate, or severe based on generally accepted cut points for the VAS scale (45–74 moderate pain; 75–100 severe pain) [29]. We used two-sample t-tests to compare the mean pain scores at laminaria insertion and in the interval prior to D&E between the lidocaine and placebo groups. We used a paired t-test to examine whether women reported greater pain with

Fig. 1. Allocation of participants.

R.J. Mercier, A. Liberty / Contraception 90 (2014) 594–600

laminaria insertion or in the pre-operative interval. A twosample t-test was used to determine if the difference in the two pain scores (procedure or interval) varied by treatment group. Scatterplots and simple regression were used to examine correlation between insertion and interval pain scores. For any data that appeared non-normal in comparison of mean and median, Wilcoxon rank sum and signed-rank tests were performed to confirm validity of results. Analysis of variance or Pearson’s correlation were used to examine whether any participant characteristic affected pain levels in the overall sample. Fisher's Exact test was used as needed to evaluate complications between groups due to low expected numbers. Data analysis was performed with STATA version 12 software (Stata, College Station, TX, USA).

3. Results Over the study period 168 women requested a D&E after 14-week gestational age. One hundred thirty-five of these women were screened for study enrollment; 24 were ineligible and 39 declined enrollment. A total of 72 women were enrolled. (Fig. 1) Two participants did not have a primary outcome recorded: one participant was unable to have any laminaria inserted due to a severe cervical stenosis, and one participant did not complete the primary pain scale. Four participants did not have the secondary outcome recorded as no study staff was available to record their interval pain score. Three subjects were enrolled when IRB approval for the study had lapsed for a two week period. At the direction of the IRB they were dropped from analysis. Therefore, 67 women were included in analysis of the primary pain outcome and 64 in analysis of the secondary pain outcome. Sensitivity analysis comparing outcomes with and without the excluded participants showed that these exclusions had no clinically or statistically significant impact on the results. Participants had a mean age of 31 years, and mean gestational age of about 18 weeks (Table 1). Only two participants had gestational age greater than 21 weeks and 6 days gestation. Treatment groups were similar with regard to age, gestational age, parity, and recent pregnancy history. Proportionally more white subjects were assigned to placebo, and more African-American subjects were assigned to lidocaine. The overall distribution of race is reflective of the population seen at this clinic. A total of six subjects were scheduled for D&E at 24 h rather than 48 h; four subjects in the lidocaine group and two in the placebo group. Sensitivity analysis comparing outcomes with and without participants who had planned D&E at 24 h rather than 48 h showed no clinically or statistically significant impact on the results. We observed a wide range in pain scores in both treatment arms, with scores at laminaria insertion ranging from 1 mm to 90 mm (mean 32 +/− 23, median=27) and scores for post-laminaria interval ranging from 0 mm to 100 mm (mean 44 +/− 30, median 37). (Fig. 2) Twenty one

597

participants (31%) reported moderate pain (N 45 mm) and three participants (4%) reported severe pain (N 75 mm) with laminaria insertion. In the post-laminaria interval, twenty seven participants (42%) reported moderate pain and 13 (20%) reported severe pain. We found no significant difference in mean pain scores reported at either time point between the lidocaine and placebo treatment arms (Table 2). Non-parametric testing confirmed no difference in median pain scores or overall distribution of pain scores between treatment groups. Mean pain scores for the postlaminaria interval appeared higher than those recorded at laminaria insertion (44 vs 32 p=.04). (Fig. 2) The difference in pain score at the two time points was not affected by treatment arm (placebo mean difference 10; lidocaine mean difference 9; p=.8). Pain scores at insertion did not correlate with interval pain scores (Pearson correlation coefficient 0.11). Linear regression of insertion and interval pain scores showed that pain score at insertion did not predict pain score during the post-laminaria interval (p=.42). We examined whether procedure or interval pain scores differed by age, race, pregnancy history, gestational age or number of laminaria inserted. Pain scores during laminaria procedure were slightly higher among participants with no prior vaginal delivery (38 vs 28; p=.07). Pain scores at laminaria insertion and in post laminaria interval did not

Table 1 Baseline characteristics of study participants Characteristic

Overall sample (n= 69)

Lidocaine group (n= 33)

Placebo group (n= 36)

