TerminatedPhase 4

Liposomal Bupivacaine vs Continuous Nerve Catheters for Below the Knee Amputations

Stopped: Difficulty with enrollment

United States11 participantsStarted 2022-08-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Pain Assessed by Numerical Rating Scale (NRS)

Timeframe: 72 hours post-operatively

Trial details

NCT IDNCT05140499

SponsorAurora Quaye

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-20

Results submitted2026-01-08

View on ClinicalTrials.gov More Pain, Postoperative trials