Trial Outcomes & Findings for Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA (NCT NCT02601027)
NCT ID: NCT02601027
Last Updated: 2021-09-23
Results Overview
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.
COMPLETED
PHASE3
120 participants
48 hours
2021-09-23
Participant Flow
Participant milestones
| Measure |
0.125% Bupivacaine
* 0.125% bupivacaine infusion through transversus abdominis plane (TAP) catheter
* Transversus Abdominis Plane (TAP) block
* Nimbus Infusion Pump IV Administration
* Bupivacaine infusion
* Acetominophen
* Hydromorphone
* Oxycodone
* Ondansetron
|
Placebo
* Saline infusion (sham) for transversus abdominis plane (TAP) catheter.
* Transversus Abdominis Plane (TAP) block
* Nimbus Infusion Pump IV Administration
* Bupivacaine infusion
* Acetominophen
* Hydromorphone
* Oxycodone
* Ondansetron
|
|---|---|---|
|
Registration to Surgery
STARTED
|
64
|
56
|
|
Registration to Surgery
COMPLETED
|
44
|
46
|
|
Registration to Surgery
NOT COMPLETED
|
20
|
10
|
|
Surgery to Assessments
STARTED
|
44
|
46
|
|
Surgery to Assessments
COMPLETED
|
44
|
46
|
|
Surgery to Assessments
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
0.125% Bupivacaine
* 0.125% bupivacaine infusion through transversus abdominis plane (TAP) catheter
* Transversus Abdominis Plane (TAP) block
* Nimbus Infusion Pump IV Administration
* Bupivacaine infusion
* Acetominophen
* Hydromorphone
* Oxycodone
* Ondansetron
|
Placebo
* Saline infusion (sham) for transversus abdominis plane (TAP) catheter.
* Transversus Abdominis Plane (TAP) block
* Nimbus Infusion Pump IV Administration
* Bupivacaine infusion
* Acetominophen
* Hydromorphone
* Oxycodone
* Ondansetron
|
|---|---|---|
|
Registration to Surgery
Withdrawal by Subject
|
20
|
10
|
Baseline Characteristics
Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA
Baseline characteristics by cohort
| Measure |
0.125% Bupivacaine
n=64 Participants
0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
Transversus Abdominis Plane (TAP) block
Nimbus Infusion Pump IV Administration
Bupivacaine infusion
Acetominophen
Hydromorphone
Oxycodone
Ondansetron
|
Placebo
n=56 Participants
Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
Transversus Abdominis Plane (TAP) block
Nimbus Infusion Pump IV Administration
Acetominophen
Hydromorphone
Oxycodone
Ondansetron
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Continuous
|
50.24 years
STANDARD_DEVIATION 9.58 • n=5 Participants
|
52.11 years
STANDARD_DEVIATION 10.50 • n=7 Participants
|
51.11 years
STANDARD_DEVIATION 9.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
56 participants
n=7 Participants
|
120 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hoursNarcotic 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.
Outcome measures
| Measure |
0.125% Bupivacaine
n=44 Participants
* 0.125% bupivacaine infusion through transversus abdominis plane (TAP) catheter
* Transversus Abdominis Plane (TAP) block
* Nimbus Infusion Pump IV Administration
* Bupivacaine infusion
* Acetominophen
* Hydromorphone
* Oxycodone
* Ondansetron
|
Placebo
n=46 Participants
* Saline infusion (sham) for transversus abdominis plane (TAP) catheter.
* Transversus Abdominis Plane (TAP) block
* Nimbus Infusion Pump IV Administration
* Bupivacaine infusion
* Acetominophen
* Hydromorphone
* Oxycodone
* Ondansetron
|
|---|---|---|
|
Post-operative Narcotic Usage
|
139.3 milligrams (mg)
Standard Deviation 117.2
|
169.2 milligrams (mg)
Standard Deviation 136.5
|
SECONDARY outcome
Timeframe: 2 daysPost-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.
Outcome measures
| Measure |
0.125% Bupivacaine
n=44 Participants
* 0.125% bupivacaine infusion through transversus abdominis plane (TAP) catheter
* Transversus Abdominis Plane (TAP) block
* Nimbus Infusion Pump IV Administration
* Bupivacaine infusion
* Acetominophen
* Hydromorphone
* Oxycodone
* Ondansetron
|
Placebo
n=46 Participants
* Saline infusion (sham) for transversus abdominis plane (TAP) catheter.
* Transversus Abdominis Plane (TAP) block
* Nimbus Infusion Pump IV Administration
* Bupivacaine infusion
* Acetominophen
* Hydromorphone
* Oxycodone
* Ondansetron
|
|---|---|---|
|
Post-operative Pain Score
|
3.76 units on a scale
Standard Deviation 1.72
|
3.96 units on a scale
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: 48 hoursOdansetron 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.
