A randomized double-blind placebo-controlled trial on the effect of local analgesia on postoperative gluteal pain in patients undergoing sacrospinous ligament colpopexy

BACKGROUND: The incidence of temporary gluteal pain after sacrospinous ligament colpopexy ranges from 6.1% to 15.3%. Gluteal pain may occur as a result of injury to S3 to S5 nerve roots that course over the mid-portion of the coccygeus-sacrospinous ligament complex at the time of suspension suture placement. There are no data on the use of injections to prevent postoperative pain from nerve entrapment at the time of suture placement. OBJECTIVE: The purpose of this study was to determine whether intraoperative local analgesia that is administered at the level of the sacrospinous ligament can lessen the gluteal pain felt by patients postoperatively after sacrospinous ligament colpopexy. STUDY DESIGN: In a randomized double-blind placebo-controlled trial, women with vaginal apex prolapse who were undergoing surgical treatment with sacrospinous ligament colpopexy underwent intraoperative injection with either 0.25% bupivacaine or normal saline solution. Subjects completed visual analog pain scales (0-10) and the Activities Assessment Scale and recorded the use of pain medications over a 6-week period. The primary outcome was postoperative gluteal pain. A sample size of 50 subjects (25 in each arm) was planned to test the hypothesis that local analgesia administration will lessen postoperative pain compared with placebo. RESULTS: Between April 2014 and March 2016, 51 women were enrolled in the study, and 46 women underwent sacrospinous ligament colpopexy. On postoperative day 1, 90.2% of all subjects (n = 41) reported gluteal pain. At weeks 1 and 2, 63.8% (n = 29) and 44.1% (n = 20) women reported pain; at weeks 4 and 6, 33.3%(n = 15) and 26.9%(n = 12) women continued to have some pain. On day 1, the mean score for gluteal pain was 3.7 +/- 2.9. By week 1, the score was 1.8 +/- 2.6; by week 6, the mean score was 0.1 +/- 0.3. There were no differences in pain scores for patients who had undergone injection with 0.25% bupivacaine and those who were injected with normal saline solution. Patients in the placebo group used significantly more nonsteroidal antiinflammatory drugs than the treatment group: adjusted odds ratio, 1.25; 95% confidence interval, 1.04-1.35; P=.01). By 6 weeks, 87.5% of patients had returned to their baseline "light" activity level. There was no difference in time to return to baseline between the groups. CONCLUSION: Intraoperative administration of local analgesia does not reduce patients' perceptions of postoperative gluteal pain after sacrospinous ligament colpopexy; however, it may reduce the need for pain medication after surgery.