Quadratus Lumborum Nerve Blocks in Laparoscopic Myomectomy Patients
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Morphine equivalents (MOE) consumption
研究概览
简要总结
This study would like to compare the use of the current standard of care in pain management for patients undergoing laparoscopic myomectomies to the addition of a quadratus lumborum nerve block plus the standard of care. Patients will be consented and the nerve blocks will be placed after the patients are placed under general anesthesia. Standard pain management will continue regardless of which arm of the study patients are in and measurements of pain scores, narcotic usage and abdominal numbness will be assessed in the post-operative period.
详细描述
This study aims to investigate benefits to the use of quadratus lumborum nerve blocks for laparoscopic myomectomies. Outcomes measured will be analgesic efficacy, incidence of post-operative events, patient satisfaction and narcotic usage.
Once a patient meets eligibility criteria and has consented to enter the study, randomization will be performed by the concealed envelope method. If chosen to be in the intervention group, a regional-trained anesthesiologist will perform the procedure, different from the intra-operative anesthesiologist. The control group will receive a superficial needle stick in the same location the quadratus lumborum block would have been otherwise placed.
Pre-operative protocol:
No premedications will be given while in the pre-operative waiting area. A member of the study group will randomly chose a concealed envelope indicating whether the patient will be in the control or intervention group.
Intraoperative protocol:
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
- None
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
- •American Society of Anesthesiologists (ASA) physical status 1-2,
- •greater than or equal to 18 years of age,
- •undergoing laparoscopic myomectomy surgery
排除标准
- •History of chronic pain requiring preoperative opioids,
- •congenital coagulopathy,
- •anatomic abnormalities,
- •localized soft tissue infection,
- •use of anticoagulants,
- •unable to comprehend pain scoring system,
- •severely obese (BMI > 35)
研究组 & 干预措施
Intervention
Standard of care pain management plus quadratus lumborum nerve block.
Ropivicaine 0.25% 60 mL will be injected in the fascial plane between the quadratus lumborum muscle and transverses abdominus muscle.
干预措施: Ropivacaine injection (Drug)
Control
Standard of care pain management plus a sham procedure.
干预措施: Sham treatment (Procedure)
结局指标
主要结局
Morphine equivalents (MOE) consumption
时间窗: Up to 24 hours after surgery
The patient's cumulative intake of morphine over 24 hours.
次要结局
- Pain Score(Up to 48 hours after surgery)
研究者
Natale Naim
Principal Investigator
University of California, Los Angeles