Department of Obstetrics and Gynecology, the Department of Biomedical Investigations and Research, and the Division of FPMRS, Department of Obstetrics and Gynecology, Ascension St. John Hospital, Detroit, and Michigan State University, East Lansing, Michigan.
Obstet Gynecol. 2023 Jul 1;142(1):151-159. doi: 10.1097/AOG.0000000000005231. Epub 2023 Jun 7.
To evaluate whether decreasing insufflation pressure reduces postoperative pain and opioid use in women undergoing robotic-assisted sacrocolpopexy.
In a single-blinded randomized trial, women with pelvic organ prolapse underwent robotic-assisted sacrocolpopexy at either 12 mm Hg (experimental) or 15 mm Hg (standard) insufflation pressure. The primary outcome was pain rating on a visual analog scale (VAS) on postoperative day 1 within 24 hours of surgery. Secondary outcomes included VAS pain rating at outpatient follow-up, inpatient and outpatient use of opioids, operative time, and estimated blood loss. A margin of 15 mm was considered clinically different on the VAS, and at 80% power, a sample size of at least 64 participants was needed to show significance.
From April 27, 2021, to May 17, 2022, 80 women were enrolled, with 41 in the experimental group and 39 in the standard group. All participants underwent surgery as planned and attended a 2-week postoperative follow-up. Participants in the experimental group had less pain on postoperative day 1 with median VAS of 17.0 mm (interquartile range 26.0) compared with 29.0 mm (interquartile range 32.0, P=.007) in the standard group. No differences were noted in the secondary outcomes of operative time, estimated blood loss, or length of stay. Participants in the experimental group were noted to use fewer opioids while an inpatient (P=.04) and outpatient (P=.02). In multivariable analyses, lower insufflation pressure and increasing age were negatively associated with postoperative VAS scores.
Lowering insufflation pressure (12 mm Hg) during robotic-assisted sacrocolpopexy safely reduced postoperative pain and opioid use compared with standard pressure (15 mm Hg).
ClinialTrials.gov, NCT04858438.
评估在接受机器人辅助骶骨阴道固定术的女性中，降低注气压力是否会减轻术后疼痛和减少阿片类药物的使用。
在一项单盲随机试验中，患有盆腔器官脱垂的女性以 12 毫米汞柱（实验组）或 15 毫米汞柱（标准组）的注气压力接受机器人辅助骶骨阴道固定术。主要结局是手术 24 小时内术后第 1 天的视觉模拟评分（VAS）疼痛评分。次要结局包括门诊随访时的 VAS 疼痛评分、住院和门诊使用阿片类药物、手术时间和估计失血量。VAS 上 15 毫米的差值被认为具有临床意义，在 80%的功效下，至少需要 64 名参与者的样本量才能显示出显著性。
从 2021 年 4 月 27 日至 2022 年 5 月 17 日，共纳入 80 名女性，实验组 41 名，标准组 39 名。所有参与者均按计划接受手术，并在术后 2 周进行随访。实验组在术后第 1 天的疼痛较轻，中位数 VAS 为 17.0 毫米（四分位间距 26.0），而标准组为 29.0 毫米（四分位间距 32.0，P=0.007）。手术时间、估计失血量或住院时间等次要结局无差异。实验组在住院（P=0.04）和门诊（P=0.02）时使用的阿片类药物较少。多变量分析显示，较低的注气压力和年龄增加与术后 VAS 评分呈负相关。
与标准压力（15 毫米汞柱）相比，在机器人辅助骶骨阴道固定术中降低注气压力（12 毫米汞柱）可安全减轻术后疼痛和减少阿片类药物的使用。
ClinialTrials.gov，NCT04858438。
