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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain assessed by Numerical Rating Scale (NRS)

Secondary outcome measures

Opioid Consumption

Amputation

Post-operative Length of Stay

+1 more

Trial Design

2Treatment groups

Active Control

Group I: 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

Group II: 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ryan Mountjoy, MDLead Sponsor

MaineHealthOTHER

71 Previous Clinical Trials

49,277 Total Patients Enrolled

Media Library

Liposomal bupivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05140499 — Phase 4

Postoperative Pain Research Study Groups: Single Shot Perineural Popliteal Nerve Block, Continuous perineural popliteal nerve block catheter

Postoperative Pain Clinical Trial 2023: Liposomal bupivacaine Highlights & Side Effects. Trial Name: NCT05140499 — Phase 4

Liposomal bupivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05140499 — Phase 4

Frequently Asked Questions

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

What is the current approximate enrollment rate for this trial?

"Affirmative. Information hosted on clinicaltrials.gov shows that this medical trial, which was initially posted on August 15th 2022 is still recruiting patients. Approximately 30 people must be gathered from a single medical centre."

Answered by AI

Are there any independent investigations concerning the efficacy of Continuous perineural popliteal nerve block catheter?

"At the moment, there are 109 clinical trials related to Continuous perineural popliteal nerve block catheter. Out of these investigations, 18 have made it to Phase 3 development and 144 hospitals across the US are now involved in furthering this research. The majority of studies being conducted focus on Philadelphia, Pennsylvania as their centrepoint."

Answered by AI

What are the risks and benefits associated with Continuous perineural popliteal nerve block catheter for patients?

"There is sufficient evidence to suggest that continuous perineural popliteal nerve block catheter is safe, thus we rate it at 3 on our scale. This Phase 4 trial demonstrates the treatment's approval."

Answered by AI

What medical issues can be addressed through the implementation of a Continuous perineural popliteal nerve block catheter?

"Through the application of Continuous perineural popliteal nerve block catheter, medical professionals can address a variety of conditions such as pemphigus, acute nonspecific tenosynovitis, and general anesthesia."

Answered by AI

Is this clinical trial currently seeking participants?

"As per the clinicaltrials.gov database, this trial is still in search of subjects which was initially posted on August 15th 2022 and recently refreshed on August 31st 2022."

Answered by AI

Recent research and studies

Regional Anesthesia and Pain MedicineJournal

Randomized Prospective Study Comparing Preoperative Epidural and Intraoperative Perineural Analgesia for the Prevention of Postoperative Stump and Phantom Limb Pain Following Major Amputation

Lambert, A. 2001. “Randomized Prospective Study Comparing Preoperative Epidural and Intraoperative Perineural Analgesia for the Prevention of Postoperative Stump and Phantom Limb Pain Following Major Amputation”. Regional Anesthesia and Pain Medicine. BMJ. doi:10.1053/rapm.2001.23934.

The Clinical Journal of PainJournal

Incidence of Phantom Phenomena Including Phantom Limb Pain 6 Months After Major Lower Limb Amputation in Patients with Peripheral Vascular Disease

Richardson, Cliff, Sheila Glenn, Turo Nurmikko, and Maureen Horgan. 2006. “Incidence of Phantom Phenomena Including Phantom Limb Pain 6 Months After Major Lower Limb Amputation in Patients with Peripheral Vascular Disease”. The Clinical Journal of Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.ajp.0000177793.01415.bd.

Journal of Clinical AnesthesiaJournal

The Efficacy of Postoperative Perineural Infusion of Bupivacaine and Clonidine After Lower Extremity Amputation in Preventing Phantom Limb and Stump Pain

Madabhushi, Lakshmi, Scott S. Reuben, Robert B. Steinberg, and John Adesioye. 2007. “The Efficacy of Postoperative Perineural Infusion of Bupivacaine and Clonidine After Lower Extremity Amputation in Preventing Phantom Limb and Stump Pain”. Journal of Clinical Anesthesia. Elsevier BV. doi:10.1016/j.jclinane.2006.07.008.

Journal of Clinical AnesthesiaJournal