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

August 28, 2021 updated by: Gordon Kwanlyp Lee, Stanford University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

  • Prior diagnosis or presumed diagnosis of breast cancer or undergoing prophylactic treatment.
  • Greater than 18 years old.
  • Female.
  • Undergoing microsurgical breast reconstruction with abdominal free flap.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

  • True allergy to local anesthetics or opioids.
  • History of addiction to narcotics within the last 24 months
  • History of chronic pain on opioids within the last 24 months.
  • Specific mental health issues such as schizophrenia or bipolar disorder.
  • Patients who are pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.125% Bupivacaine
0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
Drug: Hydromorphone
Other Names:
  • Dilaudid
  • Exalgo
  • Dilaudid-HP
Procedure: Transversus Abdominis Plane (TAP) block
Device: Nimbus Infusion Pump IV Administration
Drug: Bupivacaine infusion
Other Names:
  • Marcaine
  • Exparel
  • Sensorcaine
  • Marcaine Spinal
  • Sensorcaine-MPF
  • Sensorcaine-MPF Spinal
  • ReadySharp bupivacaine
  • P-Care M
Drug: Acetominophen
Other Names:
  • Tylenol
Drug: Oxycodone
Other Names:
  • Oxycontin
  • Roxicodone
  • Xtampza ER
  • Oxaydo
Drug: Ondansetron
Other Names:
  • Zofran
  • Zofran ODT
  • Zuplenz
Placebo Comparator: Placebo
Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
Drug: Hydromorphone
Other Names:
  • Dilaudid
  • Exalgo
  • Dilaudid-HP
Procedure: Transversus Abdominis Plane (TAP) block
Device: Nimbus Infusion Pump IV Administration
Drug: Acetominophen
Other Names:
  • Tylenol
Drug: Oxycodone
Other Names:
  • Oxycontin
  • Roxicodone
  • Xtampza ER
  • Oxaydo
Drug: Ondansetron
Other Names:
  • Zofran
  • Zofran ODT
  • Zuplenz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Pain Score
Time Frame: 2 days
Post-operative Pain Score is defined using Visual Analog Scale (VAS), a patient-reported pain score based on viewing a graphic of a scale 0 to 10, and indicating pain level. Each participant was asked about 48 hours after breast reconstruction to indicate their their perceived pain according on the VAS scale. Higher scores represent greater pain. The outcome is reported as the mean VAS score at 48 hours, with standard deviation.
2 days
Post-operative Anti-emetic Usage
Time Frame: 48 hours
Odansetron by intravenous administration was used to control nausea (ie, an anti-emetic drug). Anti-emetic usage was collected for first 48 hours post-operatively after breast reconstruction for the group receiving transversus abdominis plane (TAP) nerve block compared to the group receiving the placebo control. The outcome is reported as the mean quantity of Odansetron in milligrams (mg) administered to each group, with standard deviation.
48 hours
Time to Ambulation
Time Frame: up to 1 week
Time to ambulation is defined as the amount of time, from midnight on post-operative Day 1 (ie, first midnight following the surgery), to when the participant to be able to stand up and walk a few steps post-operatively. The assessment of whether or not the participant was able to walk was subjective on the part of the shift nurse (ie, no defined number of steps nor quantitative assessment of gait or stability), and was not explicitly defined in the protocol or elsewhere. The outcome is reported as the time to ambulation in days, with standard deviation, for the group receiving transversus abdominis plane (TAP) nerve block and the group receiving the placebo control.
up to 1 week
Time to First Bowel Movement
Time Frame: up to 1 week
Time to first bowel movement is defined as the amount of time, from midnight on post-operative Day 1 (ie, first midnight following the surgery), to when the participant was to be able to pass a stool post-operatively. The outcome is reported as the time in days, with standard deviation, for the group receiving transversus abdominis plane (TAP) nerve block and the group receiving the placebo control.
up to 1 week
Quality of Life Measurement
Time Frame: Pre-operative Baseline and Post-operative (2-6 months)
Quality of life for the study groups was assessed with the BREAST-Q questionnaire, a survey set of 6 pre-operative questionnaires comprised of 58 questions, and 15 post-operative questionnaires, collected 2 to 6 months after surgery, which is comprised of 109 questions. The results range for the pre-operative and post-operative questionnaire sets is 0 to 269 and 0 to 462, respectively. Because the baseline and post-operative domains are different, the BREAST-Q survey is not a measure of quality of life change over time. The Breast Q questionnaire was validated by Pusic, et al (citation provided). Higher scores for a domain represents better quality of life. The outcome is reported as the mean for each group and timepoint, with standard deviation.
Pre-operative Baseline and Post-operative (2-6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Gordon K Lee, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

September 7, 2019

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (Estimate)

November 10, 2015

Study Record Updates

Last Update Posted (Actual)

September 23, 2021

Last Update Submitted That Met QC Criteria

August 28, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-34315
  • BRS0058 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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