Phase 4
Completed N=60
Comparing Local Anesthetics for TAP Block During Abdominally-based Free Flap for Breast Reconstruction
Breast Reconstruction · Anesthesia · Transverse Abdominis Plane Block
Source: ClinicalTrials.gov NCT03700970 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcomePrimary: Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME) — 19.8; 23.6; 20.7; 25.2 mg morphine equivalents
◆ Published Evidence
Emerging
17citations · ~9 / year
Randomized Controlled Trial Comparing Liposomal to Plain Bupivacaine in the Transversus Abdominis Plane for DIEP Flap Breast Reconstruction.
Summary
This study will compare the efficiency of transversus abominus plane (TAP) block using liposomal bupivacaine versus plain bupivacaine that is administered in the operating room under ultrasound guidance prior to the in patients undergoing abdominally-based free flap breast reconstruction at Vanderbilt University Medical Center.
Linked Publications
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Randomized Controlled Trial Comparing Liposomal to Plain Bupivacaine in the Transversus Abdominis Plane for DIEP Flap Breast Reconstruction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME) |
19.8; 23.6; 20.7; 25.2; 12.2; 12.8 | — |
| SECONDARY Pain Measure |
2.43; 2.93; 2; 3.1; 2.9; 3.1 | — |
| SECONDARY Time to First Opiate Use |
12.4; 8.2 | — |
| SECONDARY Time to Return of Bowel Function |
2.62; 2.58 | — |
| SECONDARY Length of Stay |
2.43; 2.23 | — |
| SECONDARY Ambulation |
1; 1 | — |
| SECONDARY Non-narcotic Pain Medication Intake: Acetaminophen |
2630; 2840; 2937; 2868; 2160; 1945 | — |
| SECONDARY Non Narcotic Pain Medication Intake: Cyclobenzaprine |
0.5; 1.2; 2; 1.2; 2.5; 1.5 | — |
| SECONDARY Non Narcotic Pain Medication Intake: Gabapentin |
730; 750; 807; 813; 680; 577 | — |
| SECONDARY Non Narcotic Pain Medication Intake: Celebrex |
200; 187; 193; 203; 67; 60 | — |
| SECONDARY Non Narcotic Pain Medication Intake: Ondansetron |
1.3; 2.3; 0.4; 0.4; 0.27; 0.27 | — |
Eligibility Criteria
Inclusion Criteria
- age between 18-85 years
- males or females
- plastic surgery for abdominally-based free flap breast reconstruction.
Exclusion Criteria
- those not candidates for TAP blocks due to allergies to the medications (e.g., bupivacaine)
- those with anatomic contra-indications to performing a TAP block
- those unwilling to participate in follow-up assessments
- vulnerable populations
- chronic pain or associated diagnosis
Data sourced from ClinicalTrials.gov (NCT03700970) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.