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

Conditions

• Moderate-to-severely Painful Ankle Surgery

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Popliteal nerve block including liposomal bupivacaine — DRUG
  10 mL of unencapsulated bupivacaine 0.375% and 10 mL of liposomal bupivacaine 1.33% (Exparel, Pacira BioSciences, Tampa, Florida) admixed within a 20 mL syringe.
• Adductor canal nerve block including liposomal bupivacaine — DRUG
  10 mL of unencapsulated bupivacaine 0.375% and 10 mL of liposomal bupivacaine 1.33% (Exparel, Pacira BioSciences, Tampa, Florida) admixed within a 20 mL syringe.
• Continuous popliteal nerve block with normal saline — DRUG
  A perineurial infusion of normal saline (basal rate 5 mL/h; patient-controlled bolus of 4 mL; 30 minute lockout) with the reservoir (500 mL) and pump provided by the Investigational Drug Service and continued until postoperative day 3 or until the reservoir is exhausted.
• Popliteal nerve block with exclusively unencapsulated bupivacaine — DRUG
  20 mL of unencapsulated bupivacaine 0.375% with epinephrine (1:400,000) within a 20 mL syringe.
• Adductor canal nerve block with exclusively unencapsulated bupivacaine — DRUG
  20 mL of unencapsulated bupivacaine 0.375% with epinephrine (1:400,000) within a 20 mL syringe.
• Continuous popliteal nerve block with unencapsulated bupivacaine — DRUG
  A perineurial infusion of unencapsulated bupivacaine 0.125% (basal rate 5 mL/h; patient-controlled bolus of 4 mL; 30 minute lockout) with the reservoir (500 mL) and pump provided by the Investigational Drug Service and continued until postoperative day 3 or until the reservoir is exhausted.

Study Details

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.

Key Dates

Start date

Jun 23, 2025

Status verified

Oct 2025

Primary completion

Jun 22, 2027

Completion

Jun 22, 2027

Study Design

Enrollment

140 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Liposomal Bupivacaine (Experimental)
  Popliteal-sciatic nerve block: 10 mL of unencapsulated bupivacaine 0.375% and 10 mL of liposomal bupivacaine 1.33% (Exparel, Pacira BioSciences, Tampa, Florida) admixed within a 20 mL syringe. Adductor canal (saphenous) nerve block: 10 mL of unencapsulated bupivacaine 0.375% and 10 mL of liposomal bupivacaine 1.33% (Exparel, Pacira BioSciences, Tampa, Florida) admixed within a 20 mL syringe. Postoperative perineural infusion: Basal rate 5 mL/h; patient-controlled bolus of 4 mL; 30 minute lockout; and reservoir with normal saline (500 mL).
• Active Comparator: Unencapsulated Bupivacaine (Control)
  Popliteal-sciatic nerve block: 20 mL of unencapsulated bupivacaine 0.375% with epinephrine (1:400,000) within a 20 mL syringe. Adductor canal (saphenous) nerve block: Standard-of-Care Group: 20 mL of unencapsulated bupivacaine 0.375% with epinephrine (1:400,000) within a 20 mL syringe. Postoperative perineural infusion: Basal rate 5 mL/h; patient-controlled bolus of 4 mL; 30 minute lockout; and reservoir of unencapsulated bupivacaine 0.125% (500 mL).

Primary Outcome Measure

First postoperative week daily average pain level [ Time Frame: Postoperative days 1-7 ]

Locations (1)

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