Liposomal Bupivacaine vs Continuous Nerve Catheters for Below the Knee Amputations

Description

Through this pilot prospective trial, we aim to obtain preliminary data investigating the effectiveness of perineural catheters and liposomal bupivacaine, both currently accepted as standard care at Maine Medical Center, for the management of post-limb amputation pain. We will use the data that we collect to inform the design of a larger, appropriately powered study.

Conditions

Pain, Postoperative, Amputation

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Study Overview

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Study Details

Study overview

Through this pilot prospective trial, we aim to obtain preliminary data investigating the effectiveness of perineural catheters and liposomal bupivacaine, both currently accepted as standard care at Maine Medical Center, for the management of post-limb amputation pain. We will use the data that we collect to inform the design of a larger, appropriately powered study.

A Prospective, Randomized Trial of Liposomal Bupivacaine Compared to Continuous Nerve Catheters on Pain Control and Post-Operative Opioid Use in Receiving Popliteal Nerve Blocks for Below the Knee Amputation

Liposomal Bupivacaine vs Continuous Nerve Catheters for Below the Knee Amputations

Condition
Pain, Postoperative
Intervention / Treatment

-

Contacts and Locations

Portland

Maine Medical Center, Portland, Maine, United States, 04102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * American Society of Anesthesiologists Physical Status Classification I-IV
  • * Scheduled for primary amputation or stump revision
  • * English speaking
  • * Patients unable to cooperate or consent to the study
  • * Allergy to local anesthetics
  • * Existing infection at planned needle insertion site
  • * BMI \> 40kg/m2
  • * Patients with a history of coagulopathy
  • * Emergency amputations
  • * Contralateral amputations
  • * Patients with a substance use disorder diagnosis
  • * Patients on opioids \>90 morphine milligram equivalents (MME)/day

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ryan Mountjoy, MD,

Ryan Mountjoy, MD, PRINCIPAL_INVESTIGATOR, MaineHealth

Study Record Dates

2025-01-31