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NCT05972018 · ClinicalTrials.gov registry record · Phase 4
Liposomal Bupivacaine/Bupivacaine in Rectus Sheath Blocks Versus Ropivacaine in Rectus Sheath Blocks And Catheters
A Phase 4 study of Aortic Aneurysm, Abdominal and Aortic Diseases, sponsored by Hartford Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT05972018: Recruiting Phase 4 study of Aortic Aneurysm, Abdominal and Aortic Diseases, sponsored by Hartford Hospital.
NCT05972018 is a Phase 4 study of Aortic Aneurysm, Abdominal and Aortic Diseases that is actively recruiting participants, run by Hartford Hospital. The registered enrollment target is 14 participants, below the 153-participant average among 8 other Aortic Aneurysm, Abdominal trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05972018, a Phase 4 study of Aortic Aneurysm, Abdominal and Aortic Diseases, is actively recruiting participants, sponsored by Hartford Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this pilot study is to compare single shot rectus sheath blocks of liposomal bupivacaine/bupivacaine mixture to bilateral rectus sheath catheters infused with ropivacaine (standard of care at our facility) in patients undergoing vascular surgery with an open mid-abdominal laparotomy incision. This study will assess the safety and feasibility of this approach compared to standard of care. Participants will receive either a single dose of liposomal bupivacaine/bupivacaine mixture intraoperatively at the end of surgery through bilateral rectus sheath blocks (LB/B group) or the standard of care ropivacaine intraoperatively at the end of surgery through bilateral rectus sheath blocks with the insertion of bilateral RS catheter for continuous ropivacaine infusion plus repeated daily boluses (Catheter group; standard care). They will be assessed for differences in the rate of postoperative complications, resources consumed with each intervention, as well as postoperative pain scores, opioid consumption, hospital and PACU length of stay, patient's satisfaction, and quality of recovery, and hospital length of stay.
Primary Outcome
To compare the resources consumed by each intervention from many different perspectives (e.g. anesthesia staff cost per time spent to perform the study intervention and the successive daily evaluations, facility cost per length of stay, block and catheter medication cost, block and catheter supply cost.)
Conditions Studied
Interventions
- DRUG Bupivacain
- DRUG Liposomal bupivacaine
- DRUG Ropivacaine
Study Locations (1)
Connecticut
- Hartford Hospital - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2023-10-18 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 4 |
What NCT05972018 shows while recruiting
NCT05972018 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 153-participant average among 8 other Aortic Aneurysm, Abdominal trials with a reported enrollment target (91% lower).
The record links to 4 conditions, with Aortic Aneurysm, Abdominal appearing as the primary indexed condition, and to 3 interventions - of which Bupivacain is the first listed.
NCT05972018 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT05972018 about?
NCT05972018 is a clinical study titled "Liposomal Bupivacaine/Bupivacaine in Rectus Sheath Blocks Versus Ropivacaine in Rectus Sheath Blocks And Catheters". The goal of this pilot study is to compare single shot rectus sheath blocks of liposomal bupivacaine/bupivacaine mixture to bilateral rectus sheath catheters infused with ropivacaine (standard of care at our facility) in patients undergoing vascular surgery with an open mid-abdominal laparotomy inci...
What is the current status of trial NCT05972018?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2023-10-18. Estimated completion is 2026-12-30.
What conditions does trial NCT05972018 study?
This clinical trial studies the following conditions: Aortic Aneurysm, Abdominal, Aortic Diseases, Aortoiliac Occlusive Disease, Abdominal Aortic Occlusion.
What interventions are being tested in trial NCT05972018?
The interventions under investigation include: Bupivacain (DRUG), Liposomal bupivacaine (DRUG), Ropivacaine (DRUG).
Who is sponsoring clinical trial NCT05972018?
This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05972018 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05972018's enrollment target sits among peer trials
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