Comparison of Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 514
- 试验地点
- 2
- 主要终点
- VRS Pain Score
研究概览
简要总结
Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous Epidural Analgesia With Bupivacaine
详细描述
The investigator goal is to compare the analgesic efficacy of TAP blocks with liposomal bupivacaine (Exparel) and continuous epidural blocks in patients who are scheduled for major lower abdominal surgery. To assess whether TAP block with Exparel is noninferior to continuous epidural analgesia on pain management, defined as noninferior for both pain control and total opioid consumption for 72 hours, in patients who had major lower abdominal surgery.
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 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 abdominal surgery, including colorectal and hysterectomy surgeries
- •Anticipated hospitalization of 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 epidural or TAP blocks.
- •Surgeries with high port sites will be excluded
研究组 & 干预措施
TAP block with Exparel
Bilateral Transversus Abdominis Plane (TAP) block procedure following injection of liposomal bupivacaine (Exparel)
干预措施: TAP block (Procedure)
TAP block with Exparel
Bilateral Transversus Abdominis Plane (TAP) block procedure following injection of liposomal bupivacaine (Exparel)
干预措施: EXPAREL (Drug)
Epidural analgesia with Bupivacaine
Epidural catheters with an infusion of Bupivacaine standard solution without additives
干预措施: Epidural analgesia (Procedure)
Epidural analgesia with Bupivacaine
Epidural catheters with an infusion of Bupivacaine standard solution without additives
干预措施: Bupivacaine (Drug)
结局指标
主要结局
VRS Pain Score
时间窗: The Verbal Response Scale was recorded every 4 hours for 72 hours after discharge from the PACU.
Pain scores will be measured using a Verbal Response Scale (VRS). VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced. The VRS will be recorded every 4 hours for 72 hours after discharge from the PACU. Summary statistics of pain scores are reported as means ± standard deviations of average pain during the first 72 postoperative hours
Total Opioid Consumption
时间窗: During the 72 hours after discharge from the PACU.
Opioid consumption will be measured as the total amount of opioids (converted to morphine sulfate equivalents) used during the 72 hours after the end of surgery.
次要结局
- Hemodynamic Instability, Defined as Mean Arterial Pressure (MAP) <55 mmHg or Systolic Blood Pressure <80 mmHg.(Data was recorded at 15-s intervals during the initial 72 postoperative hours.)
- Length of Hospital Stay(From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 100 weeks)
- Cumulative Duration of Activity(During the initial 72 postoperative hours.)
- Opioid-related Side Effect(The first, second and third postoperative mornings)
- Quality of Recovery After Anesthesia(The first and third postoperative mornings)