Quadratus Lumborum Blocks for Pain Control Following Open Ventral Hernia Repair: A Double Blinded Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Post-operative Opioid Utilization
研究概览
简要总结
The purpose of this study is to determine whether using a QL block is better than placebo (a look-alike substance that contains no drug) in lowering the amount of opioids you need for pain relief in the first 24 hours and if it improves your recovery following a ventral hernia repair.
Participants will be asked to complete a questionnaire before surgery and again at their 30-day follow up. You will also be asked to complete a pain diary 24 hours after surgery and attend a follow-up visit approximately 30 days after surgery.
The following information will be collected from you or your medical record:
- Pain medications given to you during surgery.
- Pain medications prescribed to you after surgery, including medication name, dose, units, and frequency.
- Pain levels during the first 24 hours after surgery.
- Your total hospital length of stay after surgery.
- Any complications that you may have experienced after surgery.
- Demographic information, medical history as well as details about your hernia repair surgery.
详细描述
Quadratus Lumborum (QL) blocks have provided analgesia for abdominal surgery. These blocks involve ultrasound-guided local anesthetic injection deep into the anterior fascia of the quadratus lumborum into the thoracolumbar fascia, resulting in widespread abdominal and pelvic pain control. QL blocks extend that coverage from T4 to L1 in the paravertebral space. At this local institution, QL blocks have demonstrated the ability to provide complete sensory analgesia for most patients from T9-L1 up to an estimated 17 hours after surgery. Therefore the goal of this study is to evaluate the effectiveness of QL block in this patient population.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years of age
- •Able to read and understand study procedures
- •Willing to participate and sign an informed consent form
- •Open approaches to ventral hernia repair
- •Clean (CDC Class I), clean-contaminated (CDC Class II)
- •Elective surgery
- •Mesh placed in the retromuscular position
排除标准
- •Dirty-Infected cases (CDC Class IV): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera
- •Patient has a contraindication to receiving the drug and/or procedure: allergy/sensitivity to the drug, coagulopathy, abdominal wall infection at the drug administration site, systemic infection, anatomical distortion, neuropathy
- •Emergent procedure
- •Mesh not placed
研究组 & 干预措施
Control
The control (placebo comparator) group will undergo the same QL block procedure as the intervention arm, except saline (placebo) will be injected.
干预措施: Placebo (Procedure)
Quadratus Lumborum Block
The Quadratus Lumborum block will be randomly administered to half of the study patients.
干预措施: Quadratus Lumborum (QL) Block (Procedure)
结局指标
主要结局
Post-operative Opioid Utilization
时间窗: From the time of treatment until 24 hours after surgery
Quantity of Post-Operative Opioid Consumption as Measured by Morphine Milliequivalents for 24 Hours After Surgery
次要结局
- Numerical rating Pain Score(From the time of treatment through hospitalization completion, an average of 4 days.)