Liposomal Bupivacaine for Pain After Ankle Surgery

Overseen By Baharin Abdullah, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Diego

Must not be taking: Opioids, Tramadol

Disqualifiers: Opioid misuse, Neuro-muscular deficit, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 3 days

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Brian M Ilfeld, MD, MS

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are having a specific type of painful ankle surgery and weigh more than 50 kg. It's not for those with moderate pain elsewhere, opioid misuse history, communication issues with the team, incarceration, pregnancy, amide anesthetic allergy, leg infections or on chronic opioids.

Inclusion Criteria

I am scheduled for specific nerve block procedures in my leg.

I am 18 years old or older.

I am having a major ankle surgery on one side that is expected to be quite painful.

Exclusion Criteria

Incarceration

Pregnancy

History of opioid misuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either liposomal bupivacaine or continuous peripheral nerve blocks following ankle surgery

3 days

Inpatient stay

Postoperative Monitoring

Participants are monitored for pain levels and opioid consumption daily

7 days

Daily phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Adductor canal nerve block including liposomal bupivacaine
• Adductor canal nerve block with exclusively unencapsulated bupivacaine
• Continuous popliteal nerve block with normal saline
• Continuous popliteal nerve block with unencapsulated bupivacaine
• Popliteal nerve block including liposomal bupivacaine
• Popliteal nerve block with exclusively unencapsulated bupivacaine

Trial Overview The study compares two types of nerve blocks after ankle surgery: one using liposomal bupivacaine (a long-lasting numbing medication) and another using continuous infusion of regular bupivacaine. The goal is to see if a single shot of the new drug can match or beat the standard treatment in controlling pain.

How Is the Trial Designed?

Group I: Liposomal Bupivacaine (Experimental) Experimental Treatment 3 Interventions

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).

Group II: Unencapsulated Bupivacaine (Control) Active Control 3 Interventions

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).

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Pacira Biosciences

Collaborator

Trials

1

Recruited

30+