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Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA

NCT02601027 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-09-23

Study results available
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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.

Conditions

  • Breast - Female

Interventions

PROCEDURE

Transversus Abdominis Plane (TAP) block

DEVICE

Nimbus Infusion Pump IV Administration

DRUG

Bupivacaine infusion

DRUG

Acetominophen

DRUG

Hydromorphone

DRUG

Oxycodone

DRUG

Ondansetron

Sponsors & Collaborators

Principal Investigators

  • Gordon K Lee, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2019-09-07
Completion
2021-06-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02601027 on ClinicalTrials.gov