A Randomized Controlled Trial Comparing Intrathecal Morphine With Quadratus Lumborum Block as Part of a Multimodal Analgesia Strategy for Post-cesarean Delivery Analgesia
试验速览
- 阶段
- 不适用
- 发起方
- Vishal Uppal
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Quality of recovery (QoR) score
研究概览
简要总结
Pain after caesarean delivery (CD) can interfere with the moms' ability to look after her baby and may contribute to developing long term pain and disability. Women having a CD receive pain medication (morphine) as part of their spinal anesthetic to help with pain relief after surgery. Morphine works well however has several side effects such as nausea, vomiting and itching which may be severe enough to make it difficult to care for herself and her new baby. In some cases, morphine causes difficulty in passing urine within first 24-hours of the CD requiring catheterization and thus restricting mobilization. The quadratus lumborum block (QLB) is a newer nerve block that uses local anaesthetic solution to numb the nerves carrying pain sensation from surgical incision site. QLB may be able to provide effective pain control without the side-effects associated with the spinal morphine. This study is to determine if women receiving QLB have as good pain control with fewer side effects than those who do receive the spinal morphine. Adequate pain control will be assessed by their pain scores and recovery in the 24 to 48 hours after CD. The side effect profile of the two techniques, quality of recovery and long term impact will also be compared during this study.
In addition, we would like to compare the patients who received both analgesic regimens (ITM and QLB) with patients who received only one analgesic intervention (i.e. either ITM or QLB). Further, the study will help us answer if combining the two analgesic interventions if beneficial or not.
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
- Quadruple (Participant, Care Provider, 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
- •Non-emergent CD with planned spinal anesthesia
- •American Society of Anesthesia physical status class I & II;
- •Age ≥18 years;
- •Term gestational age (≥37 weeks);
- •Singleton pregnancy;
- •English-speaking.
排除标准
- •Morbid Obesity (BMI ≥35 kg/m2);
- •Subjects with significant obstetric or neonatal co-morbidities;
- •Patient enrollment in another study involving medication within 30 days of CD;
- •Any other condition, which may impair patients ability to co-operate with data collection;
- •Patient height less than 152 cm (5'0");
- •History of opioid tolerance or sensitivity;
- •Intolerance to non-steroidal anti-inflammatory drugs (NSAIDs);
- •Women with a history of illicit drug use or prescribed opioids or benzodiazepines.
结局指标
主要结局
Quality of recovery (QoR) score
时间窗: 24 hours
次要结局
- Quality of recovery (QoR) score(48 hours)
- Incidence of nausea/vomiting needing treatment(24 hours)
- Incidence of itching needing treatment.(24 hours)
- Morphine equivalent consumption(24 hours and 48 hours)
- Incidence of respiratory depression needing treatment.(24 hours)
- Worst pain scores(24 hours)
研究者
Vishal Uppal
Anesthesiologist
Nova Scotia Health Authority