Liposomal Bupivacaine vs Continuous Nerve Catheters for Below the Knee Amputations

Phase 4

Recruiting

• Conditions: Pain, Postoperative; Amputation
• Interventions: Drug: Liposomal bupivacaine; Drug: Bupivacaine Hydrochloride 0.5 % Injectable Solution

• Registration Number: NCT05140499
• Lead Sponsor: Ryan Mountjoy, MD

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-11-19
• Study First Posted: 2021-12-01
• Study Start: 2022-08-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Shot Perineural Popliteal Nerve Block	Liposomal bupivacaine	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
Continuous perineural popliteal nerve block catheter	Bupivacaine Hydrochloride 0.5 % Injectable Solution	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

Primary Outcome Measures

Name	Time	Method
Pain assessed by Numerical Rating Scale (NRS)	72 hours post-operatively	Average NRS pain scores (0-10, 0=no pain, 10=worst possible pain)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Maine Medical Center; 🇺🇸 Portland, Maine, United States