Quadratus Lumborum Block Versus Intrathecal Morphine for Prevention of Chronic Post-Caesarean Pain: A Four-Arm Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Chronic pain incidence at 6monthes
研究概览
简要总结
The aim of this study is to compare the incidence of CPSCP in patients receiving QLB quadratus lumborum block and ITM versus control as a primary outcome and associated risk factors that might predispose patients to develop CPSCP.
详细描述
The aim of this study is to compare the incidence of chronic post cesarean pain in patients receiving quadratus laborum block and and intrathecal morphine versus control as a primary
Study design:
Patients will be randomly allocated to the procedure through closed envelopes and so syringes and medication will be prepared and labelled by anesthetist other than the anesthetist giving the block Patients will be randomly allocated to the procedure through closed envelopes and so syringes and medication will be prepared and labelled by anesthetist other than the anesthetist giving the block Data will be collected regarding the demographic data, gestational stage, parity and number of previous cesarean section, previous abdominal surgeries, and narcotic consumption.
Postoperative pain day 1 and day2 will be followed by anesthetist who is blinded to the applied technique used. Follow up for the subsequent period of observation (2,4and 6 months) will be done by a blinded research nurse who will contact the patients by phone to ask them if there is any "concern" after the operation. If the patient refers to a pain at the surgical site that has been lasting for the past three months a call will be conducted by the anesthetist and a referral schedule will be appointed to the pain clinic consultant for further evaluation
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 (Care Provider, Outcomes Assessor)
盲法说明
Patients will be randomly allocated to the procedure through closed envelopes and so syringes and medication will be prepared and labelled by anesthetist other than the anesthetist giving the block
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •patients admitted to the operating theatre for elective caesarean section
排除标准
- •lack of informed consent
- •Allergy to drugs used during the study
- •Depression and epilepsy that required antidepressants or anticonvulsants
- •known coagulopathy as a contraindication for spinal anesthesia
研究组 & 干预措施
Group QM
Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg combined by QLB of 30 ml 0.125%bupivacain
干预措施: intrathecal bupivacaine (Drug)
Group QM
Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg combined by QLB of 30 ml 0.125%bupivacain
干预措施: Intrathecal morphine (Drug)
Group M
Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg
干预措施: intrathecal bupivacaine (Drug)
Group Q
QLB group will receive 30 ml 0.125% bupivacaine (Sunnypivacaine by Sunny Pharmaceuticals) for each side
干预措施: Quadratus laborum block (Procedure)
Group Q
QLB group will receive 30 ml 0.125% bupivacaine (Sunnypivacaine by Sunny Pharmaceuticals) for each side
干预措施: intrathecal bupivacaine (Drug)
Group QM
Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg combined by QLB of 30 ml 0.125%bupivacain
干预措施: Quadratus laborum block (Procedure)
Group C
Control group with intrathecal bupivacaine 0.5% 15mg and fentanyl 20 µg.
干预措施: intrathecal bupivacaine (Drug)
Group M
Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg
干预措施: Intrathecal morphine (Drug)
结局指标
主要结局
Chronic pain incidence at 6monthes
时间窗: Six months
Pain at six monthes
次要结局
- Visual analogue scale(48 hours)
研究者
rabab Mohammad habeeb
Principal investigator
Menoufia University