Mean age(years) 30.6 (6.8) 30.0 (6.6) 32.1 (6.7) Mean gestational age 18.6 (1.8) 18.0 (1.9) 18.8 (1.7) (completed weeks) Race White 40 (58%) 15 (46%) 25 (69%) African-American 22 (32%) 14 (42%) 8 (22%) Hispanic 1 (1.5%) 0 1 (3%) Asian 5 (7%) 4 (12%) 1 (3%) Other 1 (1.5%) 0 1 (3%) Primigravid 19 (28%) 7 (21) 12 (33%) Nulliparous 28 (40%) 12 (36%) 16 (44%) No prior vaginal deliveries 33 (48%) 15 (45%) 18 (50%) Most recent pregnancy outcome⁎ Vaginal delivery 29 (58%) 14 (53%) 15 (62%) Cesarean 6 (12%) 3 (11%) 3 (12%) Induced abortion 6 (12%) 4 (15%) 2 (8%) Spontaneous abortion 8 (16%) 5 (19%) 3 (12%) Ectopic 1 (2%) 0 1 (4%) Education Some high school 5 (7%) 4 (12%) 1 (3%) Graduated high school 11 (16%) 5 (15%) 6 (16%) Some college 19 (27%) 10 (30%) 9 (25%) Graduated college 20 (29%) 10 (30%) 10 (28%) Post-college degree 14 (20%) 4 (12%) 10 (28%) Data are n(%) or mean (+/− S.D.). ⁎ % of participants with any prior pregnancy, n=26 in lidocaine group and n= 24 in placebo group.

598

R.J. Mercier, A. Liberty / Contraception 90 (2014) 594–600

Fig. 2. Distribution of pain scores at laminaria insertion and in post-laminaria interval.

differ by age, race, outcome of most recent prior pregnancy, time interval since last pregnancy, number of laminaria inserted or gestational age. There were no complications associated with laminaria insertion. The two groups did not differ in number of laminaria inserted within classes of gestational age (Table 3). There was no difference in frequency of minor side effects among the participants receiving lidocaine compared to placebo, and there were no events of severe side effects or toxicity in either group. The percentage of participants experiencing any complications was similar between the two groups.

Table 2 Pain scores at laminaria insertion and in post-laminaria interval At laminaria insertion (N= 67)⁎

Post laminaria insertion, prior to D&E (N=64)⁎⁎

Treatment Mean pain p value Treatment Mean pain p value group score (SD) group score (SD) (100 mm VAS) (100 mm VAS) Lidocaine 33 (22) (n= 36) Placebo 32 (25) (n= 34)

0.80

Lidocaine 43 (28) (n=35) Placebo 44 (33) (n=32)

0.90

⁎ Of total 72 enrolled, 5 not included: 2 participants did not have primary outcome; 3 participants dropped from analysis. ⁎⁎ Of total 72 patients enrolled, 8 not included: 5 participants did not have secondary outcome; 3 participants dropped from analysis.

4. Discussion Administration of 5 cc of 2% lidocaine into the cervical canal in combination with paracervical block did not improve pain scores during laminaria insertion when compared with saline placebo and paracervical block. The intervention also had no effect on pain scores reported during the interval between laminaria insertion and D&E procedure. There are several possible reasons why intrauterine lidocaine did not reduce pain with laminaria insertion. Laminaria insertion involves greater cervical dilation and less uterine manipulation than procedures such as hysteroscopy, endometrial biopsy or first trimester abortion. The pain of laminaria insertion may therefore be mediated primarily by the utero-vaginal plexus. In this case, methods targeting other pain receptors will not be as effective as in those other procedures. The anatomy of the pregnant uterus may also prevent anesthetic from reaching any endometrial receptors, further limiting the effectiveness of the method. Our dose of lidocaine, saline placebo and administration methods were chosen to mimic those used in prior studies showing efficacy [14,15,30]. Studies of intrauterine lidocaine in first trimester abortion have shown more effective reduction in pain with higher concentration of local anesthetic (4% rather than 2% lidocaine) [22,31]. If intrauterine lidocaine could be effective in laminaria insertion, a higher dose or concentration of intrauterine lidocaine might be required to see effect. It is also possible that placement of saline placebo itself affects pain scores, confounding our results. However the volume of

R.J. Mercier, A. Liberty / Contraception 90 (2014) 594–600 Table 3 Characteristics of laminaria insertion procedure and complications by intervention group

Number of laminaria inserted overall Number of laminaria by EGA (weeks) 14 +0–17 +6 weeks (n= 18) 18 +0–20 +6 weeks (n= 45) 21 +0–23 +6 weeks (n= 6) Minor anesthetic side effect⁎ Rupture of membranes Complaints of labor prior to D&E D&E performed prior to scheduled time⁎⁎

Lidocaine group

Placebo group

N= 33

N=36

p value

8 (2.1)

9 (2.5)

0.20

6 (1.3) 8 (2.2) 11 (2.7) 6 (18%) 1 (3%) 0 0

5 (1.5) 8 (2.4) 10 (2.9) 8 (22%) 1 (3%) 2 (5%) 4 (11%)

