Comparison of Liposomal Bupivacaine, Plain Bupivacaine, and Placebo for Transversus Abdominis Plane Blocks: A Randomized, Blinded Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 285
- 试验地点
- 1
- 主要终点
- Total Opioids During Postoperative 24 Hours
研究概览
简要总结
The study will prospectively compare the analgesic efficacy of TAP blocks with liposomal bupivacaine, plain bupivacaine, and placebo in patients who are scheduled for major abdominal surgery. The primary aim is to assess the duration of the local analgesia (determined by pinprick and cold) in all four quadrants. Comparing opioid consumption and pain scores is a secondary aim. All aims will be assessed over 72 hours or the duration of hospitalization if shorter.
详细描述
The investigators propose a randomized double-blind trial comparing TAP blocks with liposomal bupivacaine, plain bupivacaine, and placebo in patients having elective abdominal surgery.
After eligibility is confirmed, patients will receive complete information about the study both verbally and in writing. Informed consent will be obtained from the patients prior to randomization and study-specific procedures.
Randomization will be based on computer-generated codes and use random-sized blocks. Allocations will be concealed until the morning of surgery where they will be provided by a web-based system. Randomization will be stratified by study site and chronic opioid use, defined by opioid use for more than 30 consecutive days within three preoperative months, at a daily dose of 15 mg or more of morphine or equivalent. Randomization will also be stratified according to anticipated type of surgery (open vs. laparoscopic-assisted). Clinicians doing the blocks will not be involved in data collection and all the evaluators will be blinded to group allocations.
All blocks will be performed preoperatively or after induction of anesthesia by attending anesthesiologists or regional anesthesia fellows who are experienced in TAP blocks. Premedication will be administered at the discretion of the attending anesthesiologist and standard monitors will be used. Patients will be given 1 g oral acetaminophen an hour before surgery, and an additional 500 mg every 6 hours for 72 hours after surgery starting with oral intake.
Patients will be randomly assigned to: 1) 4-quadrant TAP block with liposomal bupivacaine; 2) 4-quadrant TAP block with plain bupivacaine; or, 3) placebo (normal saline). An in-plane ultrasound will be guide TAP blocks. Two subcostal injections will be applied by placing the probe midline and then moving lateral along the subcostal margin identifying area between the rectus abdominis sheath and the transversus abdominis muscle. The lateral two TAP block injections will be applied in the midaxillary line between the thoracic cage and iliac crest between external oblique and transversus abdominis muscles. Once the target area is positioned, the following injections will be given, based on randomization:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent;
- •18-85 years old;
- •ASA Physical Status 1-3;
- •Scheduled for elective open or laparoscopic-assisted abdominal surgery;
- •Anticipated hospitalization of at least three nights;
- •Expected requirement for parenteral opioids for at least 72 hours for postoperative pain;
- •Able to use IV PCA systems.
排除标准
- •Hepatic disease, e.g. twice the normal levels of liver enzymes;
- •Kidney disease, e.g. twice the normal level of serum creatinine;
- •Bupivacaine sensitivity or known allergy;
- •Women who are pregnant or breastfeeding;
- •Anticoagulants considered to be a contraindication for TAP blocks;
- •Surgeries with high port sites;
- •Weight <50 kg.
研究组 & 干预措施
liposomal bupivacaine
40 ml of plain bupivacaine 0.25% will be mixed with 20 ml liposomal bupivacaine and 20 ml of saline. 20 ml of the mix will be injected at each location of the 4-quadrant TAP block.
干预措施: Liposomal bupivacaine (Drug)
plain bupivacaine
50 ml of plain bupivacaine 0.5% will be combined with 30 ml of normal saline making a total of 80 ml. 20 ml will be injected at each location of the 4-quadrant TAP block.
干预措施: Plain bupivacaine (Drug)
Normal Saline
patients will receive total of 80 ml of normal saline, injected 20 ml in each of the four-quadrant sites.
干预措施: Normal saline (Drug)
结局指标
主要结局
Total Opioids During Postoperative 24 Hours
时间窗: Postoperative 24 hours
Opioid consumption, measured in morphine milligram equivalents, during the first 24 hours of surgery
Total Opioid Consumption During Postoperative 24 to 48 Hours
时间窗: Postoperative 24 to 48 hours
Total opioid consumption, in morphine milligram, equivalents, during postoperative 24 to 48 hours.
次要结局
- Time to Return of Sensation(72 hours)
- Pain Scores During Postoperative 72 Hours(Postoperative 72 hours)
- Total Opioid Consumption (Postoperative 48 to 72 Hours)(Postoperative 48 to 72 hours)