Comparison of Intrathecal Morphine With Quadratus Lumborum Block for Post-Cesarean Delivery Analgesia:
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Pain on movement at 12 hrs after surgery
研究概览
简要总结
Most women having planned cesarean section receive spinal anesthetic for the procedure.
Typically, spinal opioids are administered during the same time as a component of multimodal analgesia to provide pain relief in the 16-24 hr period postoperatively. However, spinal opioids are frequently associated with adverse effects such as nausea, pruritus, sedation and occasionally respiratory depression.
The quadratus lumborum (QL) block is a regional analgesic technique which blocks T5-L1 nerve branches and has an evolving role in postoperative analgesia for lower abdominal surgeries and is a potential alternative to spinal opioids. There is some evidence that it may provide visceral along with somatic pain relief. It is a simple and safe technique that has been studied in lower abdominal surgeries, but has not been studied for pain relief after cesarean section.
If found effective, it will have the advantage of a reduction in opioid associated adverse effects while providing similar quality of analgesia. This block has evolved from the previously known transversus abdominis plane block.
We propose to undertake a study that will compare the relative efficacy of QL block with local anesthetic to spinal morphine. We will also study if it provides any incremental benefit when administered in addition to spinal morphine.
详细描述
This will be a randomized controlled double blinded trial.
Seventy five female patients belonging to American Society of Anesthesiologists status 1-3, age 18-45 yrs undergoing elective caesarean delivery will be included in this prospective study.
After obtaining informed consent, they will be randomized to one of the three groups by a computer-generated randomization. All patients will receive standard spinal anesthetic. They will be randomized to one of the three groups (n=25 per group).
Groups 1 and 3 will receive intrathecal morphine in addition to the spinal anesthestic. Group 2 will receive equal volume of saline added to the intrathecal mixture.
Ultrasound guided Quadratus Lumborum block will be done. Following negative aspiration, 25 mL of Ropivacaine 0.5% (Groups 2 and 3), or the same amount of saline (Group 1) will be injected in each side.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Elective cesarean delivery
- •American Society of Anesthesiologists Physical Status 1-3
- •Suitable for procedure to be carried out under spinal anesthesia
排除标准
- •Inability to give informed consent or to co-operate with post-operative evaluation
- •Allergy to local anesthetics, morphine, fentanyl, ropivacaine
- •Ongoing major medical or psychiatric problems
- •Chronic opioid use
- •Major coagulopathy
- •BMI>35 on first ante natal visit
- •Pre-eclampsia
- •Contraindication to neuraxial anesthesia
研究组 & 干预措施
Group 1
Group 1 will receive intrathecal morphine co-administered with the spinal anesthetic. After the completion of surgery, bilateral ultrasound guided Sham Block be done with 25 mL of saline per side.
干预措施: Sham Block (Procedure)
Group 1
Group 1 will receive intrathecal morphine co-administered with the spinal anesthetic. After the completion of surgery, bilateral ultrasound guided Sham Block be done with 25 mL of saline per side.
干预措施: Intrathecal Morphine (Drug)
Group 2
Group 2 will receive an equivalent volume of intrathecal saline co-administered with the spinal anesthetic. After surgery, bilateral ultrasound guided Quadratus Lumborum Block will be performed with 25 ml 0.5% Ropivacaine per side.
干预措施: Quadratus Lumborum Block (Procedure)
Group 2
Group 2 will receive an equivalent volume of intrathecal saline co-administered with the spinal anesthetic. After surgery, bilateral ultrasound guided Quadratus Lumborum Block will be performed with 25 ml 0.5% Ropivacaine per side.
干预措施: Intrathecal Saline (Drug)
Group 3
Group 3 will receive will receive intrathecal morphine with the spinal anesthetic. After the completion of surgery, bilateral ultrasound guided Quadratus Lumborum Block will be performed with 25 ml 0.5% Ropivacaine per side.
干预措施: Quadratus Lumborum Block (Procedure)
Group 3
Group 3 will receive will receive intrathecal morphine with the spinal anesthetic. After the completion of surgery, bilateral ultrasound guided Quadratus Lumborum Block will be performed with 25 ml 0.5% Ropivacaine per side.
干预措施: Intrathecal Morphine (Drug)
结局指标
主要结局
Pain on movement at 12 hrs after surgery
时间窗: 12 hours
Numeric Rating Scale to evaluate pain scores at 12 h after surgery.
次要结局
- Nausea at 6, 12, 24 hrs after surgery(24 hours)
- Chronic Wound Pain at 6 weeks(6 weeks)
- Pruritus at 6, 12, 24 hrs after surgery(24 hours)
- Pain and Morphine consumption at 6,12 24 hrs after surgery.(24 hours)