0.22 0.90 0.24 0.15

Mean (SD) or n (%). There were no cases of the following complications: cervical laceration, peri-operative infection, out-of-hospital abortion or major lidocaine side effect (seizure, loss of consciousness, cardiac or respiratory arrest). ⁎ Minor side effects: dizziness, periorbital numbness, metallic taste, tinnitus, palpitations. ⁎⁎ Fisher's Exact test.

saline used is small and seems unlikely to produce a significant anesthetic or irritant effect. We did note several surprising findings. The mean pain scores associated with laminaria insertion reported in our study are somewhat lower than those seen in prior studies where paracervical block was used [6,7]. Despite the low mean score, we saw a wide range of scores. One third of participants reported moderate or severe pain during the procedure, despite receiving anesthesia. This suggests that some women could benefit from more effective pain management during laminaria placement. In addition, pain scores for the interval following laminaria insertion were somewhat higher than the pain scores reported at time of laminaria insertion. Over 40% of patients reported moderate pain and 20% reported severe pain during the post-laminaria interval. There was no significant correlation between insertion and interval pain scores; women who have minimal pain during laminaria insertion may still have pain in the post-laminaria interval. This finding suggests that NSAIDs and similar pain medicine regimens may not provide adequate pain control following laminaria insertion. Practitioners who only provide NSAID should consider providing more aggressive pain management for these patients. Our study has both strengths and weaknesses. The primary strength is the study design: we conducted a double-blind, placebo-controlled trial, which should have minimized selection bias, information bias, and confounding. Weaknesses include our sample size: due to missing and excluded participants, we did not reach our planned sample size, lacking four participants in the final analysis. However, given the clarity of our results which showed no difference between treatment arms, the possibility of a type II error seems low; a minimally larger sample size would be unlikely to change our

599

finding. We also had multiple providers involved in clinical care throughout the study which could have introduced variation. We were unable to link providers to pain scores; variation in provider technique could have influenced pain scores and been a source of confounding. This variation seems unlikely to produce bias significant enough to change our results, but we were unable to control specifically for this factor. In addition, we only enrolled two subjects at gestational age greater than 21 weeks. Our conclusions about effectiveness in women of advanced gestational age are limited due to their under-representation in the study. Our findings of moderate pain scores in over 30% of women at laminaria insertion, despite use of paracervical block, suggest that the current clinical practice of paracervical block may not provide adequate analgesia for this procedure for many women. Intrauterine lidocaine does not seem to be an effective adjunct to paracervical block in controlling pain associated with laminaria insertion. Further research should be conducted to identify which women would benefit from other methods of pain control, and to identify more effective methods of pain control during laminaria insertion.

References [1] Newmann S, Dalve-Endres A, Drey EA. Clinical guidelines. Cervical preparation for surgical abortion from 20 to 24 weeks' gestation. Contraception 2008;77:308–14. [2] Newmann SJ, Dalve-Endres A, Diedrich JT, Steinauer JE, Meckstroth K, Drey EA. Cervical preparation for second trimester dilation and evacuation. Cochrane Database Syst Rev 2010:CD007310. [3] Fox MC, Hayes JL. Cervical preparation for second-trimester surgical abortion prior to 20 weeks of gestation. Contraception 2007;76:486–95. [4] MacIsaac L, Grossman D, Balistreri E, Darney P. A randomized controlled trial of laminaria, oral misoprostol, and vaginal misoprostol before abortion. Obstet Gynecol 1999;93:766–70. [5] Prairie BA, Lauria MR, Kapp N, Mackenzie T, Baker ER, George KE. Mifepristone versus laminaria: a randomized controlled trial of cervical ripening in midtrimester termination. Contraception 2007;76:383–8. [6] Drey EA, Benson LS, Sokoloff A, Steinauer JE, Roy G, Jackson RA. Buccal misoprostol plus laminaria for cervical preparation before dilation and evacuation at 21–23 weeks of gestation: a randomized controlled trial. Contraception 2014;89:307–13. [7] Borgatta L, Roncari D, Sonalkar S, Mark A, Hou MY, Finneseth M, et al. Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14–16 weeks: a randomized trial. Contraception 2012;86:567–71. [8] Goldberg AB, Drey EA, Whitaker AK, Kang MS, Meckstroth KR, Darney PD. Misoprostol compared with laminaria before early second-trimester surgical abortion: a randomized trial. Obstet Gynecol 2005;106:234–41. [9] Renner RM, Jensen JT, Nichols MD, Edelman AB. Pain control in first-trimester surgical abortion: a systematic review of randomized controlled trials. Contraception 2010;81:372–88. [10] Allen RH, Micks E, Edelman A. Pain relief for obstetric and gynecologic ambulatory procedures. Obstet Gynecol Clin North Am 2013;40:625–45. [11] Willard FH, Shuenke MD. The neuroanatomy of female pelvic pain. In: Bailey A, & Bernstein C, editors. Pain in women: a clinical guide. New York: Springer Science and Business Media; 2013, pp. 17–58.

