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

Stanford University1 site in 1 country120 target enrollmentNovember 2015

InterventionsTransversus Abdominis Plane (TAP) block Nimbus Infusion Pump IV Administration Bupivacaine infusion Acetominophen Hydromorphone Oxycodone Ondansetron

DrugsBupivacaine infusion Acetominophen Hydromorphone Oxycodone Ondansetron

Overview

Phase: Phase 3
Intervention: Transversus Abdominis Plane (TAP) block
Conditions: Breast - Female
Sponsor: Stanford University
Enrollment: 120
Locations: 1
Primary Endpoint: Post-operative Narcotic Usage
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

November 2015

End Date

June 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Stanford University

Responsible Party

Principal Investigator

Gordon Kwanlyp Lee

Professor of Surgery (Plastic and Reconstructive Surgery)

Stanford University

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Intervention: Oxycodone

Placebo

Saline infusion (sham) via transversus abdominis plane (TAP) catheter.

Intervention: Ondansetron

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)