Liposomal Bupivacaine Versus Continuous Peripheral Nerve Blocks for Analgesia Following Ankle Surgery
Other study identifiers
Sponsor study identifier
interventional
140
1 country
1
Study Start
June 23, 2025
Actual (reported)Primary Completion
June 22, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 22, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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 provide potent analgesia, their duration is measured in hours while post-surgical pain usually outlasts this duration. Continuous peripheral nerve blocks prolong analgesia but may possibly be replaced with liposomal bupivacaine with a reported duration of up to 72-96 hours (Schwartz. J Clin Anesth 2024). In comparison to continuous peripheral nerve blocks, liposomal bupivacaine eliminates a time-consuming catheter insertion as well as the risks of catheter dislodgement, localized infection, local anesthetic leakage, and infusion pump malfunction. Furthermore, liposomal bupivacaine significantly reduces the burden on both patients and healthcare providers as it does not require the use of a portable infusion pump, local anesthetic reservoir, or perineural catheter to be carried, managed, or eventually removed. Notably, the potential for local anesthetic-induced myotoxicity, and cardiac/neurologic toxicity is reduced or negated altogether. And the cost of liposome bupivacaine is less than the combined cost of a catheter set, insertion equipment, portable infusion pump, large reservoir of local anesthetic, and healthcare provider oversight. Therefore, should a single injection of liposomal bupivacaine be demonstrated to provide at least non-inferior analgesia and opioid sparing as a continuous peripheral nerve block, it would be a far superior analgesic benefiting patients, providers, hospitals, and payers such as Medicare and private health insurance. Randomized, active-controlled clinical trials are required to compare the newer liposomal bupivacaine to continuous peripheral nerve blocks. The ultimate objective of the proposed research study is to determine if liposomal bupivacaine in a peripheral nerve block is at least non-inferior to a continuous peripheral nerve block following moderate-to-severely painful ankle surgery. This is a single-center clinical trial. The investigators will randomize participants to either a liposomal bupivacaine combined with unencapsulated bupivacaine single-injection popliteal-sciatic and saphenous nerve block group, or single injections of unencapsulated bupivacaine followed by a continuous popliteal-sciatic bupivacaine infusion.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- enrolling by invitation
- Estimated enrollment
- 140 participants
- Study completion date
June 22, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
- Listed locations
- 1 countries · 1 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
May 20, 2025
Actual (reported)First Posted
May 29, 2025
Actual (reported)Study Start
June 23, 2025
Actual (reported)Primary Completion
June 22, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 22, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
- Last Updated
- September 16, 2026
- Status Verified
- September 2026
- Last Update Submitted
- September 14, 2026