Liposomal Bupivacaine for Postoperative Pain in Shoulder Surgery
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.12345
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.12678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive interscalene blocks with or without liposomal bupivacaine during shoulder arthroplasty
Postoperative Monitoring
Participants are monitored for pain scores, opioid use, and quality of recovery for 5 days postoperatively
Follow-up
Participants are monitored for adverse reactions and long-term outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Bupivacaine
- Liposomal Bupivacaine
Bupivacaine is already approved in United States, European Union, Canada for the following indications:
- Local anesthesia for surgery
- Acute pain management
- Spinal anesthesia
- Local anesthesia for surgery
- Acute pain management
- Spinal anesthesia
- Local anesthesia for surgery
- Acute pain management
- Spinal anesthesia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johnny K. Lee
Lead Sponsor
Endeavor Health
Collaborator
NorthShore University HealthSystem
Collaborator