Outcome measures
| Measure |
0.125% Bupivacaine
n=44 Participants
* 0.125% bupivacaine infusion through transversus abdominis plane (TAP) catheter
* Transversus Abdominis Plane (TAP) block
* Nimbus Infusion Pump IV Administration
* Bupivacaine infusion
* Acetominophen
* Hydromorphone
* Oxycodone
* Ondansetron
|
Placebo
n=46 Participants
* Saline infusion (sham) for transversus abdominis plane (TAP) catheter.
* Transversus Abdominis Plane (TAP) block
* Nimbus Infusion Pump IV Administration
* Bupivacaine infusion
* Acetominophen
* Hydromorphone
* Oxycodone
* Ondansetron
|
|---|---|---|
|
Post-operative Anti-emetic Usage
|
5.14 milligrams (mg)
Standard Deviation 5.30
|
9.93 milligrams (mg)
Standard Deviation 13.74
|
SECONDARY outcome
Timeframe: up to 1 weekTime 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.
Outcome measures
| Measure |
0.125% Bupivacaine
n=44 Participants
* 0.125% bupivacaine infusion through transversus abdominis plane (TAP) catheter
* Transversus Abdominis Plane (TAP) block
* Nimbus Infusion Pump IV Administration
* Bupivacaine infusion
* Acetominophen
* Hydromorphone
* Oxycodone
* Ondansetron
|
Placebo
n=46 Participants
* Saline infusion (sham) for transversus abdominis plane (TAP) catheter.
* Transversus Abdominis Plane (TAP) block
* Nimbus Infusion Pump IV Administration
* Bupivacaine infusion
* Acetominophen
* Hydromorphone
* Oxycodone
* Ondansetron
|
|---|---|---|
|
Time to Ambulation
|
1.28 days
Standard Deviation 0.52
|
1.45 days
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: up to 1 weekTime 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.
Outcome measures
| Measure |
0.125% Bupivacaine
n=44 Participants
* 0.125% bupivacaine infusion through transversus abdominis plane (TAP) catheter
* Transversus Abdominis Plane (TAP) block
* Nimbus Infusion Pump IV Administration
* Bupivacaine infusion
* Acetominophen
* Hydromorphone
* Oxycodone
* Ondansetron
|
Placebo
n=46 Participants
* Saline infusion (sham) for transversus abdominis plane (TAP) catheter.
* Transversus Abdominis Plane (TAP) block
* Nimbus Infusion Pump IV Administration
* Bupivacaine infusion
* Acetominophen
* Hydromorphone
* Oxycodone
* Ondansetron
|
|---|---|---|
|
Time to First Bowel Movement
|
1.67 days
Standard Deviation 1.08
|
1.62 days
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Pre-operative Baseline and Post-operative (2-6 months)Population: Most participants were lost to follow-up, and did not return the case report form (CRF) for this patient-reported Quality of Life (QoL) data
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.
Outcome measures
| Measure |
0.125% Bupivacaine
n=10 Participants
* 0.125% bupivacaine infusion through transversus abdominis plane (TAP) catheter
* Transversus Abdominis Plane (TAP) block
* Nimbus Infusion Pump IV Administration
* Bupivacaine infusion
* Acetominophen
* Hydromorphone
* Oxycodone
* Ondansetron
|
Placebo
n=7 Participants
* Saline infusion (sham) for transversus abdominis plane (TAP) catheter.
* Transversus Abdominis Plane (TAP) block
* Nimbus Infusion Pump IV Administration
* Bupivacaine infusion
* Acetominophen
* Hydromorphone
* Oxycodone
* Ondansetron
|
|---|---|---|
|
Quality of Life Measurement
Pre-operative baseline
|
97.30 score on a scale
Standard Deviation 17.61
|
99.08 score on a scale
Standard Deviation 20.73
|
|
Quality of Life Measurement
Post-operative (2 to 6 month)
|
342.11 score on a scale
Standard Deviation 26.42
|
358.00 score on a scale
Standard Deviation 16.83
|
Adverse Events
0.125% Bupivacaine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.125% Bupivacaine
n=64 participants at risk
* 0.125% bupivacaine infusion through transversus abdominis plane (TAP) catheter
* Transversus Abdominis Plane (TAP) block
* Nimbus Infusion Pump IV Administration
* Bupivacaine infusion
* Acetominophen
* Hydromorphone
* Oxycodone
* Ondansetron
|
Placebo
n=56 participants at risk
* Saline infusion (sham) for transversus abdominis plane (TAP) catheter.
