← Back to Search

Local Anesthetic

Liposomal bupivacaine for Local Anesthesia

Phase 4
Waitlist Available
Led By Kristyn Mannoia, MD
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who meet clinical indication for unilateral or bilateral lower extremity major amputation, either primary or revision: partial foot, ankle disarticulation, transtibial, knee disarticulation, transfemoral
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks
Awards & highlights

Study Summary

This trial is testing whether using liposomal bupivacaine, an anesthetic, during a major extremity amputation can decrease pain and the use of opioids afterwards, as well as the length of the hospital stay.

Eligible Conditions
  • Local Anesthesia
  • Amputation
  • Opioid Use Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have had a major amputation of one or both legs, including amputations through the ankle, knee or thigh.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total cost of stay
Total opioid use
Secondary outcome measures
Pain scores

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intraoperative liposomal bupivacaine field blockExperimental Treatment1 Intervention
Patients will receive the maximum dosage of liposomal bupivacaine allowed for their body weight or the full vial, whichever is less. Injected once, along the incision before closure of the skin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liposomal bupivacaine
2016
Completed Phase 4
~1970

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
304 Previous Clinical Trials
259,481 Total Patients Enrolled
Kristyn Mannoia, MDPrincipal InvestigatorLoma Linda University Department of Vascular Surgery

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted its sanction to Liposomal bupivacaine?

"Liposomal bupivacaine has gone through the necessary levels of assessment to receive approval, so it was scored 3 for safety."

Answered by AI

Have any prior studies been conducted involving Liposomal bupivacaine?

"At present, there are 109 ongoing clinical trials exploring the uses of Liposomal bupivacaine. Of these studies, 18 have reached Phase 3 and most are located in Philadelphia, Pennsylvania; however, 144 sites worldwide are conducting research on this drug therapy."

Answered by AI

Are there still vacancies left in the clinical trial?

"The details of this clinical trial, initially posted 4/21/2020 and recently amended 5/26/2022, are currently being advertised with the goal of recruiting participants."

Answered by AI

What symptoms does Liposomal bupivacaine usually address?

"Liposomal bupivacaine is the most commonly used treatment for pemphigus and has also been known to address acute nonspecific tenosynovitis, general anesthesia, and lupus erythematosus cell."

Answered by AI

What is the cap on patient participation in this trial?

"Affirmative. Clinicaltrials.gov attests that this medical experiment, which was originally posted on April 21st 2020, is actively looking for participants. The research team needs to find 50 individuals from one specific site to complete the study."

Answered by AI
Recent research and studies
~1 spots leftby Mar 2025