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Search / Trial NCT06995352

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

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · May 20, 2025

Trial Information

Current as of July 27, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

This clinical trial is studying a new pain relief method for patients undergoing ankle surgery. It compares a single injection of liposomal bupivacaine, which can last for up to 72-96 hours, to a continuous peripheral nerve block that requires a catheter and pump to deliver pain medication over time. The goal is to see if the liposomal bupivacaine is at least as effective as the continuous option while being easier to manage and having fewer risks, such as infections or equipment failure.

To participate in the trial, you need to be at least 18 years old, scheduled for ankle surgery that is expected to cause moderate to severe pain, and weigh more than 50 kg. You won't be eligible if you have certain conditions, like chronic opioid use, a history of opioid misuse, or if you're pregnant. If you join the study, you will be randomly assigned to receive either the new injection or the standard continuous nerve block. The trial aims to make pain management after surgery simpler and safer for everyone involved.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Adult patients of at least 18 years of age
  • 2. Undergoing a primary, unilateral, moderate-to-severely painful ankle surgery
  • 3. Planned single-injection adductor canal nerve block and popliteal-sciatic catheter
  • 4. Weight \> 50 kg (to minimize the risk of local anesthetic toxicity)
  • Exclusion Criteria:
  • 1. chronic opioid or tramadol use: daily oxycodone equivalents \> 20 mg for \> 4 weeks
  • 2. neuro-muscular deficit of the surgical limb
  • 3. moderate pain (NRS \> 3) in an anatomic location other than the surgical site
  • 4. surgery outside the sciatic and saphenous nerve distributions
  • 5. history of opioid misuse
  • 6. inability to communicate with the investigators
  • 7. inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access)
  • 8. incarceration
  • 9. pregnancy
  • 10. allergy to amide local anesthetics or other study medication
  • 11. active lower extremity infection or other contraindications to a peripheral nerve catheter

About University Of California, San Diego

The University of California, San Diego (UCSD) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust focus on translational medicine, UCSD leverages its interdisciplinary approach to explore groundbreaking therapies and interventions across a wide range of medical fields. The university's state-of-the-art facilities and collaboration with top-tier faculty and researchers ensure a comprehensive and ethical framework for conducting clinical trials, ultimately aiming to enhance patient outcomes and contribute to the global body of medical knowledge.

Locations

La Jolla, California, United States

Patients applied

0 patients applied

Trial Officials

Brian M Ilfeld, MD, MS

Principal Investigator

University of California, San Diego

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported