Massachusetts General Hospital, Boston, Massachusetts; the University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Brigham and Women's Hospital, Boston, Massachusetts; the George Washington University School of Medicine and Health Sciences, Washington, DC; and Mayo Clinic, Rochester, Minnesota.
Obstet Gynecol. 2021 Apr 1;137(4):648-656. doi: 10.1097/AOG.0000000000004329.
To assess whether a superior hypogastric plexus block performed during laparoscopic hysterectomy reduces postoperative pain.
We conducted a multicenter, randomized, single-blind, controlled trial of superior hypogastric plexus block at the start of laparoscopic hysterectomy. Women undergoing a laparoscopic hysterectomy for any indication and with any other concomitant laparoscopic procedure were eligible. Standardized preoperative medications and incisional analgesia were provided to all patients. Our primary outcome was the proportion of patients with a mean visual analog scale (VAS) pain score lower than 4 within 2 hours postoperatively. Patients but not surgeons were blinded to the treatment group. Twenty-nine patients per group was estimated to be sufficient to detect a 38% absolute difference in the proportion of patients with a VAS score lower than 4 at 2 hours postoperatively, with 80% power and an α of 0.05. To account for loss to follow-up and potential imbalances in patient characteristics, we planned to enroll 50 patients per group. All analyses were intention to treat.
Between January 2018 and February 2019, 186 patients were eligible; 100 were randomized and analyzed. Demographic and clinical characteristics were similar between the two groups. There was no significant difference in the proportion of patients with a mean VAS score lower than 4 within 2 hours postoperatively between patients who received a superior hypogastric plexus block (57%) and patients who did not (43%) (odds ratio 1.63, 95% CI 0.74-3.59; adjusted odds ratio 1.84, 95% CI 0.75-4.51).
Among patients undergoing laparoscopic hysterectomy with standardized enhanced perioperative recovery pathways, superior hypogastric plexus block did not significantly reduce postoperative pain.
ClinicalTrials.gov, NCT03283436.
评估腹腔镜子宫切除术中行上腹下丛阻滞是否能减轻术后疼痛。
我们进行了一项多中心、随机、单盲、对照试验,在腹腔镜子宫切除术前开始行上腹下丛阻滞。接受任何原因腹腔镜子宫切除术且伴有任何其他腹腔镜辅助手术的患者符合入组条件。所有患者均给予标准化的术前用药和切口镇痛。我们的主要结局是术后 2 小时内视觉模拟评分(VAS)疼痛评分低于 4 分的患者比例。患者而非外科医生对治疗组设盲。预计每组 29 例患者即可检测到术后 2 小时 VAS 评分低于 4 分的患者比例有 38%的绝对差异,检验效能为 80%,α 值为 0.05。为了考虑失访和潜在的患者特征不平衡,我们计划每组纳入 50 例患者。所有分析均采用意向治疗。
2018 年 1 月至 2019 年 2 月期间,共有 186 例患者符合条件,其中 100 例患者被随机分组并进行分析。两组患者的人口统计学和临床特征相似。接受上腹下丛阻滞的患者中术后 2 小时内 VAS 评分低于 4 分的患者比例(57%)与未接受阻滞的患者(43%)无显著差异(优势比 1.63,95%置信区间 0.74-3.59;校正优势比 1.84,95%置信区间 0.75-4.51)。
在接受标准化增强围手术期康复途径的腹腔镜子宫切除术患者中,上腹下丛阻滞并未显著减轻术后疼痛。
ClinicalTrials.gov,NCT03283436。