加巴喷丁用于子宫吸引术围手术期疼痛管理的随机对照试验。
Gabapentin for Perioperative Pain Management for Uterine Aspiration: A Randomized Controlled Trial.
机构信息
Department of Obstetrics and Gynecology, Duke University Medical Center, and the Duke Office of Clinical Research and the Department of Biostatistics & Bioinformatics, BERD Methods Core, Duke University School of Medicine, Durham, North Carolina; and the Department of Gynecology and Obstetrics, Emory University School of Medicine, Atlanta, Georgia.
出版信息
Obstet Gynecol. 2019 Sep;134(3):611-619. doi: 10.1097/AOG.0000000000003398.
OBJECTIVE
To evaluate the effect of oral gabapentin in conjunction with usual oral pain management regimens of lorazepam, ibuprofen, oxycodone, and acetaminophen for surgical abortion on pain 5 minutes postprocedure.
METHODS
This was a randomized, double-blind, placebo-controlled trial of patients from 6 0/7-14 6/7 weeks of gestation scheduled to undergo surgical abortion at the Duke Family Planning Clinic. Participants were administered 600 mg of oral gabapentin compared with placebo with usual oral pain management. Pain score was assessed using a 100-mm visual analog scale, with the primary outcome being pain score 5 minutes after the procedure. The effect of gabapentin was assessed using a linear regression model controlling for baseline pain. We also measured pain perception 24 hours after the procedure. Secondary outcome measures included anxiety, side effects, and usage of opiate pain medication in the 24-hour postoperative period.
RESULTS
Out of 113 women screened for this study; 96 women were recruited, enrolled, and randomized to study treatment arm from August 2016 to June 2018. Pain at 5 minutes after the procedure was similar between the gabapentin and placebo groups ((Equation is included in full-text article.)=3.40; 95% CI -8.20 to 15.0; P=.56). Gabapentin and placebo were well tolerated, with no statistically significant difference in side effects or anxiety levels. Although prescription of opioids after the procedure was not standardized among patients, 73% of women received a short-term prescription for oxycodone. A lower percentage of women in the gabapentin group self-reported taking opioids in the 24 hours postprocedure (18% vs 47%; odds ratio 0.26; 95% CI 0.09-0.75).
CONCLUSION
The addition of gabapentin to usual oral pain management regimens with paracervical block did not reduce postoperative pain for patients undergoing outpatient surgical abortion. Although the addition of gabapentin was well tolerated and reduced oral opiate use 24 hours postprocedure, it did not affect the experience of pain during and immediately after the procedure.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT02725710.
目的
评估口服加巴喷丁联合通常的口服疼痛管理方案（劳拉西泮、布洛芬、羟考酮和对乙酰氨基酚）对 6 至 7 周妊娠行手术流产患者术后 5 分钟疼痛的影响。
方法
这是一项在杜克计划生育诊所行手术流产的 6 至 7 周妊娠患者的随机、双盲、安慰剂对照试验。参与者给予 600mg 口服加巴喷丁与安慰剂联合通常的口服疼痛管理。使用 100mm 视觉模拟量表评估疼痛评分，主要结局为术后 5 分钟的疼痛评分。使用线性回归模型控制基线疼痛评估加巴喷丁的效果。我们还测量了术后 24 小时的疼痛感知。次要结局包括术后 24 小时的焦虑、副作用和阿片类止痛药的使用。
结果
在这项研究中，共有 113 名女性接受了筛查；96 名女性于 2016 年 8 月至 2018 年 6 月被招募、入组并随机分配至研究治疗组。术后 5 分钟时，加巴喷丁组和安慰剂组的疼痛相似（(方程式包含在全文中) = 3.40；95%CI-8.20 至 15.0；P=.56）。加巴喷丁和安慰剂均耐受良好，副作用和焦虑水平无统计学差异。尽管患者之间术后开阿片类药物的处方未标准化，但 73%的女性短期开具了羟考酮处方。加巴喷丁组报告在术后 24 小时内服用阿片类药物的女性比例较低（18%对 47%；比值比 0.26；95%CI 0.09-0.75）。
结论
加巴喷丁联合宫颈旁阻滞的通常口服疼痛管理方案并不能降低门诊手术流产患者的术后疼痛。尽管加巴喷丁的添加耐受良好且术后 24 小时减少了口服阿片类药物的使用，但它并没有影响手术期间和之后立即的疼痛体验。
临床试验注册
ClinicalTrials.gov，NCT02725710。
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