600

R.J. Mercier, A. Liberty / Contraception 90 (2014) 594–600

[12] Costello MF, Horrowitz S, Steigrad S, Saif N, Bennett M, Ekangaki A. Transcervical intrauterine topical local anesthetic at hysterosalpingography: a prospective, randomized, double-blind, placebo-controlled trial. Fertil Steril 2002;78:1116–22. [13] Cicinelli E, Didonna T, Ambrosi G, Schonauer LM, Fiore G, Matteo MG. Topical anaesthesia for diagnostic hysteroscopy and endometrial biopsy in postmenopausal women: a randomised placebo-controlled double-blind study. Br J Obstet Gynaecol 1997;104:316–9. [14] Mercier RJ, Zerden ML. Intrauterine anesthesia for gynecologic procedures: a systematic review. Obstet Gynecol 2012;120:669–77. [15] Trolice MP, Fishburne Jr C, McGrady S. Anesthetic efficacy of intrauterine lidocaine for endometrial biopsy: a randomized doublemasked trial. Obstet Gynecol 2000;95:345–7. [16] Dogan E, Celiloglu M, Sarihan E, Demir A. Anesthetic effect of intrauterine lidocaine plus naproxen sodium in endometrial biopsy. Obstet Gynecol 2004;103:347–51. [17] Guney M, Oral B, Mungan T. Intrauterine lidocaine plus buccal misoprostol in the endometrial biopsy. Int J Gynaecol Obstet 2007;97:125–8. [18] Api O, Ergen B, Api M, Ugurel V, Emeksiz MB, Unal O. Comparison of oral nonsteroidal analgesic and intrauterine local anesthetic for pain relief in uterine fractional curettage: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol 2010;203:28.e1–7. [19] Rattanachaiyanont M, Leerasiri P, Indhavivadhana S. Effectiveness of intrauterine anesthesia for pain relief during fractional curettage. Obstet Gynecol 2005;106:533–9. [20] Gupta N, Ghosh B, Mittal S. Comparison of oral naproxen and intrauterine lignocaine instillation for pain relief during hysterosalpingography. Int J Gynaecol Obstet 2008;102:284–6. [21] Guney M, Oral B, Bayhan G, Mungan T. Intrauterine lidocaine infusion for pain relief during saline solution infusion sonohysterography: a randomized, controlled trial. J Minim Invasive Gynecol 2007;14:304–10.

[22] Edelman A, Nichols MD, Leclair C, Jensen JT. Four percent intrauterine lidocaine infusion for pain management in first-trimester abortions. Obstet Gynecol 2006;107:269–75. [23] Jamison RN, Raymond SA, Slawsby EA, McHugo GJ, Baird JC. Pain assessment in patients with low back pain: comparison of weekly recall and momentary electronic data. J Pain 2006;7:192–9. [24] Allen KD, Coffman CJ, Golightly YM, Stechuchak KM, Voils CI, Keefe FJ. Comparison of pain measures among patients with osteoarthritis. J Pain 2010;11:522–7. [25] Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med 1996;27:485–9. [26] Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med 2001;38:633–8. [27] Gallagher EJ, Bijur PE, Latimer C, Silver W. Reliability and validity of a visual analog scale for acute abdominal pain in the ED. Am J Emerg Med 2002;20:287–90. [28] Gagne A, Guilbert E, Ouellet J, Roy V, Tremblay JG. Assessment of pain after elective abortion relating to the use of misoprostol for dilatation of the cervix. J Obstet Gynaecol Can 2010;32:244–53. [29] Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken) 2011;63(Suppl 11):S240–52. [30] Hui SK, Lee L, Ong C, Yu V, Ho LC. Intrauterine lignocaine as an anaesthetic during endometrial sampling: a randomised double-blind controlled trial. BJOG 2006;113:53–7. [31] Edelman A, Nichols MD, Leclair C, Astley S, Shy K, Jensen JT. Intrauterine lidocaine infusion for pain management in first-trimester abortions. Obstet Gynecol 2004;103:1267–72.

Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial.

To determine if intrauterine administration of 5 cc of 2% lidocaine in addition to paracervical block reduces pain during laminaria insertion, when co...
486KB Sizes 0 Downloads 5 Views