TERMINATED

Liposomal Bupivacaine vs Continuous Nerve Catheters for Below the Knee Amputations

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-08-15
Study Completion:2025-12-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05140499

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * American Society of Anesthesiologists Physical Status Classification I-IV
  2. * Scheduled for primary amputation or stump revision
  3. * English speaking
  1. * Patients unable to cooperate or consent to the study
  2. * Allergy to local anesthetics
  3. * Existing infection at planned needle insertion site
  4. * BMI \> 40kg/m2
  5. * Patients with a history of coagulopathy
  6. * Emergency amputations
  7. * Contralateral amputations
  8. * Patients with a substance use disorder diagnosis
  9. * Patients on opioids \>90 morphine milligram equivalents (MME)/day

Contacts and Locations

Principal Investigator

Aurora Quaye, MD
PRINCIPAL_INVESTIGATOR
MaineHealth

Study Locations (Sites)

Maine Medical Center
Portland, Maine, 04102
United States

Collaborators and Investigators

Sponsor: Aurora Quaye

  • Aurora Quaye, MD, PRINCIPAL_INVESTIGATOR, MaineHealth

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-15
Study Completion Date2025-12-23

Study Record Updates

Study Start Date2022-08-15
Study Completion Date2025-12-23

Terms related to this study

Additional Relevant MeSH Terms

  • Pain, Postoperative
  • Amputation