Xiong Xingyu, Tao Mingshu, Zhao Wenxin, Tan Wen, Jiang Yanyu, Sun Zhengxiu, Wang Yuanyuan, Lin Yongao, Li Chunyan, Yang Jie, Han Yuan, Zhang Hongxing, Zhang Song, Liu He, Cao Jun-Li
Department of Anesthesiology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
National Medical Products Administration Key Laboratory for Research and Evaluation of Narcotic and Psychotropic Drugs, Xuzhou Medical University, Xuzhou, China.
JAMA Netw Open. 2025 Aug 1;8(8):e2529127. doi: 10.1001/jamanetworkopen.2025.29127.
Postpartum uterine contraction pain manifests as a severe, intermittent lower abdominal discomfort caused by uterine contraction during the early puerperium. Transcutaneous auricular vagus nerve stimulation (taVNS) has demonstrated promising effects in managing both acute and chronic pain conditions; however, there remains a paucity of studies regarding the use of taVNS for alleviating postpartum uterine contraction pain.
To investigate the effect of taVNS in alleviating postpartum uterine contraction pain among women receiving combined spinal-epidural anesthesia for elective cesarean delivery.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted from April 6 to August 31, 2024, at the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China. Participants were aged 18 years or older and scheduled for elective cesarean delivery. Statistical analysis was performed in September 2024. All analyses were conducted according to the intention-to-treat principle.
Participants were randomly allocated 1:1 to either the active taVNS group or the sham taVNS group. Both groups received the stimulation for 30 minutes each time, once a day, on the day of surgery and postoperative days 1 and 2.
The primary outcome was the incidence of moderate to severe postpartum uterine contraction pain on the third postoperative day, evaluated using a visual analogue scale (uterine contraction pain was classified as moderate to severe if the score was ≥4). Secondary outcomes included peak uterine contraction pain and incision pain, postpartum anxiety, postpartum depression, postpartum recovery quality, and sleep quality.
A total of 156 women were recruited and randomized to the active taVNS group (78 patients; mean [SD] age, 31.5 [4.3] years) or the sham taVNS group (78 patients; mean [SD] age, 31.3 [4.5] years). The incidence of moderate to severe uterine contraction pain in the active taVNS group was 5.1% (4 of 78) compared with 28.2% (22 of 78) in the sham taVNS group on the third postoperative day (relative risk, 0.18 [95% CI, 0.07-0.50]; P < .001) The active taVNS group had lower median scores on the third postoperative day for incisional pain (visual analogue score: 2.20 [IQR, 2.00-2.50] vs 3.00 [IQR, 2.60-3.33]), depression (EPDS: 3.00 [IQR, 2.00-4.00] vs 5.00 [IQR, 3.00-6.00]), and anxiety (PRAQ-R2: 13.50 [IQR, 12.00-15.00] vs 15.00 [IQR, 13.75-17.00]), as well as significantly higher scores for recovery quality on the third postoperative day (ObsQoR-11: 104 [IQR, 103-105] vs 99 [IQR, 96-101]) and sleep quality on the second postoperative day (LSEQ: 52.00 [IQR, 50.00-55.00] vs 47.50 [IQR, 43.00-52.00]) compared with the sham taVNS group.
In this randomized clinical trial, taVNS significantly reduced uterine contraction pain, incisional pain, depression, and anxiety, and improved recovery quality and sleep quality compared with sham taVNS. These findings suggest that taVNS represents a novel and safe strategy for alleviating postpartum uterine contraction pain among women undergoing cesarean delivery and for promoting postoperative recovery.
Chinese Clinical Trial Register Identifier: ChiCTR2400082716.
产后子宫收缩痛表现为产褥早期子宫收缩引起的严重、间歇性下腹部不适。经皮耳迷走神经刺激（taVNS）已在治疗急性和慢性疼痛方面显示出有前景的效果；然而，关于使用taVNS缓解产后子宫收缩痛的研究仍然匮乏。
探讨taVNS对择期剖宫产接受腰硬联合麻醉的女性产后子宫收缩痛的缓解作用。
设计、地点和参与者：这项随机临床试验于2024年4月6日至8月31日在中国徐州徐州医科大学附属医院进行。参与者年龄在18岁及以上，计划进行择期剖宫产。2024年9月进行统计分析。所有分析均按照意向性分析原则进行。
参与者按1:1随机分配至taVNS治疗组或假taVNS组。两组均在手术当天及术后第1天和第2天，每次接受30分钟刺激，每天1次。
主要结局是术后第3天中度至重度产后子宫收缩痛的发生率，采用视觉模拟评分法评估（如果评分≥4分，子宫收缩痛被分类为中度至重度）。次要结局包括子宫收缩痛峰值和切口痛、产后焦虑、产后抑郁、产后恢复质量和睡眠质量。
共招募了156名女性并随机分为taVNS治疗组（78例患者；平均[标准差]年龄，31.5[4.3]岁）或假taVNS组（78例患者；平均[标准差]年龄，31.3[4.5]岁）。术后第3天，taVNS治疗组中度至重度子宫收缩痛的发生率为5.1%（78例中的4例），而假taVNS组为28.2%（78例中的22例）（相对危险度，0.18[95%可信区间，0.07 - 0.50]；P <.001）。与假taVNS组相比，taVNS治疗组术后第3天切口痛（视觉模拟评分：2.20[四分位数间距，2.00 - 2.50]对3.00[四分位数间距，2.60 - 3.33]）、抑郁（爱丁堡产后抑郁量表：3.00[四分位数间距，2.00 - 4.00]对5.00[四分位数间距，3.00 - 6.00]）和焦虑（产后快速焦虑自评量表 - R2：13.50[四分位数间距，12.00 - 15.0（此处原文有误，应为15.00[四分位数间距，13.75 - 17.00]）]）的中位数得分更低，术后第3天恢复质量得分（观察性产后恢复质量量表 - 11：104[四分位数间距，103 - 105]对99[四分位数间距，96 - 101]）和术后第2天睡眠质量得分（利物浦睡眠质量量表：52.00[四分位数间距，50.00 - 55.00]对47.50[四分位数间距，43.00 - 52.00]）显著更高。
在这项随机临床试验中，与假taVNS相比，taVNS显著减轻了子宫收缩痛、切口痛、抑郁和焦虑，并改善了恢复质量和睡眠质量。这些发现表明，taVNS是一种缓解剖宫产女性产后子宫收缩痛和促进术后恢复的新型安全策略。
中国临床试验注册标识符：ChiCTR2400082716 。
