Status:
ENROLLING_BY_INVITATION
Liposomal Bupivacaine Versus Continuous Peripheral Nerve Blocks for Analgesia Following Ankle Surgery
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Pacira Biosciences
Conditions:
Moderate-to-severely Painful Ankle Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Postoperative pain remains undertreated. Opioids have well-known limitations for both individuals and society, and while single-injection peripheral nerve blocks with unencapsulated local anesthetic p...
Detailed Description
For individuals of childbearing potential, a sample of urine will be collected before any study interventions to confirm a non-pregnant state (this is standard procedure for all surgical patients). Pa...
Eligibility Criteria
Inclusion
- Adult patients of at least 18 years of age
- Undergoing a primary, unilateral, moderate-to-severely painful ankle surgery
- Planned single-injection adductor canal nerve block and popliteal-sciatic catheter
- Weight \> 50 kg (to minimize the risk of local anesthetic toxicity)
Exclusion
- chronic opioid or tramadol use: daily oxycodone equivalents \> 20 mg for \> 4 weeks
- neuro-muscular deficit of the surgical limb
- moderate pain (NRS \> 3) in an anatomic location other than the surgical site
- surgery outside the sciatic and saphenous nerve distributions
- history of opioid misuse
- inability to communicate with the investigators
- inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access)
- incarceration
- pregnancy
- allergy to amide local anesthetics or other study medication
- active lower extremity infection or other contraindications to a peripheral nerve catheter
Key Trial Info
Start Date :
June 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 22 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06995352
Start Date
June 23 2025
End Date
June 22 2027
Last Update
October 20 2025
Active Locations (1)
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1
University of California San Diego
La Jolla, California, United States, 92137