Efficacy of Intraperitoneal Versus Intravenous Lidocaine for Postcesarean Pain Relief
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Postoperative pain scoring (number)
研究概览
简要总结
Objective: To evaluate intraperitoneal (IP) lidocaine administration and intravenous (IV) lidocaine infusion for postoperative pain control after cesarean section.
Study design: prospective randomized, double-blind, placebo-controlled study. Patients and methods: Initially, 165 pregnant full-term females, indicated to be underwent elective cesarean delivery for various indications were randomized equally to either group C (control, IP and IV saline), group IP (intraperitoneal lidocaine administration), or group IV (intravenous lidocaine infusion).Five patients were excluded from each group for various reasons. The outcome measures were postoperative pain scoring, total pethidine consumption and the need for postoperative analgesia.
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
- •Singleton pregnancy, more than or equal completed 37 gestational weeks, indicated to undergo elective cesarean delivery for various indications
排除标准
- •extreme of age (below 18 or above 40 year), uncooperative patients, women under spinal anesthesia, previous abdominal scars, including previous cesarean or myomectomy, multiple gestation, BMI >35 kg/m², chorioamnionitis, hypersensitivity or contraindications to lidocaine, bronchial asthma, bleeding diathesis, pregnancy induced-hypertension, liver or kidney diseases, diabetes mellitus, and patients with psychological disturbance, or any form of chronic pain before or during pregnancy.
研究组 & 干预措施
Placebo control group
Saline was given both intraperitoneally and intravenously during caesarean section
干预措施: Intravenous normal saline (Drug)
Placebo control group
Saline was given both intraperitoneally and intravenously during caesarean section
干预措施: Intraperitoneal normal saline (Drug)
Intraperitoneal instillation group
Patients received 1.75 ml/kg of 0.2% lidocaine (3.5mg/kg) with parietal peritoneal closure with intravenous normal saline in a volume equivalent to that used in intravenous lidocaine group as placebo to ensure blinding.
干预措施: Intravenous normal saline (Drug)
Intraperitoneal instillation group
Patients received 1.75 ml/kg of 0.2% lidocaine (3.5mg/kg) with parietal peritoneal closure with intravenous normal saline in a volume equivalent to that used in intravenous lidocaine group as placebo to ensure blinding.
干预措施: Intraperitoneal Lidocaine (Drug)
Intravenous injection group
Patients received 1.5mg/kg of intravenous 1% lidocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lidocaine until one hour after surgery and 100 ml of saline intraperitoneally as placebo to ensure blinding
干预措施: Intraperitoneal normal saline (Drug)
Intravenous injection group
Patients received 1.5mg/kg of intravenous 1% lidocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lidocaine until one hour after surgery and 100 ml of saline intraperitoneally as placebo to ensure blinding
干预措施: Intravenous Lidocaine (Drug)
结局指标
主要结局
Postoperative pain scoring (number)
时间窗: First 24 hours postoperative
次要结局
- The need for rescue postoperative analgesia.(First 24 hours postoperative)
- Total pethidine consumption in 24 hours (mg)(First 24 hours postoperative)
- The time to bowel sounds, hours(First 3 days postoperative)
- The time to start regular diet, days(First 3 days postoperative)
- Duration of hospital stay , days(First 3 days postoperative)
- Any reported side effects(First 3 days postoperative)
研究者
Ahmed Walid Anwar Murad
Assistant Professor
Benha University