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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage pain after ankle surgery using a special form of bupivacaine, a pain-relief medication, that lasts longer. Researchers aim to determine if this long-lasting version can provide pain relief comparable to the current method, which uses a continuous nerve block but requires more equipment and oversight. Participants will receive either the new liposomal bupivacaine or the standard treatment with unencapsulated bupivacaine to compare their effectiveness. This study is ideal for individuals planning moderate to severe ankle surgery who are not regular opioid users. As a Phase 4 trial, it involves an FDA-approved treatment and seeks to understand how it can benefit more patients.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you use opioids or tramadol daily in amounts greater than 20 mg of oxycodone equivalents for more than four weeks, you cannot participate.

What is the safety track record for these treatments?

A previous study showed that liposomal bupivacaine, known as EXPAREL®, is safe and effective for pain relief after surgery. Research indicates that it can reduce the need for opioids and provide longer-lasting pain control compared to traditional methods, resulting in fewer opioid-related side effects like nausea or dizziness.

Studies also show that patients using liposomal bupivacaine often report lower pain levels. The treatment is generally well-tolerated, with fewer complications than continuous nerve blocks, which require inserting a tube. This reduces risks such as infections or problems with the infusion pump.

Overall, liposomal bupivacaine offers a promising option for managing post-surgical pain with a strong safety record. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the use of liposomal bupivacaine for pain management after ankle surgery because it offers potential advantages over standard treatments like unencapsulated bupivacaine. Unlike traditional bupivacaine, this formulation includes liposomal encapsulation, which allows for a slower release of the medication, potentially providing longer-lasting pain relief with a single dose. This could mean fewer doses are needed and a reduction in the overall use of opioids post-surgery. Additionally, the use of a liposomal form might improve patient comfort and recovery times, making it a promising option for postoperative pain management.

What evidence suggests that this trial's treatments could be effective for pain after ankle surgery?

This trial will compare liposomal bupivacaine with unencapsulated bupivacaine for managing pain after ankle surgery. Research has shown that liposomal bupivacaine effectively manages post-surgical pain. Studies indicate it reduces opioid requirements and extends pain relief compared to regular bupivacaine. As a result, patients experience less pain and may need fewer painkillers. Liposomal bupivacaine works by slowly releasing the pain-relieving medicine over time, which helps maintain longer-lasting pain relief. It may also lower pain levels and reduce the likelihood of a prolonged hospital stay. Overall, it offers a promising option for managing pain after ankle surgery. ^{2 4 5 6 7}

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40916868/

Efficacy of Liposomal Bupivacaine in Ultrasound-Guided ... Conclusion: US-guided peripheral nerve blocks using liposomal bupivacaine were associated with reduced postoperative opioid consumption and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02072135

Study Details | NCT02072135 | Exparel and Ankle Surgery EXPAREL® is a long acting pain reliever. It is being given in this study to see if it provides safe and effective pain relief after ankle surgery. Because it is ...

3. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/10711007251359634

Efficacy of Liposomal Bupivacaine in Ultrasound-Guided ... US-guided peripheral nerve blocks using liposomal bupivacaine were associated with reduced postoperative opioid consumption and prolonged block ...

4. dovepress.com dovepress.com/clinical-effectiveness-of-perineural-liposomal-bupivacaine-is-not-supe-peer-reviewed-fulltext-article-JPR

Clinical Effectiveness of Perineural Liposomal Bupivacaine ... The perineural use of liposomal bupivacaine is clinically worthwhile in pain management after orthopedic surgery compared with plain bupivacaine.

5. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-023-03583-1

The use of liposomal bupivacaine in fracture surgery: a review It is commonly reported that liposomal bupivacaine has the potential to decrease pain scores, decrease length of stay, decrease opioid use, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7396112/

EXPAREL® (Long-Acting Liposomal Bupivacaine) Use for ... EXPAREL® has been used successfully to prolong postoperative pain control when applied as a wound infiltrate.

7. jbjs.org jbjs.org/reader.php?rsuite_id=1465b124-eb1a-41fc-a2ff-044d0c6a95cf

Practical Considerations for Liposomal Bupivacaine Use in ... Randomized and nonrandomized studies have also demonstrated superior pain scores and lower opioid use for liposomal bupivacaine versus ...