Department of Obstetrics and Gynaecology and Reproductive Medicine, Nantes University Hospital, Nantes, France.
Federative Pelvic Pain Centre, Nantes University Hospital, Nantes, France.
BJOG. 2024 Jun;131(7):899-907. doi: 10.1111/1471-0528.17266. Epub 2022 Aug 11.
To investigate whether perineal infiltration of ropivacaine after episiotomy would decrease the incidence of postpartum pain compared with placebo.
Two-centre, double-blind, randomised, controlled trial.
Two French maternity units, October 2017 to April 2020.
272 women undergoing epidural analgesia with vaginal singleton delivery and mediolateral episiotomy at term (≥37 weeks) were randomly allocated perineal infiltration of ropivacaine (n = 135) or placebo (n = 137) in a 1:1 ratio before episiotomy repair.
Patients were followed at short term (12, 24, 48 h), mid-term (day 7) and long-term (3 and 6 months).
The primary outcome was the rate of perineal pain, defined by a Numerical Pain Rating Scale (NPRS) exceeding 3/10, in the mid-term (day 7) postpartum period. Secondary outcomes were perineal pain (NPRS) and analgesic intake, quality of life (SF-36), postpartum depression (EPDS), pain neuropathic component (DN4) and sexual health (FSFI).
Perineal pain occurred to an equal extent in the ropivacaine and placebo groups at day 7 (34.2% versus 30.4%, odds ratio 1.1, 95% confidence interval 0.7-1.8, p = 0.63). Similar results were recorded in the short and long term. High rates of dyspareunia and postpartum depression were documented in both groups. No differences were highlighted between the groups in terms of analgesic intake, adverse events, pain neuropathic component and postpartum quality of life.
This study did not demonstrate any benefit of ropivacaine infiltration over placebo.
研究会阴侧切术后局部浸润罗哌卡因是否会降低产后疼痛的发生率，与安慰剂相比。
两中心、双盲、随机、对照试验。
2017 年 10 月至 2020 年 4 月，法国两个产科单位。
272 名接受硬膜外镇痛、足月（≥37 周）阴道单胎分娩和会阴正中切开术的女性，在会阴切开修复前以 1:1 的比例随机分为罗哌卡因（n=135）或安慰剂（n=137）局部浸润。
患者在短期（12、24、48 小时）、中期（第 7 天）和长期（3 和 6 个月）进行随访。
主要观察指标是中期（第 7 天）产后会阴疼痛的发生率，定义为数字疼痛评分量表（NPRS）超过 3/10。次要观察指标为会阴疼痛（NPRS）和镇痛药摄入量、生活质量（SF-36）、产后抑郁（EPDS）、疼痛神经病变成分（DN4）和性健康（FSFI）。
罗哌卡因组和安慰剂组在第 7 天的会阴疼痛发生率相同（34.2%与 30.4%，比值比 1.1，95%置信区间 0.7-1.8，p=0.63）。短期和长期的结果相似。两组均有较高的性交痛和产后抑郁发生率。两组在镇痛药摄入量、不良反应、疼痛神经病变成分和产后生活质量方面无差异。
本研究未显示罗哌卡因浸润与安慰剂相比有任何优势。
