Back to search results
NCT06995352

Liposomal Bupivacaine Versus Continuous Peripheral Nerve Blocks for Analgesia Following Ankle Surgery

Enrolling by Invitation
PHASE4Ages 18+InterventionalTreatment
University of California, San Diego
~140 participants
Updated 2025-10-20 on ClinicalTrials.gov
What's tested:Popliteal nerve block including liposomal bupivacaineAdductor canal nerve block including liposomal bupivacaineContinuous popliteal nerve block with normal salinePopliteal nerve block with exclusively unencapsulated bupivacaineAdductor canal nerve block with exclusively unencapsulated bupivacaineContinuous popliteal nerve block with unencapsulated bupivacaine

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
First postoperative week daily average pain level
Measured over Postoperative days 1-7
+1 more outcome measured

Conditions

Moderate-to-severely Painful Ankle Surgery

Explore related trials

Acne surgery

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Brian M Ilfeld, MD, MS · PRINCIPAL_INVESTIGATOR · University of California, San Diego

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • First postoperative week daily average pain levelPostoperative days 1-7

    The NRS is a highly-sensitive measure of pain intensity with numbers ranging from 0 to 10, zero equivalent to no pain and 10 equivalent to the worst imaginable pain. The primary outcome measure will be a combination of daily "average" NRS and opioid consumption in oxycodone equivalents. In order to claim that liposomal bupivacaine is non-inferior to a perineural bupivacaine infusion for each postoperative day, both NRS and opioid consumption must be at least non-inferior for that day. We will use a stepwise gatekeeping statistical procedure beginning on Day 1 and progressing daily through Day 7. Using this statistical method, no adjustment in alpha will be necessary to control Type 1 error through all 7 days.

  • First postoperative week cumulative opioid consumptionPostoperative days 1-7

    Cumulative opioid consumption from recovery room discharge through postoperative day 7 measured in oxycodone equivalents. The primary outcome measure will be a combination of daily "average" NRS and opioid consumption in oxycodone equivalents. In order to claim that liposomal bupivacaine is non-inferior to a perineural bupivacaine infusion for each postoperative day, both NRS and opioid consumption must be at least non-inferior for that day. We will use a stepwise gatekeeping statistical procedure beginning on Day 1 and progressing daily through Day 7. Using this statistical method, no adjustment in alpha will be necessary to control Type 1 error through all 7 days.