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: Clinical Trial Phase 4 study, sponsored by Loma Linda University.
NCT04360421 is a Phase 4 study that was terminated before completion, run by Loma Linda University. The registered enrollment target is 7 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Total morphine equivalent
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 |
Why NCT04360421 stopped before completion
NCT04360421 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Liposomal bupivacaine is the first listed.
NCT04360421 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT04360421's enrollment target sits among peer trials
7 1981st of 2000 higher than 18 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI