Study of the Analgesic Effect of the Perineal Infiltration of Ropivacaine 0.75% Versus Placebo in Post-episiotomy Perineal Pain: a Randomized, Double-blind Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 2
- 主要终点
- Compare the analgesic efficacy of ropivacaine 75 mg infusion versus placebo (physiological saline) in patients with right mid-lateral episiotomy during postpartum D7 delivery.
研究概览
简要总结
Episiotomy is a common obstetric gesture (20 to 30% of deliveries by the low route). In postpartum, perineal pains associated with episiotomy are common, about 70% on D7 and persistent 13% at 5 months. Most studies of obstetrical analgesia have focussed on pain during labor or following a caesarean section. The perineal pain associated with the realization of an episiotomy has been much less studied and often undervalued.
Local ropivacaine has shown its effectiveness in the reduction of postoperative pain in many indications (wall surgery, hemorrhoidectomy, infiltration of trocar scars during laparoscopy). This product has the advantage of being well tolerated, easy access and administration. Three recent studies compared the post-episiotomy analgesic efficacy of local ropivacaine versus lidocaine versus placebo and lidocaine versus no infiltration. Two of these studies showed statistically significant results. However, they focused on the results at 24 and 48 hours and did not evaluate the analgesic efficacy in the medium and long term.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Major Patient (≥ 18 years)
- •Term ≥ 37 weeks of amenorrhea
- •Right medio-lateral episiotomy performed for medical need
- •Delivery of a single fetus in a cephalic presentation with or without instrumental extraction
- •Delivery under epidural anesthesia
- •Patient to be monitored over 6 months of study
- •Patient in ability to understand protocol
- •Patient having given consent and signed informed consent
- •Patient with social coverage
排除标准
- •Hypersensitivity or known allergy to Ropivacaine or to other amide-linked local anesthetics or to any of the excipients
- •General contraindication specific to local anesthesia, irrespective of the local anesthetic used
- •Contraindication for Ropivacaine- Obstetric paracervical anesthesia
- •Hypovolemia
- •Weight <50 kg
- •Contra-indication or refusal of the epidural
- •Poor understanding of the French language
- •Substance addiction.
- •Chronic pain syndrome.
- •Severe hepatic or renal impairment.
- •Acute porphyria.
- •Caesarean section programmed.
- •Tear of the 3rd degree according to the associated French classification.
- •Refusal to participate in the study
- •Patient under tutelage, curatorship, or deprived of liberty
研究组 & 干预措施
Ropivacaïne
干预措施: Administration of Ropivacaïne (Drug)
Placebo
干预措施: Administration of placebo (Drug)
结局指标
主要结局
Compare the analgesic efficacy of ropivacaine 75 mg infusion versus placebo (physiological saline) in patients with right mid-lateral episiotomy during postpartum D7 delivery.
时间窗: 7 days after episiotomy
Digital pain scale
次要结局
未报告次要终点