Liposomal Bupivacaine vs Continuous Nerve Catheters for Below the Knee Amputations

January 23, 2026 updated by: Aurora Quaye

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Lower extremity amputation is a common surgical procedure often due to limb ischemia or complications related to diabetes mellitus. Managing postoperative pain can be quite challenging in this patient population and persistent post-surgical pain is not uncommon. Peripheral nerve catheters (PNCs) that deliver a continuous infusion of local anesthetic have been shown to provide analgesic benefit dependent upon infusion duration and in the absence of catheter malfunction. Unfortunately, PNCs can be difficult to place and rates of dislodgement are estimated at 30%. Single shot regional nerve blocks using liposomal bupivacaine are much easier to perform than PNCs and can provide up to 72 hours of pain relief, eliminating the need for catheter placement. To date, no study has investigated the effects of liposomal bupivacaine compared to PNCs for post-surgical pain control. In this pilot study, we intend to compare pain scores, opioid consumption, and length of stay in patients randomized to both treatment strategies. We also intend to conduct an exploratory analysis investigating incidence of phantom limb pain one month following surgery. Our results will inform the design of a larger powered study to investigate treatment effects.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • American Society of Anesthesiologists Physical Status Classification I-IV
  • Scheduled for primary amputation or stump revision
  • English speaking

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Single Shot Perineural Popliteal Nerve Block
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
Drug: Liposomal bupivacaine
Popliteal nerve block
Other Names:
  • Exparel
Active Comparator: Continuous perineural popliteal nerve block catheter
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
Drug: Bupivacaine Hydrochloride 0.5 % Injectable Solution
Continuous nerve catheter
Other Names:
  • conventional bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Assessed by Numerical Rating Scale (NRS)
Time Frame: 72 hours post-operatively
Average NRS pain scores (0-10, 0=no pain, 10=worst possible pain)
72 hours post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Consumption
Time Frame: 72 hours post-operatively
Total amount of opioid medication given, in morphine milligram equivalents
72 hours post-operatively
Post-operative Length of Stay
Time Frame: Measured from surgical stop time to discharge time, an average of 5 days.
Post-operative length of stay in hours
Measured from surgical stop time to discharge time, an average of 5 days.
Post-operative Pain Assessed by the Short Form McGill Pain Questionnaire-2 (SFMPQ-2)
Time Frame: 30 days following surgery
Total SFMPQ-2 score (low score of 0, no pain to a high score of 220, worst possible pain)
30 days following surgery
Phantom Limb Pain Assessed Using Questions From the Trinity Amputation and Prosthesis Experiences Scales-Revised (TAPES-R)
Time Frame: 30 days following surgery
Phantom Limb Pain was measured using questions 4 and 5 from Part II of the TAPES-R (scores can range from 0, no pain, to 22, severe pain)
30 days following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aurora Quaye

Collaborators

MaineHealth

Investigators

  • Principal Investigator: Aurora Quaye, MD, MaineHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Actual)

November 20, 2025

Study Completion (Actual)

December 23, 2025

Study Registration Dates

First Submitted

October 25, 2021

First Submitted That Met QC Criteria

November 19, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1807862-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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