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OpenTrials
Completed

NCT Number: NCT02601027

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Stanford University Medical Center

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transversus abdominis plane (TAP) block

Procedure

Nimbus Infusion Pump IV Administration

Device

Bupivacaine infusion

Drug

Other names: Exparel, Marcaine, Marcaine Spinal, Sensorcaine, Sensorcaine-MPF, Sensorcaine-MPF Spinal, ReadySharp bupivacaine, P-Care M

Acetominophen

Drug

Other names: Tylenol

Hydromorphone

Drug

Other names: Dilaudid, Dilaudid-HP, Exalgo

Oxycodone

Drug

Other names: Oxycontin, Xtampza ER, Oxaydo, Roxicodone

ondansetron

Drug

Other names: Zofran, Zofran ODT, Zuplenz

Primary outcomes

  1. 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

  1. 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. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2021
First posted
Nov 10, 2015
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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