Lignocaine vs Bupivacaine Infiltration for Postpartum Perineal Pain After Vaginal Delivery With Episiotomy in Primigravidae: A Prospective Randomized, Double-Blind, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Degree of pain
研究概览
简要总结
In this study, we will compare the effect and safety of lignocaine versus bupivacaine infiltration for postpartum perineal pain after vaginal delivery with episiotomy in primigravidae.
详细描述
Episiotomy is the most common procedure used for dilatation of the vaginal opening for giving birth. Although episiotomy is associated with benefits for the mother, it may lead to short term and long-term disabilities, including postpartum perineal pain that is secondary to perineal tearing. The perineal pain experienced due to receiving an episiotomy is severe during the first few days after delivery, and it can lead to limitations in movement and difficulties with urination and defecation.
Bupivacaine is a long-acting local anesthetic that effectively reduces postoperative pain. In practice, bupivacaine is used for infiltration anesthesia, nerve blocks, epidural, and caudal anesthesia. It has a more selective effect on sensory nerve fibers as compared to motor nerve fibers, therefore is preferred in obstetrics.
Lignocaine infiltration, with the presence or absence of epidural anesthesia, is the most frequently employed local anesthetic in ameliorating postpartum perineal pain. It is a rapid-onset amide local anesthetic with a short duration of action lasting up to two hours.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primigravidae with the full term undergoing vaginal delivery with episiotomy.
- •Pregnancies and singleton vertex cephalic fetuses.
- •In the active phase of the first stage of labor.
排除标准
- •Patients with history of drug allergies to study drugs as this will increase the risk of complications.
- •Patients undergoing vaginal delivery under epidural or spinal anesthesia as they will affect post-operative pain and interfere with assessment of efficacy of local infiltration of the study drugs.
- •Evidence of local infection at site of injection as this will interfere with the action of the study drug and will increase the risk of complications.
- •Inability to cooperate as this will affect our assessment.
- •Patient's refusal.
- •Any intraoperative complications that will affect our outcome criteria (bleeding, organ injury) as they will affect patient's vital data and affect our assessment.
- •Neurological comorbidities (chronic pain disorder, chronic systemic disease, neurological disorder, neuropathic pain) as they will need more analgesia.
- •Drug abuse as they will be tolerant to the used analgesics.
研究组 & 干预措施
Lignocaine group
A perineal infiltration of a 5-ml of the drug (100 mg of lignocaine) in the margins of the episiotomy. Careful aspiration before and during injection of the product should be performed to prevent intravascular injection. The entire contents will then be injected slowly at several points of infiltration. All planes will be infiltrated (vagina, muscle, and skin) before episiotomy repair.
干预措施: Lignocaine (Drug)
Bupivacaine group
A perineal infiltration of a 5-ml of the study drug (20 mg of Bupivacaine) in the margins of the episiotomy. Careful aspiration before and during injection of the product should be performed to prevent intravascular injection. The entire contents will then be injected slowly at several points of infiltration. All planes will be infiltrated (vagina, muscle, and skin) before episiotomy repair.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Degree of pain
时间窗: 6 hours postoperatively
Degree of pain will be assessed using the visual analogue scale (VAS) is the scale that will be used to assess postoperative pain and its intensity. A respondent will select a whole number (0- 10 integers) that best reflects the intensity of her pain, 1-10 will be recorded. Postoperative analgesic effect will be assessed using numeric version of the visual analogue scale (VAS) after delivery and local anesthetic infiltration (immediately after delivery, after 2 hours, after 4 hours, and after 6 hours).
次要结局
- Incidence of compilation(6 hours postoperatively)
- Time of post-operative ambulation(12 hours postoperatively)
- The time till first analgesic requirement(6 hours postoperatively)
- Total analgesics consumption(12 hours postoperatively)
研究者
Mostafa Serry
Captain Doctor, Resident of Obstetrics and Gynecology-The Police academy hospitals
Ain Shams University