Quadratus Lumborum Block (QLB) for Pain Relief After Caesarean Section: A Prospective, Double-blind, Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- IV PCA Morphine consumption up to 24 hours.
研究概览
简要总结
There is currently a gap in the literature with regards to the utility of the QLB performed in conjunction with intrathecal morphine (ITM) for Caesarean section. The aim of the study is to assess the efficacy of the QLB as part of a multi-modal analgesic approach in patients after caesarean section.
详细描述
Post-operative pain relief management remains challenging after Caesarean-section. The perfect postoperative analgesic regimen is yet to be elucidated, but opioids remain a cornerstone whether they are administered intra-thecally, or systemically or both. Unfortunately, opioids are associated with significant adverse effects such as respiratory depression, post-operative nausea and vomiting (PONV), sedation and pruritus. Therefore, the search for opioid sparing analgesic techniques is important.
The study treatment consists of a quadratus lumborum block (QLB) of either 0.25% Levobupivacaine or a simulated sham QLB after C-section under spinal anaesthesia. The participants will be randomized into one of two groups with an internet based randomisation tool, and then allocated to either group as per the allocation in a sealed opaque envelope.
Spinal anaesthesia will be performed in a standardised manner using 10-15mg hyperbaric bupivacaine, 20ug fentanyl and 100ug preservative free morphine. Anaesthetic and surgical management will be conducted as per the usual manner. Diclofenac 100mg suppositories and IV Paracetamol 1g will be administered at the end of surgery. A Morphine PCA will be connected to the patient in the recovery room after the intervention.
The bilateral posterior QLB will be performed after surgery in the supine position in an aseptic manner. The patient will be blinded to the group intervention as the sterile drapes will be left hanging blocking the patient's view of the procedure. The block from the spinal anaesthetic will mean the patient is unaware of the procedure being carried out. A curvilinear ultrasound probe will be used to identify the quadratus lumborum muscle.
Intervention group:
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, 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
- •Elective Caesarean section under spinal anaesthesia.
- •Age > 18 years old.
- •Singleton pregnancy.
排除标准
- •Contraindication to spinal or regional anaesthesia.
- •Allergy/sensitivity/contraindication to study medications.
- •Unable to comprehend visual analogue scale.
- •Booking weight <40kg.
- •History of chronic pain or regular opioid use.
- •Pre-eclampsia.
研究组 & 干预措施
Quadratus lumborum block
Bilateral posterior QLB with 20ml 0.25% L-Bupivacaine.
干预措施: Quadratus lumborum block (Procedure)
Sham QLB
Sham QLB - Ultrasound identification of QLB followed by skin pressure with blunt needle. Patient blinded due to residual spinal anaesthetic block.
干预措施: Sham QLB (Procedure)
结局指标
主要结局
IV PCA Morphine consumption up to 24 hours.
时间窗: 24 hours
Intravenous PCA (patient controlled analgesia) morphine consumption up to 24 hours.
次要结局
- Pain scores at rest.(6, 12, 24, 48 hours)
- Pain scores on movement.(6, 12, 24, 48 hours)
- Nausea and vomiting.(24, 48 hours)
- IV PCA morphine bolus demands.(24 hours)
- Total opioid consumption at 48 hours.(48 hours)
- QbsQoR-11.(24, 48 hours)
- QoR-15.(24, 48 hours)
研究者
Ruairi Irwin
Principal investigator
Coombe Women and Infants University Hospital