* Transversus Abdominis Plane (TAP) block
* Nimbus Infusion Pump IV Administration
* Bupivacaine infusion
* Acetominophen
* Hydromorphone
* Oxycodone
* Ondansetron
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.6%
1/64 • Number of events 1 • Through 7 days post-operative
|
7.1%
4/56 • Number of events 4 • Through 7 days post-operative
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/64 • Through 7 days post-operative
|
1.8%
1/56 • Number of events 1 • Through 7 days post-operative
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
1.6%
1/64 • Number of events 1 • Through 7 days post-operative
|
1.8%
1/56 • Number of events 1 • Through 7 days post-operative
|
|
Injury, poisoning and procedural complications
Bruising
|
1.6%
1/64 • Number of events 1 • Through 7 days post-operative
|
1.8%
1/56 • Number of events 1 • Through 7 days post-operative
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Chest wall necrosis, specify
|
1.6%
1/64 • Number of events 1 • Through 7 days post-operative
|
0.00%
0/56 • Through 7 days post-operative
|
|
General disorders
Edema Limbs
|
0.00%
0/64 • Through 7 days post-operative
|
1.8%
1/56 • Number of events 1 • Through 7 days post-operative
|
|
General disorders
Fever
|
0.00%
0/64 • Through 7 days post-operative
|
3.6%
2/56 • Number of events 2 • Through 7 days post-operative
|
|
General disorders
Localized Edema
|
1.6%
1/64 • Number of events 1 • Through 7 days post-operative
|
0.00%
0/56 • Through 7 days post-operative
|
|
Nervous system disorders
Headache
|
1.6%
1/64 • Number of events 1 • Through 7 days post-operative
|
0.00%
0/56 • Through 7 days post-operative
|
|
Vascular disorders
Hematoma
|
7.8%
5/64 • Number of events 5 • Through 7 days post-operative
|
7.1%
4/56 • Number of events 4 • Through 7 days post-operative
|
|
Vascular disorders
Hypotension
|
1.6%
1/64 • Number of events 1 • Through 7 days post-operative
|
3.6%
2/56 • Number of events 2 • Through 7 days post-operative
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
1.6%
1/64 • Number of events 1 • Through 7 days post-operative
|
0.00%
0/56 • Through 7 days post-operative
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/64 • Number of events 1 • Through 7 days post-operative
|
1.8%
1/56 • Number of events 1 • Through 7 days post-operative
|
|
Infections and infestations
Otitis media
|
1.6%
1/64 • Number of events 1 • Through 7 days post-operative
|
0.00%
0/56 • Through 7 days post-operative
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/64 • Through 7 days post-operative
|
1.8%
1/56 • Number of events 1 • Through 7 days post-operative
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.6%
1/64 • Number of events 1 • Through 7 days post-operative
|
1.8%
1/56 • Number of events 1 • Through 7 days post-operative
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/64 • Through 7 days post-operative
|
1.8%
1/56 • Number of events 1 • Through 7 days post-operative
|
|
Infections and infestations
Shingles
|
1.6%
1/64 • Number of events 1 • Through 7 days post-operative
|
0.00%
0/56 • Through 7 days post-operative
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/64 • Through 7 days post-operative
|
1.8%
1/56 • Number of events 1 • Through 7 days post-operative
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
1.6%
1/64 • Number of events 1 • Through 7 days post-operative
|
1.8%
1/56 • Number of events 1 • Through 7 days post-operative
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/64 • Through 7 days post-operative
|
1.8%
1/56 • Number of events 1 • Through 7 days post-operative
|
|
Vascular disorders
Thromboembolic event
|
1.6%
1/64 • Number of events 1 • Through 7 days post-operative
|
0.00%
0/56 • Through 7 days post-operative
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/64 • Through 7 days post-operative
|
1.8%
1/56 • Number of events 1 • Through 7 days post-operative
|
|
Investigations
Urine output decreased
|
0.00%
0/64 • Through 7 days post-operative
|
1.8%
1/56 • Number of events 1 • Through 7 days post-operative
|
|
Infections and infestations
Urinary Tract Infection
|
1.6%
1/64 • Number of events 1 • Through 7 days post-operative
|
0.00%
0/56 • Through 7 days post-operative
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/64 • Through 7 days post-operative
|
1.8%
1/56 • Number of events 1 • Through 7 days post-operative
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/64 • Through 7 days post-operative
|
1.8%
1/56 • Number of events 1 • Through 7 days post-operative
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.6%
1/64 • Number of events 1 • Through 7 days post-operative
|
0.00%
0/56 • Through 7 days post-operative
|
Additional Information
Gordon Kwanlyp Lee, Professor of Surgery (Plastic and Reconstructive Surgery)
Stanford University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place