Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 209
- 试验地点
- 1
- 主要终点
- Mean Pain Score
研究概览
简要总结
This study is prospective, randomized trial in which EXPAREL TAP block is compared to standard IT opioid administration, in relieving postoperative pain, decreasing length of stay, and use of narcotic medication.
详细描述
Primary Objective To assess efficacy of EXPAREL TAP blocks in improving pain scores for 48 hours postoperatively, and in reducing total oral morphine equivalents (OME) use, compared to standard Intrathecal opioid administration (IT).
Secondary Objective Assess the length of stay (LOS), postoperative ileus (POI) incidence, and the use of intravenous patient controlled analgesia (PCA) in patients that had EXPAREL TAP blocs compared to IT.
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
- All
- 接受健康志愿者
- 否
入选标准
- •• All patients undergoing elective laparoscopic or open colorectal resections who are eligible for IT
- •Age >18 years
- •Ability to understand and read English
排除标准
- •• Not able or unwilling to sign consent.
- •Currently pregnant or lactating.
- •Patients with chronic pain, requiring daily opiate use at time of surgery.
- •Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics.
- •Patients requiring emergent surgery.
- •Abdominoperineal resections
- •Any contraindications to neuraxial analgesia (coagulopathy, localized infection at the potential site of injection, pre-existing spinal canal pathology)
- •Patients with a diagnosis of inflammatory bowel disease
研究组 & 干预措施
TAP block (EXPAREL)
After induction of anesthesia, the patients will receive a single injection with 133 mg of EXPAREL in the transversus abdominis plane (TAP), on each side, suspended in 20 milliliters (mL) of injectable saline.
干预措施: EXPAREL (Drug)
Intrathecal opioid (IT)
single injection intrathecal hydromorphone analgesia given preoperatively
干预措施: Intrathecal hydromorphone (Drug)
结局指标
主要结局
Mean Pain Score
时间窗: First 48 hours post operative
Postoperative mean pain score for 48 hours after surgery. Pain was assessed on a 0 to 10 point visual analog scale (VAS), with 0 indicating no pain and 10 indicating severe pain. The mean pain score was summarized as the area under the curve (AUC) of the observed pain score, normalized for the total time of observation.
Total Morphine Milligram Equivalents Use (MME)
时间窗: First 48 hours post operative
The total cumulative use of opioids administered within 48 hours after surgery. MME is a standard value based on morphine and its potency assigned to all opioids to represent relative potencies.
次要结局
- Use of Intravenous Patient-controlled Analgesia(First 48 hours post-operative)
- Total Length of Hospital Stay(post-operative to discharge)
- Number of Participants With Post-operative Ileus(24 hours post-operatively)