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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 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.

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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.

Conditions Studied

Aortic Aneurysm, Abdominal Aortic Diseases Aortoiliac Occlusive Disease Abdominal Aortic Occlusion

Interventions

  • DRUG Bupivacain
  • DRUG Liposomal bupivacaine
  • DRUG Ropivacaine

Study Locations (1)

Connecticut

  • Hartford Hospital - Hartford

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2023-10-18
Est. Completion 2026-12-30
Phase Phase 4

Sponsor

Hartford Hospital

75 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05972018

The ClinicalTrials.gov registry entry for NCT05972018 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 153-participant average among 8 other Aortic Aneurysm, Abdominal trials with a reported enrollment target (91% lower). The listed sponsor is Hartford Hospital, which has 75 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.