A Phase III Study of Pre-operative Transversus Abdominis Plane Blocks Using the Nimbus Ambulatory Infusion System in Patients Undergoing Abdominal Free Flap-based Breast Reconstruction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Post-operative Narcotic Usage
研究概览
简要总结
The primary objective is to determine if pre-operative transversus abdominis plane (TAP) nerve blocks by continued infusion of local anesthetic post-operatively affects post-operative narcotic usage, as compared to a placebo TAP block, after breast reconstruction surgery.
详细描述
Primary Objective: The primary objective is to determine if pre-operative transversus abdominis plane (TAP) blocks with continued infusion of local anesthetic post-operatively affect post-operative narcotic usage as compared to a placebo TAP block.
Secondary Objectives:
- Determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect post-operative pain scores as compared to a placebo TAP block.
- Determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect anti-emetic usage as compared to a placebo TAP block.
- Determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect time to ambulation post-operatively as compared to a placebo TAP block.
- Determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect time to first bowel movement as compared to a placebo TAP block.
- Determine if pre-operative TAP blocks with continued infusion of local anesthetic post-operatively affect patient-reported quality of life as compared to a placebo TAP block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
0.125% Bupivacaine
0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
干预措施: Transversus Abdominis Plane (TAP) block (Procedure)
0.125% Bupivacaine
0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
干预措施: Nimbus Infusion Pump IV Administration (Device)
0.125% Bupivacaine
0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
干预措施: Bupivacaine infusion (Drug)
0.125% Bupivacaine
0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
干预措施: Acetominophen (Drug)
0.125% Bupivacaine
0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
干预措施: Hydromorphone (Drug)
0.125% Bupivacaine
0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
干预措施: Oxycodone (Drug)
0.125% Bupivacaine
0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
干预措施: Ondansetron (Drug)
Placebo
Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
干预措施: Transversus Abdominis Plane (TAP) block (Procedure)
Placebo
Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
干预措施: Nimbus Infusion Pump IV Administration (Device)
Placebo
Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
干预措施: Acetominophen (Drug)
Placebo
Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
干预措施: Hydromorphone (Drug)
Placebo
Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
干预措施: Oxycodone (Drug)
Placebo
Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
干预措施: Ondansetron (Drug)
结局指标
主要结局
Post-operative Narcotic Usage
时间窗: 48 hours
Narcotic usage was collected for first 48 hours post-operatively after breast reconstruction. The type and amount of each narcotic administered were each converted to the morphine equivalent amount that would be orally administered to achieve the same event. This term is known as the oral morphine equivalent (OME). Narcotic usage was assessed between the group receiving transversus abdominis plane (TAP) nerve block compared to the group receiving the placebo control. The outcome is reported as the observed OME for each group.
次要结局
- Time to Ambulation(up to 1 week)
- Post-operative Pain Score(2 days)
- Post-operative Anti-emetic Usage(48 hours)
- Quality of Life Measurement(Pre-operative Baseline and Post-operative (2-6 months))
- Time to First Bowel Movement(up to 1 week)
研究者
Gordon Kwanlyp Lee
Professor of Surgery (Plastic and Reconstructive Surgery)
Stanford University