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Local Anesthetic
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
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 moreAwards & 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
Find a Location
Who is running the clinical trial?
Ryan Mountjoy, MDLead Sponsor
MaineHealthOTHER
74 Previous Clinical Trials
43,745 Total Patients Enrolled
1 Trials studying Infections
175 Patients Enrolled for Infections
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with a substance use disorder.You are allergic to local anesthetics.You have an infection where the needle will be inserted.You have a body mass index (BMI) greater than 40, which means you are severely obese.You have a history of blood clotting problems.Recent amputation due to a medical emergency.You are taking more than 90 milligrams of morphine (or equivalent) per day.You have a certain level of physical health, as classified by the American Society of Anesthesiologists.You are planning to have a surgery to remove a limb or revise the remaining part of a limb.You have had an amputation on the opposite side of your body.
Research Study Groups:
This trial has the following groups:- Group 1: Continuous perineural popliteal nerve block catheter
- Group 2: Single Shot Perineural Popliteal Nerve Block
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.