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NCT04777591 · ClinicalTrials.gov registry record · Phase 4
Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction
A Phase 4 study, sponsored by University of Virginia.
- Completed
- Registry status
- Phase 4
- Development phase
- 117
- Enrollment target
NCT04777591 is a Phase 4 study that has completed, run by University of Virginia. The registered enrollment target is 117 participants.
The verdict
NCT04777591, a Phase 4 study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 117 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Bupivacain
- DRUG Liposomal bupivacaine TAP block
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2022-12-28 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04777591
The ClinicalTrials.gov registry entry for NCT04777591 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bupivacain is the first listed.
NCT04777591 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04777591 about?
NCT04777591 is a clinical study titled "Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction". 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 manag...
What is the current status of trial NCT04777591?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 117 participants. The study started on 2021-03-01. Estimated completion is 2022-12-28.
What interventions are being tested in trial NCT04777591?
The interventions under investigation include: Bupivacain (DRUG), Liposomal bupivacaine TAP block (DRUG).
Who is sponsoring clinical trial NCT04777591?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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