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| ID | Type | Description | Link |
|---|---|---|---|
| BRS0058 | Other Identifier | OnCore |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.125% Bupivacaine | Experimental | 0.125% bupivacaine infusion via transversus abdominis plane (TAP) catheter |
|
| Placebo | Placebo Comparator | Saline infusion (sham) via transversus abdominis plane (TAP) catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transversus Abdominis Plane (TAP) block | Procedure |
| ||
| Nimbus Infusion Pump IV Administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria
Exclusion Criteria
Female
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| Name | Affiliation | Role |
|---|---|---|
| Gordon K Lee, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28445351 | Background | Mundy LR, Homa K, Klassen AF, Pusic AL, Kerrigan CL. Breast Cancer and Reconstruction: Normative Data for Interpreting the BREAST-Q. Plast Reconstr Surg. 2017 May;139(5):1046e-1055e. doi: 10.1097/PRS.0000000000003241. | |
| 19644246 | Background | Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.125% Bupivacaine |
|
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Registration to Surgery |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 28, 2018 |
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| Device |
|
| Bupivacaine infusion | Drug |
|
|
| Acetominophen | Drug |
|
|
| Hydromorphone | Drug |
|
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| Oxycodone | Drug |
|
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| Ondansetron | Drug |
|
|
| 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. | 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. | 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. | 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. | Pre-operative Baseline and Post-operative (2-6 months) |
| 31577663 | Background | Voineskos SH, Klassen AF, Cano SJ, Pusic AL, Gibbons CJ. Giving Meaning to Differences in BREAST-Q Scores: Minimal Important Difference for Breast Reconstruction Patients. Plast Reconstr Surg. 2020 Jan;145(1):11e-20e. doi: 10.1097/PRS.0000000000006317. |
| Result | Kwong JW, Tijerina JD, Choi S, Shakir A, Nguyen DH, Nazerali RS, Lee GK. Randomized Double-Blinded, Placebo-Controlled Trial: Transversus Abdominis Plane (TAP) Blocks in Breast Cancer Patients Undergoing Reconstruction with Abdominal Free Flap. Annual Meeting of the California Society of Plastic Surgeons. San Diego, California. May 19, 2018. |
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| COMPLETED |
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| NOT COMPLETED |
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| Surgery to Assessments |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.125% Bupivacaine | 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 |
| BG001 | Placebo | Saline infusion (sham) via transversus abdominis plane (TAP) catheter. Transversus Abdominis Plane (TAP) block Nimbus Infusion Pump IV Administration Acetominophen Hydromorphone Oxycodone Ondansetron |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | milligrams (mg) | 48 hours |
|
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 2 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | milligrams (mg) | 48 hours |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | days | up to 1 week |
| |||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | days | up to 1 week |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | 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 | Posted | Mean | Standard Deviation | score on a scale | Pre-operative Baseline and Post-operative (2-6 months) |
|
Through 7 days post-operative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.125% Bupivacaine |
| 0 | 64 | 0 | 64 | 21 | 64 |
| EG001 | Placebo |
| 0 | 56 | 0 | 56 | 27 | 56 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bullous dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Chest wall necrosis, specify | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema Limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Localized Edema | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle cramp | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Shingles | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Urine output decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Vasovagal reaction | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gordon Kwanlyp Lee, Professor of Surgery (Plastic and Reconstructive Surgery) | Stanford University | 650-723-5824 | glee@stanford.edu |
| Jun 18, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003766 | Dental Occlusion |
| D002045 | Bupivacaine |
| D000082 | Acetaminophen |
| D004091 | Hydromorphone |
| D010098 | Oxycodone |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000083 | Acetanilides |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003061 | Codeine |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
Not provided
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| >=65 years |
|
| Male |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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| Units |
|---|
| Counts |
|---|
| Participants |
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