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Transversus Abdominis Plane (TAP) block is a useful tool in pain management after abdominal surgery. It is a regional nerve block that targets T6-L1 thoracolumbar nerves running in the plane between internal oblique and transversus abdominis muscle. It is shown to help with post-operative pain management, reducing pain scores and narcotic pain medication use, as well as promoting earlier return to activity and recovery. TAP block became a very popular, safe, and effective therapeutic adjunct for many different abdominal surgeries ranging from obstetric procedures to general surgery procedures like colorectal surgery. Furthermore, it is used in plastic surgery procedures such as Deep Inferior Epigastric Perforator (DIEP) free flap or Transverse Rectus Abdominis Myocutaneous (TRAM) flap, as they involve extensive amount of abdominal soft tissue incision. Previous studies have shown that TAP block in these procedures significantly reduce post-op pain and narcotic pain medication use. More recently, Exparel (liposomal bupivacaine) has risen to spotlight for providing a longer, sustained local anesthesia. Various surgical disciplines have adopted this agent as part of their pain management protocol. However, there are no literatures that describe the effect of TAP block using Exparel for breast free flap population. The study hypothesize that delivering TAP block with Exparel (vs. plain bupivacaine) will provide longer regional blocking effect, hence aiding in pain control and recovery postoperatively. The investigators will be analyzing postop narcotic pain medication requirement and pain scores to look into this question.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control - plain bupivacaine | Active Comparator | Receives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively |
|
| Experimental - Liposomal bupivacaine | Experimental | Receives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine TAP block | Drug | Group will receive Liposomal bupivacaine TAP block (mixed with plain bupivacaine) intraoperatively during free flap breast reconstruction as part of the multimodal pain control. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-op Pain Scores During Initial Hospitalization | Visual analog pain scale. Scores range from 0 to 10, 0 being no pain and 10 being worse pain that one experienced in their lifetime. | During initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first |
| Post-op Narcotic Pain Medication Use During Hospitalization | total amount of morphine milliequivalent | during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | hospital length of stay | during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with ages <18 years
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| Name | Affiliation | Role |
|---|---|---|
| John Stranix, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Medical Center | Charlottesville | Virginia | 22902 | United States | ||
| University of Virginia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38315156 | Derived | Park RH, Chou J, DeVito RG, Elmer A, Hollenbeck ST, Campbell CA, Stranix JT. Effectiveness of Liposomal Bupivacaine Transversus Abdominis Plane Block in DIEP Flap Breast Reconstruction: A Randomized Controlled Trial. Plast Reconstr Surg. 2024 Oct 1;154(4S):52S-59S. doi: 10.1097/PRS.0000000000011326. Epub 2024 Sep 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control - Plain Bupivacaine | Receives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively Bupivacain: Group will receive plain bupivacaine TAP block intraoperatively during free flap breast reconstruction as part of the multimodal pain control. |
| FG001 | Experimental - Liposomal Bupivacaine | Receives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively Liposomal bupivacaine TAP block: Group will receive Liposomal bupivacaine TAP block (mixed with plain bupivacaine) intraoperatively during free flap breast reconstruction as part of the multimodal pain control. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control - Plain Bupivacaine | Receives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively Bupivacain: Group will receive plain bupivacaine TAP block intraoperatively during free flap breast reconstruction as part of the multimodal pain control. |
| BG001 | Experimental - Liposomal Bupivacaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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-op Pain Scores During Initial Hospitalization | Visual analog pain scale. Scores range from 0 to 10, 0 being no pain and 10 being worse pain that one experienced in their lifetime. | Posted | Median | Inter-Quartile Range | score on a scale | During initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first |
|
21 months
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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 | Control - Plain Bupivacaine | Receives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively Bupivacain: Group will receive plain bupivacaine TAP block intraoperatively during free flap breast reconstruction as part of the multimodal pain control. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John T Stranix, MD | University of Virginia | 434-924-5078 | jts3v@uvahealth.org |
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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 | Feb 27, 2021 | May 15, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Control group: TAP block with plain bupivacaine Intervention group: TAP block with plain bupivacaine + liposomal bupivacaine
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| Bupivacain | Drug | Group will receive plain bupivacaine TAP block intraoperatively during free flap breast reconstruction as part of the multimodal pain control. |
|
| Charlottesville |
| Virginia |
| 22903 |
| United States |
Receives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively Liposomal bupivacaine TAP block: Group will receive Liposomal bupivacaine TAP block (mixed with plain bupivacaine) intraoperatively during free flap breast reconstruction as part of the multimodal pain control. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Receives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively
Liposomal bupivacaine TAP block: Group will receive Liposomal bupivacaine TAP block (mixed with plain bupivacaine) intraoperatively during free flap breast reconstruction as part of the multimodal pain control.
|
|
| Primary | Post-op Narcotic Pain Medication Use During Hospitalization | total amount of morphine milliequivalent | Posted | Median | Inter-Quartile Range | MME | during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first |
|
|
|
| Secondary | Length of Hospital Stay | hospital length of stay | Posted | Mean | Standard Deviation | Days | during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first |
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | Experimental - Liposomal Bupivacaine | Receives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively Liposomal bupivacaine TAP block: Group will receive Liposomal bupivacaine TAP block (mixed with plain bupivacaine) intraoperatively during free flap breast reconstruction as part of the multimodal pain control. | 0 | 58 | 0 | 58 | 0 | 58 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |