NCT04397458撤回4 期
Rescue Quadratus Lumborum Blocks for Post-cesarean Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Total opioid consumption
研究概览
简要总结
The purpose of this study is to assess whether quadratus lumborum (QL) block performed 1 day after cesarean delivery will provide supplemental post-cesarean analgesia and reduce opioid requirements.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •elective or non-elective cesarean delivery on prior day
- •pain scores >5/10
排除标准
- •obstructive sleep apnea
- •drug abuse
- •chronic pain
- •chronic opioid use
- •abdominal surgeries other than cesarean delivery
- •contraindications to neuraxial or regional anesthesia
- •received general anesthesia or did not receive neuraxial morphine for cesarean delivery
研究组 & 干预措施
Sham Control
Sham Comparator
20 milliliters (mL) 0.9% saline on each side
干预措施: Saline (Drug)
Quadratus Lumborum Block
Experimental
20 mL solution with 0.25% bupivacaine (50 milligrams (mg)) and 3mg preservative-free dexamethasone on each side
干预措施: Bupivacaine (Drug)
Quadratus Lumborum Block
Experimental
20 mL solution with 0.25% bupivacaine (50 milligrams (mg)) and 3mg preservative-free dexamethasone on each side
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Total opioid consumption
时间窗: 48 hours after intervention
次要结局
- Pain as measured by an 11-point verbal pain score (at rest)(48 hours after intervention)
- Pruritus as measured by a 3-point scale(48 hours after intervention)
- Nausea, pruritus and sedation as measured by a 3-point scale(24 hours after intervention)
- Time from quadratus lumborum block until first opioid request(from time of intervention until time of first opioid request (up to 48 hours))
- Pain as measured by an 11-point verbal pain score (with movement)(48 hours after intervention)
- Sedation as measured by a 3-point scale(48 hours after intervention)
- Amount of opioids used(48 hours after intervention)
- Nausea as measured by a 3-point scale(48 hours after intervention)
- Patient satisfaction as measured by the 5-point Likert scale(48 hours after intervention)
研究者
Maya Suresh
Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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