Double-Blinded Randomized Control Trial Comparing Liposomal Bupivacaine and Bupivacaine Hydrochloride in Transversus Abdominis Plane Blocks Prior To DIEP Flap for Breast Reconstruction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)
研究概览
简要总结
This study will compare the efficiency of transversus abominus plane (TAP) block using liposomal bupivacaine versus plain bupivacaine that is administered in the operating room under ultrasound guidance prior to the in patients undergoing abdominally-based free flap breast reconstruction at Vanderbilt University Medical Center.
详细描述
Transversus Abdominis Plane (TAP) blocks are commonly used as part of Enhanced Recovery After Surgery (ERAS) pathway. This prospective, double-blinded, randomized control trial compares post-operative pain and narcotic consumption after deep inferior epigastric artery perforator (DIEP) breast reconstruction with liposomal bupivacaine (LB) compared to bupivacaine hydrochloride (BHCl). Subjects undergoing DIEP flaps were randomly assigned LB or BHCl, performed using ultrasound-guided TAP block technique pre-procedurally. Primary outcomes were postoperative narcotic analgesia required in oral morphine equivalents (OME) from postoperative day (POD) 0 to 7. Secondary outcomes included POD 1-7 pain Numeric Rating Scale (NRS), non-narcotic pain medication consumption, time to first narcotic use, return of bowel function, and length of stay (LOS).
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
- Double (Participant, Care Provider)
盲法说明
Participants and plastic surgeons will be blinded to the study treatment arm
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
- •age between 18-85 years
- •males or females
- •plastic surgery for abdominally-based free flap breast reconstruction.
排除标准
- •those not candidates for TAP blocks due to allergies to the medications (e.g., bupivacaine)
- •those with anatomic contra-indications to performing a TAP block
- •those unwilling to participate in follow-up assessments
- •vulnerable populations
- •chronic pain or associated diagnosis
研究组 & 干预措施
TAP block with liposomal bupivacaine
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
干预措施: Liposomal bupivacaine (Drug)
TAP block with regular bupivacaine
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.
干预措施: Regular bupivacaine (Drug)
结局指标
主要结局
Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)
时间窗: Postoperative day (POD) 1 to 7
Amount of supplemental postoperative narcotic analgesia (both intravenous and oral) required by study groups in oral morphine equivalents
次要结局
- Ambulation(1 day post op)
- Non-narcotic Pain Medication Intake: Acetaminophen(Post op day 1 to 7)
- Time to Return of Bowel Function(1 to 4 days post operation)
- Non Narcotic Pain Medication Intake: Cyclobenzaprine(Post op day 1 to 7)
- Pain Measure(Post operative day (POD) 1 to 7)
- Time to First Opiate Use(0-29.8 hours post operation)
- Length of Stay(1 to 4 days)
- Non Narcotic Pain Medication Intake: Celebrex(post op day 1 to 7)
- Non Narcotic Pain Medication Intake: Gabapentin(Post op day 1 to 7)
- Non Narcotic Pain Medication Intake: Ondansetron(Post op day 1 to 7)
研究者
Galen Perdikis
Chair and Professor of Surgery Department of Plastic Surgery
Vanderbilt University Medical Center