A Phase 3 interventional study of Transversus Abdominis Plane (TAP) block and Nimbus Infusion Pump IV Administration in Breast - Female, sponsored by Stanford University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-23.
Sponsored by Stanford University · Phase 3, Interventional, and Supportive care
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.
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:
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Exclusion Criteria
0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter
Procedure: Transversus Abdominis Plane (TAP) block · Device: Nimbus Infusion Pump IV Administration · Drug: Bupivacaine infusion · Drug: Acetominophen · Drug: Hydromorphone · Drug: Oxycodone · Drug: Ondansetron
Saline infusion (sham) via transversus abdominis plane (TAP) catheter.
Procedure: Transversus Abdominis Plane (TAP) block · Device: Nimbus Infusion Pump IV Administration · Drug: Acetominophen · Drug: Hydromorphone · Drug: Oxycodone · Drug: Ondansetron
Also known as: Exparel, Marcaine, Marcaine Spinal, Sensorcaine, Sensorcaine-MPF, Sensorcaine-MPF Spinal, ReadySharp bupivacaine, P-Care M
Also known as: Tylenol
Also known as: Dilaudid, Dilaudid-HP, Exalgo
Also known as: Oxycontin, Xtampza ER, Oxaydo, Roxicodone
Also known as: Zofran, Zofran ODT, Zuplenz
Post-operative Narcotic Usage
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.
Time frame: 48 hours
Post-operative Pain Score
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.
Time frame: 2 days
Post-operative Anti-emetic Usage
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.
Time frame: 48 hours
Time to Ambulation
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.
Time frame: up to 1 week
Time to First Bowel Movement
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.
Time frame: up to 1 week
Quality of Life Measurement
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 frame: Pre-operative Baseline and Post-operative (2-6 months)
| Milestone | 0.125% Bupivacaine | Placebo |
|---|---|---|
| Started | 64 | 56 |
| Completed | 44 | 46 |
| Not completed | 20 | 10 |
| Withdrew: Withdrawal by subject | 20 | 10 |
| Milestone | 0.125% Bupivacaine | Placebo |
|---|---|---|
| Started | 44 | 46 |
| Completed | 44 | 46 |
| Not completed | 0 | 0 |
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.
| milligrams (mg) | 0.125% Bupivacaine | Placebo |
|---|---|---|
| Post-operative Narcotic Usage | 139.3 ± 117.2 | 169.2 ± 136.5 |
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.
| units on a scale | 0.125% Bupivacaine | Placebo |
|---|---|---|
| Post-operative Pain Score | 3.76 ± 1.72 | 3.96 ± 2.14 |
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.
| milligrams (mg) | 0.125% Bupivacaine | Placebo |
|---|---|---|
| Post-operative Anti-emetic Usage | 5.14 ± 5.30 | 9.93 ± 13.74 |
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.
| days | 0.125% Bupivacaine | Placebo |
|---|---|---|
| Time to Ambulation | 1.28 ± 0.52 | 1.45 ± 0.62 |
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.
| days | 0.125% Bupivacaine | Placebo |
|---|---|---|
| Time to First Bowel Movement | 1.67 ± 1.08 | 1.62 ± 0.99 |
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.
| score on a scale | 0.125% Bupivacaine | Placebo |
|---|---|---|
| Pre-operative baseline | 97.30 ± 17.61 | 99.08 ± 20.73 |
| Post-operative (2 to 6 month) | 342.11 ± 26.42 | 358.00 ± 16.83 |
Collected over Through 7 days post-operative. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 0.125% Bupivacaine | 0/64 (0%) | 0/64 (0%) | 21/64 (32.8%) |
| Placebo | 0/56 (0%) | 0/56 (0%) | 27/56 (48.2%) |
| Event | 0.125% Bupivacaine | Placebo |
|---|---|---|
| HematomaVascular disorders | 5/64 | 4/56 |
| AnemiaBlood and lymphatic system disorders | 1/64 | 4/56 |
| FeverGeneral disorders | 0/64 | 2/56 |
| HypotensionVascular disorders | 1/64 | 2/56 |
| AnxietyPsychiatric disorders | 0/64 | 1/56 |
| Bullous dermatitisSkin and subcutaneous tissue disorders | 1/64 | 1/56 |
| BruisingInjury, poisoning and procedural complications | 1/64 | 1/56 |
| Edema LimbsGeneral disorders | 0/64 | 1/56 |
| NauseaGastrointestinal disorders | 1/64 | 1/56 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 0/64 | 1/56 |
| Age, Categorical(Participants) | 0.125% Bupivacaine | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 58 | 49 | 107 |
| >=65 years | 6 | 7 | 13 |
| Age, Continuous(years) | 0.125% Bupivacaine | Placebo | Total |
|---|---|---|---|
| Mean | 50.24 ± 9.58 | 52.11 ± 10.50 | 51.11 ± 9.98 |
| Sex: Female, Male(Participants) | 0.125% Bupivacaine | Placebo | Total |
|---|---|---|---|
| Female | 64 | 56 | 120 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 0.125% Bupivacaine | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 8 | 8 | 16 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 3 | 2 | 5 |
| White | 44 | 38 | 82 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 8 | 7 | 15 |
| Region of Enrollment(participants) | 0.125% Bupivacaine | Placebo | Total |
|---|---|---|---|
| United States | 64 | 56 | 120 |
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