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

Phase 3

Completed

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

Registration Number: NCT02601027

Lead Sponsor: Stanford University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.125% Bupivacaine	Transversus Abdominis Plane (TAP) block	0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
0.125% Bupivacaine	Nimbus Infusion Pump IV Administration	0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
0.125% Bupivacaine	Bupivacaine infusion	0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
0.125% Bupivacaine	Acetominophen	0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
0.125% Bupivacaine	Hydromorphone	0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
0.125% Bupivacaine	Oxycodone	0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
0.125% Bupivacaine	Ondansetron	0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
Placebo	Transversus Abdominis Plane (TAP) block	Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
Placebo	Nimbus Infusion Pump IV Administration	Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
Placebo	Acetominophen	Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
Placebo	Hydromorphone	Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
Placebo	Oxycodone	Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
Placebo	Ondansetron	Saline infusion (sham) via transversus abdominis plane (TAP) catheter.

Primary Outcome Measures

Name	Time	Method
Post-operative Narcotic Usage	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 Outcome Measures

Name	Time	Method
Time to Ambulation	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.
Post-operative Pain Score	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.
Post-operative Anti-emetic Usage	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.
Quality of Life Measurement	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.
Time to First Bowel Movement	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.