Liposomal Bupivacaine vs Nerve Catheters for Post-Amputation Pain

Phase 4

Recruiting

Research Sponsored by Ryan Mountjoy, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours post-operatively

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will investigate whether perineural catheters and liposomal bupivacaine are effective at managing post-limb amputation pain. The data collected will be used to inform the design of a larger study.

Who is the study for?

This trial is for individuals scheduled for primary below-knee amputation or stump revision, who can understand and consent in English. They should not have a severe allergy to local anesthetics, infections where the needle will go, extreme obesity (BMI > 40), bleeding disorders, be on high-dose opioids (>90 MME/day), have substance use disorders, or need emergency amputations.

What is being tested?

The study compares two pain management methods after leg amputations: Liposomal bupivacaine versus continuous nerve catheters with Bupivacaine Hydrochloride. It's designed to gather initial data at Maine Medical Center to plan a larger future study.

What are the potential side effects?

Possible side effects include reactions at the injection site like pain or swelling, nausea, vomiting, constipation from bupivacaine; liposomal form may prolong these effects due to its extended release.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours post-operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain assessed by Numerical Rating Scale (NRS)

Secondary study objectives

Opioid Consumption

Amputation

Post-operative Length of Stay

+1 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: Continuous perineural popliteal nerve block catheterActive Control1 Intervention

Placement of continuous perineural popliteal nerve block catheter with injection of 30cc 0.5% bupivacaine within one hour prior to surgery, followed by continuous infusion of 10cc 0.3% ropivacaine (current standard practice) for at least 72 hours following surgery. Saphenous single shot 20cc 0.2

Group II: Single Shot Perineural Popliteal Nerve BlockActive Control1 Intervention

Single shot perineural popliteal nerve block injection of 10cc 13.3% liposomal bupivacaine combined with 15cc 0.50% bupivacaine hydrochloride within one hour prior to surgery

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