Liposomal Bupivacaine for Postoperative Pain in Shoulder Surgery

Overseen By Johnny K Lee, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Johnny K. Lee

Disqualifiers: Pregnancy, Severe liver/kidney disease, 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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding liposomal bupivacaine (a long-acting form of the local anesthetic bupivacaine) to standard bupivacaine improves pain management after shoulder surgery. Researchers will compare pain levels, recovery quality, and the need for painkillers over five days in patients undergoing shoulder replacement surgery. The trial will test two pain relief mixtures: one with only bupivacaine and another with both liposomal bupivacaine and bupivacaine. Individuals planning to undergo shoulder replacement surgery and able to give consent in English may be suitable candidates for this trial. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for more patients, offering participants the chance to contribute to valuable insights.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research has shown that liposomal bupivacaine is generally safe and effective for managing pain after shoulder surgery. Many studies have found that it can help reduce pain and speed up recovery. For instance, one study found that using liposomal bupivacaine with a nerve block reduced pain after surgery more effectively than a placebo. Another study suggested it has fewer side effects compared to other pain relief methods. These findings suggest that liposomal bupivacaine is a reliable option for managing pain after surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about liposomal bupivacaine for postoperative pain in shoulder surgery because it offers extended pain relief compared to standard bupivacaine. Unlike regular bupivacaine, which typically provides relief for a few hours, liposomal bupivacaine is designed to release the medication slowly over time, potentially reducing the need for additional pain medication. This can be a game-changer for patients, as it might lead to better pain management with fewer doses, improving comfort and recovery after surgery.

What evidence suggests that Liposomal Bupivacaine might be an effective treatment for postoperative pain in shoulder surgery?

Research has shown that liposomal bupivacaine, which participants in this trial may receive, helps manage pain after surgery, particularly in shoulder surgeries. Studies have found it significantly lowers pain levels 24 to 72 hours post-surgery. Patients using liposomal bupivacaine often require fewer opioids, which are strong painkillers with potential side effects. This treatment also links to fewer major complications. Liposomal bupivacaine is an approved method for managing pain in surgical settings. ^{1 2 6 7 8}

Who Is on the Research Team?

Johnny K Lee, MD

Principal Investigator

Endeavor Health

Are You a Good Fit for This Trial?

This trial is for adults aged 18-90, weighing at least 60 kg, undergoing shoulder replacement surgery. They must understand English to give consent. It's not for those allergic to local anesthetics, pregnant women, patients with severe liver/kidney disease or on dialysis, and those having multiple surgeries in one hospital stay.

Inclusion Criteria

Must be able to consent in English

I weigh 60 kg or more.

I am either male or female.

Exclusion Criteria

I need surgery urgently.

I am not allergic to any local anesthetics used in the trial.

I cannot use liposomal bupivacaine due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive interscalene blocks with or without liposomal bupivacaine during shoulder arthroplasty

1 day

1 visit (in-person, day of surgery)

Postoperative Monitoring

Participants are monitored for pain scores, opioid use, and quality of recovery for 5 days postoperatively

5 days

Daily monitoring (virtual or in-person)

Follow-up

Participants are monitored for adverse reactions and long-term outcomes

30 days

1 visit (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine
• Liposomal Bupivacaine

Trial Overview The study compares pain control and opioid use after shoulder surgery between two groups: one receiving regular bupivacaine and the other getting liposomal bupivacaine mixed with a lower dose of regular bupivacaine plus saline. Participants are randomly assigned to either group without knowing which treatment they receive.

How Is the Trial Designed?

Group I: Plain Bupivacaine Group Experimental Treatment 1 Intervention

36 mL (180 mg) 0.5% bupivacaine

Group II: Liposomal Bupivacaine Group Experimental Treatment 1 Intervention

10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg)

Bupivacaine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in European Union as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in Canada as Sensorcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Who Is Running the Clinical Trial?

Johnny K. Lee

Lead Sponsor

Trials

1

Recruited

120+

Endeavor Health

Collaborator

Trials

135

Recruited

742,000+

NorthShore University HealthSystem

Collaborator

Trials

134

Recruited

740,000+

Citations

1. journaloei.scholasticahq.com journaloei.scholasticahq.com/article/117497-liposomal-bupivacaine-in-managing-postoperative-pain-following-shoulder-surgery

Liposomal Bupivacaine in Managing Postoperative Pain ... The use of LB as part of a multimodal approach to postoperative pain results in diminished use of opioids, reduced pain, and decreased length of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02472314

Exparel for Postoperative Pain Management in Shoulder ... liposomal bupivacaine analgesia will provide improved postoperative pain control, reduction in amount of opioid supplementation, decreased complications and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12277084/

Clinical Effectiveness of Perineural Liposomal Bupivacaine is ... PNBs are commonly used to decrease total and rescue opioid consumption, offer comfortable postoperative care settings, improve analgesic ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1877056825000374

Liposomal Bupivacaine After Arthroscopic Rotator Cuff ... The current meta-analysis of level 1 evidence revealed that LB significantly decreases postoperative pain scores 24 to 72 hours and reduces ...

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

Practical Considerations for Liposomal Bupivacaine Use in ... Within shoulder surgery, a 2017 study showed liposomal bupivacaine to have a lower cost ($289 vs. $1,559) and 4 times fewer major complications ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11389883/

Addition of Liposomal Bupivacaine to Standard ... Addition of liposomal bupivacaine in the interscalene brachial plexus block was shown to reduce postoperative pain after shoulder surgery compared to placebo ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352587825001160

Research progress of liposomal bupivacaine and its value ... These findings suggest that LB may be a safe and promising agent for prolonging postoperative analgesia and minimizing donor site pain. Some studies have ...

8. jshoulderelbow.org jshoulderelbow.org/article/S1058-2746(16)30674-7/fulltext

A prospective randomized trial to identify the optimal ... Our results demonstrated a lower complication rate and decreased cost for liposomal bupivacaine over CISB for postoperative pain relief after shoulder ...