Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04360421 · ClinicalTrials.gov registry record · Phase 4
Use of Long-acting Bupivacaine In Lower Extremity Amputation
A Phase 4 study, sponsored by Loma Linda University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 7
- Enrollment target
NCT04360421 is a Phase 4 study that was terminated before completion, run by Loma Linda University. The registered enrollment target is 7 participants.
The verdict
NCT04360421, a Phase 4 study, was terminated before completion, sponsored by Loma Linda University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 7 participants
- Enrollment target
Study Summary
The purpose of this investigator-initiated study is to assess the use of liposomal bupivacaine in major extremity amputation and its effects on post-operative opioid narcotic use, length of stay, and in-hospital costs. Liposomal bupivacaine is an encapsulated, injectable amide anesthetic intended for use in long-acting local anesthesia. It has been shown in randomized trials to be effective in reducing post-operative pain while reducing opioid narcotic use and length of hospital stay following several surgical procedures, particularly after total knee arthroplasty. Extremity amputation is a painful operation often performed in seriously ill or debilitated patients, often related to infection, trauma or malignancy. Application of liposomal bupivacaine in extremity amputation is not well described. The investigators intend to enroll adults greater than age 18 years of age who are to undergo major extremity amputation. Patients will receive targeted injections of liposomal bupivacaine during their procedure. Patient pain scores, total opioid use, and length of hospital stay will be tracked. Patients receiving liposomal bupivicaine will be compared to similarly matched subjects who received standard anesthesia regimens without liposomal bupivicaine. The investigators hypothesize that liposomal bupivicaine used during major amputation decreases opioid use, hospital stay, and in-hospital costs.
Interventions
- DRUG Liposomal bupivacaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2020-04-21 |
| Est. Completion | 2023-08-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04360421
The ClinicalTrials.gov registry entry for NCT04360421 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Loma Linda University, which has 237 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Liposomal bupivacaine is the first listed.
NCT04360421 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04360421 about?
NCT04360421 is a clinical study titled "Use of Long-acting Bupivacaine In Lower Extremity Amputation". The purpose of this investigator-initiated study is to assess the use of liposomal bupivacaine in major extremity amputation and its effects on post-operative opioid narcotic use, length of stay, and in-hospital costs. Liposomal bupivacaine is an encapsulated, injectable amide anesthetic intended fo...
What is the current status of trial NCT04360421?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 7 participants. The study started on 2020-04-21. Estimated completion is 2023-08-01.
What interventions are being tested in trial NCT04360421?
The interventions under investigation include: Liposomal bupivacaine (DRUG).
Who is sponsoring clinical trial NCT04360421?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.