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NCT04345341 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Laparoscopic-assisted Transversus Abdominus Plane (TAP) Block Compared to Ultrasound-guided TAP Block in Minimally Invasive Gynecologic Surgeries: A Prospective, Randomized Control Trial.
A Phase 2 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT04345341 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 80 participants.
The verdict
NCT04345341, a Phase 2 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
We propose a clinical trial to determine the efficacy of Laparoscopic Transversus Abdominis Plane (LA-TAP) performed intraoperatively compared with usual postoperative analgesia without LA-TAP block. We hypothesise that there will be a decrease in postoperative opioid utilization and in pain scores for patients randomized to receive the LA-TAP block verses those who do not. We expect that patients will opt to take less break through opioid medication in the LA-TAP block group versus the no TAP block group. Investigators aim to answer the above questions through the following primary and secondary outcomes: Primary outcomes Is there a difference in pain scores reported by the patient at 24 hours following LA-TAP versus no TAP block? Is there a clinically significant difference in cumulative postoperative opioid consumption, expressed as milligram morphine equivalents (MMEs) at 24 hours following LA-TAP blocks versus no TAP block? Secondary outcomes Is there a difference between study groups in pain scores at 48 \& 72 hours? Is there a difference between study groups in total opioid consumption (MMEs) by 48 \& 72 hours? Is there a difference between the study groups for reported post-operative nausea and vomiting? Is there a difference between the study groups in operating time? Is there a difference between the study groups in the length of Hospital stay? Is there a difference between the study groups in patient's satisfaction?
Interventions
- DRUG TAP block with liposomal bupivacaine and bupivacaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2020-11-01 |
| Est. Completion | 2023-10-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04345341
The ClinicalTrials.gov registry entry for NCT04345341 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TAP block with liposomal bupivacaine and bupivacaine is the first listed.
NCT04345341 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04345341 about?
NCT04345341 is a clinical study titled "Efficacy of Laparoscopic-assisted Transversus Abdominus Plane (TAP) Block Compared to Ultrasound-guided TAP Block in Minimally Invasive Gynecologic Surgeries: A Prospective, Randomized Control Trial.". We propose a clinical trial to determine the efficacy of Laparoscopic Transversus Abdominis Plane (LA-TAP) performed intraoperatively compared with usual postoperative analgesia without LA-TAP block. We hypothesise that there will be a decrease in postoperative opioid utilization and in pain scores ...
What is the current status of trial NCT04345341?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2020-11-01. Estimated completion is 2023-10-15.
What interventions are being tested in trial NCT04345341?
The interventions under investigation include: TAP block with liposomal bupivacaine and bupivacaine (DRUG).
Who is sponsoring clinical trial NCT04345341?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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