Jennifer Yeung

Liposomal bupivacaine decreases pain following retropubic sling placement: a randomized placebo-controlled trial

BACKGROUND: Midurethral slings are commonly used to treat stress urinary incontinence. Pain control, however, may be a concern. Liposomal bupivacaine is a local anesthetic with slow release over 72 hours, demonstrated to lower pain scores and decrease narcotic use postoperatively. OBJECTIVE: The purpose of this study was to examine the impact of liposomal bupivacaine on pain scores and narcotic consumption following retropubic midurethral sling placement. STUDY DESIGN: This randomized, placebo‐controlled trial enrolled women undergoing retropubic midurethral sling procedures with or without concomitant anterior or urethrocele repair. Subjects were allocated to receive liposomal bupivacaine (intervention) or normal saline placebo injected into the trocar paths and vaginal incision at the conclusion of the procedure. At the time of drug administration, surgeons became unblinded, but did not collect outcome data. Participants remained blinded to treatment. Surgical procedures and perioperative care were standardized. The primary outcome was the visual analog scale pain score 4 hours after discharge home. Secondary outcomes included narcotic consumption, time to first bowel movement, and pain scores collected in the mornings and evenings until postoperative day 6. The morning pain item assessed “current level of pain”; the evening items queried “current level of pain,” “most intense pain today,” “average pain today with activity,” and “average pain today with rest.” Likert scales were used to measure satisfaction with pain control at 1‐ and 2‐week postoperative intervals. Sample size calculation deemed 52 subjects per arm necessary to detect a mean difference of 10 mm on a 100‐mm visual analog scale. To account for 10% drop out, 114 participants were needed. RESULTS: One hundred fourteen women were enrolled. After 5 exclusions, 109 cases were analyzed: 54 women received intervention, and 55 women received placebo. Mean participant age was 52 years, and mean body mass index was 30.4 kg/m2. Surgical and demographic characteristics were similar, except for a slightly higher body mass index in the placebo group (31.6 vs 29.2 kg/m2; P=.050), and fewer placebo arm subjects received midazolam during anesthesia induction (44 vs 52; P=.015). For the primary outcome, pain score (millimeter) 4 hours after discharge home was lower in the intervention group (3.5 vs 13.0 millimeters; P=.014). Pain scores were also lower for subjects receiving liposomal bupivacaine at other time points collected during the first three postoperative days. Furthermore, fewer subjects in the intervention group consumed narcotic medication on postoperative day 2 (12 vs 27; P=.006). There was no difference in satisfaction with pain control between groups. Side‐effects experienced, rate of postoperative urinary retention, and time to first bowel movement were similar between groups. Finally, no serious adverse events were noted. CONCLUSION: Liposomal bupivacaine decreased postoperative pain scores following retropubic midurethral sling placement, though pain was low in both the intervention and placebo groups. Participants who received liposomal bupivacaine were less likely to use narcotics on postoperative day 2. For this common outpatient surgery, liposomal bupivacaine may be a beneficial addition. Given the cost of this intervention, however, future cost‐effective analyses may be useful.

Anatomy of the Vulva and the Female Sexual Response.

The female vulva is an intricate structure comprising several components. Each structure has been described separately, but the interplay among them and physiologic significance remain controversial. The structures extend inferiorly from the pubic arch and include the mons pubis, labia majora, labia minora, vestibule, and clitoris. The clitoris is widely accepted as the most critical anatomic structure to female sexual arousal and orgasm. The female sexual response cycle is also very complex, requiring emotional and mental stimulation in addition to end organ stimulation.

Liposomal Bupivacaine During Robotic Colpopexy and Posterior Repair: A Randomized Controlled Trial

OBJECTIVE To evaluate the effect of liposomal bupivacaine on postoperative pain among patients undergoing robotic sacrocolpopexy with posterior repair. METHODS This was a randomized, patient-blinded, placebo-controlled trial of women undergoing robotic sacrocolpopexy with posterior repair. Liposomal bupivacaine or normal saline placebo was injected into laparoscopic and vaginal incisions at completion of surgery. Perioperative care was standardized. Visual analog scales were collected at 4, 18, and 24 hours postoperatively in hospital. Starting on postoperative day 1, participants completed twice-daily pain scales and a pain medication diary up until the evening of postoperative day 3. The primary outcome was a 20-mm change in the visual analog scale 18 hours postoperatively. Secondary measures included additional pain scores, satisfaction, and narcotic use. Sample size calculation revealed that 32 patients per arm were required to detect the 20-mm difference with 90% power and an α of 0.05. To allocate for dropout, a goal of 70 was set. RESULTS Between March 2015 and April 2016, 100 women were screened and 70 women were enrolled: 35 women were randomized to liposomal bupivacaine and 35 to placebo, of whom 64 (91%) were included in the final analysis: 33 liposomal bupivacaine and 31 placebo. No difference in demographics, surgical data, or satisfaction between groups was noted. Median VAS at 18 hours after surgery was not statistically different in those who received liposomal bupivacaine compared with normal saline (15 mm compared with 20 mm; P=.52). Other pain scales and total morphine equivalents were also similar (P=.90). CONCLUSION In this study of robotic sacrocolpopexy with posterior repair, there were no differences in pain scores or narcotic use between liposomal bupivacaine and placebo injected into laparoscopic and vaginal incisions. Given its lack of clinical benefit, routine use of liposomal bupivacaine is not supported for this surgical intervention. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT02449915.

14: Impact of liposomal bupivacaine on pain following retropubic midurethral sling placement: A randomized placebo-controlled trial

non-completion of planned salpingectomy. MRS scores were compared using paired t-tests. RESULTS: Among 70 patients offered enrollment in this study, 67 (96%) consented, and complete data are available for 62 (93%). Mean age was 51.1 years ( 9.4). Median body mass index (BMI) was 27.1 kg/m2; median vaginal parity was 2 (0-4), and 43% were postmenopausal. The primary indication for hysterectomy was prolapse (76%), heavy menstrual bleeding (18%), and other (6%). Vaginal salpingectomy was successfully performed in 46/62 (74%) women. Mean operating time for bilateral salpingectomy was 11 minutes ( 5.7), with additional mean EBL of 6 cc ( 17.3). There were 8 surgical complications: 3 hemorrhages > 500 ml and 5 conversions to alternate routes of surgery, but none of these were due to the salpingectomy. Mean uterine weight was 68 grams and there were no abnormalities on fallopian tube pathology. Among the 16 patients in whom planned bilateral salpingectomy was not completed, unilateral salpingectomy was performed in 6 and both tubes were left in situ in 10. Reasons for non-completion of salpingectomy included: tubes were too high in the pelvis (7), conversion to alternate route for pathology (2), ovarian adhesions (2), bowel or sidewall adhesions (3), no reason (1), and ovarian pathology requiring oophorectomy (1). There were no identified risk factors for unsuccessful salpingectomy including age (p 1⁄4 0.05), BMI (p 1⁄4 0.68), and prior tubal ligation (p 1⁄4 0.052). Mean MRS scores did not significantly change from preoperatively to postoperatively (9.85 vs 6.04, p 1⁄4 0.61). CONCLUSION: Vaginal salpingectomy is feasible in the majority of women undergoing planned vaginal hysterectomy and increases operating time by 11 minutes and EBL by 6 cc. Risk factors for unsuccessful removal could not be identified.