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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Post-operative Narcotic Usage
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
0.125% Bupivacaine
0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
Intervention: Transversus Abdominis Plane (TAP) block (Procedure)
0.125% Bupivacaine
0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
Intervention: Nimbus Infusion Pump IV Administration (Device)
0.125% Bupivacaine
0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
Intervention: Bupivacaine infusion (Drug)
0.125% Bupivacaine
0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
Intervention: Acetominophen (Drug)
0.125% Bupivacaine
0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
Intervention: Hydromorphone (Drug)
0.125% Bupivacaine
0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
Intervention: Oxycodone (Drug)
0.125% Bupivacaine
0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
Intervention: Ondansetron (Drug)
Placebo
Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
Intervention: Transversus Abdominis Plane (TAP) block (Procedure)
Placebo
Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
Intervention: Nimbus Infusion Pump IV Administration (Device)
Placebo
Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
Intervention: Acetominophen (Drug)
Placebo
Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
Intervention: Hydromorphone (Drug)
Placebo
Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
Intervention: Oxycodone (Drug)
Placebo
Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
Intervention: Ondansetron (Drug)
Outcomes
Primary Outcomes
Post-operative Narcotic Usage
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Gordon Kwanlyp Lee
Professor of Surgery (Plastic and Reconstructive Surgery)
Stanford University