Liposomal Bupivacaine vs Continuous Nerve Catheters for Below the Knee Amputations

Ryan Mountjoy, MD

Status and phase: Enrolling; Phase 4

Conditions: Pain, Postoperative; Amputation

Treatments: Drug: Liposomal bupivacaine; Drug: Bupivacaine Hydrochloride 0.5 % Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05140499

1807862-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Single Shot Perineural Popliteal Nerve Block

Active Comparator group

Description:

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

Treatment:

Drug: Liposomal bupivacaine

Continuous perineural popliteal nerve block catheter

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine Hydrochloride 0.5 % Injectable Solution