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一项关于局部镇痛对经骶棘韧带阴道骶骨固定术后臀肌疼痛影响的随机双盲安慰剂对照试验。

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

机构信息

Center for Urogynecology & Pelvic Reconstructive Surgery, Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic, Cleveland, OH.

Center for Urogynecology & Pelvic Reconstructive Surgery, Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic, Cleveland, OH.

出版信息

Am J Obstet Gynecol. 2018 Jun;218(6):599.e1-599.e8. doi: 10.1016/j.ajog.2018.03.033. Epub 2018 Mar 31.

DOI:10.1016/j.ajog.2018.03.033
PMID:29614274
Abstract

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.

摘要

背景

骶棘韧带固定术后暂时性臀痛的发生率为 6.1%至 15.3%。臀痛可能是由于 S3 至 S5 神经根在悬吊缝线放置时穿过尾骨-骶棘韧带复合体的中部而受伤引起的。目前尚无关于在缝线放置时使用注射来预防神经受压引起的术后疼痛的数据。

目的

本研究旨在确定在骶棘韧带水平给予术中局部镇痛是否可以减轻骶棘韧带固定术后患者的术后臀痛。

研究设计

在一项随机双盲安慰剂对照试验中,接受骶棘韧带固定术治疗阴道顶点脱垂的女性在手术过程中接受 0.25%布比卡因或生理盐水注射。受试者在 6 周内完成视觉模拟疼痛量表(0-10)和活动评估量表,并记录止痛药的使用情况。主要结局是术后臀痛。计划招募 50 名受试者(每组 25 名),以检验局部镇痛给药将减轻术后疼痛的假设。

结果

2014 年 4 月至 2016 年 3 月,共有 51 名女性入组该研究,46 名女性接受了骶棘韧带固定术。术后第 1 天,所有受试者(n=41)中有 90.2%报告臀痛。第 1 周和第 2 周,分别有 63.8%(n=29)和 44.1%(n=20)的女性报告疼痛;第 4 周和第 6 周,分别有 33.3%(n=15)和 26.9%(n=12)的女性仍有一些疼痛。第 1 天,臀痛的平均评分为 3.7±2.9。第 1 周时,评分降至 1.8±2.6;第 6 周时,平均评分为 0.1±0.3。接受 0.25%布比卡因注射和生理盐水注射的患者疼痛评分无差异。接受安慰剂治疗的患者比接受治疗的患者使用更多的非甾体抗炎药:调整后的优势比为 1.25;95%置信区间为 1.04-1.35;P=.01)。6 周后,87.5%的患者恢复到基线“轻度”活动水平。两组之间无差异。

结论

骶棘韧带固定术后,术中给予局部镇痛并不能减轻患者对术后臀痛的感知;然而,它可能会减少术后对止痛药的需求。

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