Liposomal Bupivacaine vs Drug Combination for Total Knee Replacement
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine which combination of medications offers the longest-lasting pain relief after knee replacement surgery. It compares liposomal bupivacaine, a long-acting local anesthetic, with a mix of bupivacaine, clonidine, epinephrine, buprenorphine, and dexamethasone. Participants will report their pain levels at various times during the study. Ideal candidates are those scheduled for their first knee replacement who have not recently used strong opioids. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment can benefit more patients.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are using opioids or have allergies to certain study medications, you may not be eligible to participate.
What is the safety track record for these treatments?
Research has shown that liposomal bupivacaine is generally safe for surgeries like total knee replacement. One study found that when used on both knees simultaneously, drug levels in the body remained well below harmful levels, indicating good tolerance.
For the combination of bupivacaine, clonidine, epinephrine, buprenorphine, and dexamethasone, studies have shown it effectively reduces pain. Specifically, one study noted that this mix provides longer pain relief after surgery compared to using just bupivacaine. No major safety issues have been reported.
Both treatments have been used in surgeries and appear safe. However, always discuss any treatment concerns with a doctor.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for total knee replacement because they offer innovative approaches to pain management. Liposomal bupivacaine is unique because it provides a sustained release of anesthetic directly at the surgical site, potentially leading to longer-lasting pain relief compared to traditional bupivacaine. The combination treatment of bupivacaine with clonidine, epinephrine, buprenorphine, and dexamethasone (BPV-CEBD) aims to enhance pain control by leveraging multiple mechanisms, such as reducing inflammation and prolonging anesthesia duration. These approaches could improve post-surgical recovery and reduce reliance on opioids, addressing a significant need in current pain management strategies.
What evidence suggests that this trial's treatments could be effective for pain relief in total knee replacement?
This trial will compare liposomal bupivacaine with a combination of bupivacaine, clonidine, epinephrine, buprenorphine, and dexamethasone for pain management in total knee replacement. Research has shown that liposomal bupivacaine might not offer significantly better pain relief than regular bupivacaine after knee surgery. However, some studies suggest it can reduce the need for additional pain medication afterward. In contrast, the combination of bupivacaine, clonidine, epinephrine, buprenorphine, and dexamethasone has provided longer-lasting pain relief, up to 39 hours. This mix appears to reduce pain more effectively than some other options for knee and hip surgeries. Both treatments in this trial aim to improve recovery and pain management for patients undergoing knee replacements.13456
Who Is on the Research Team?
Afua Gyamfi, MD
Principal Investigator
Atrium Health Wake Forest Baptist
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 undergoing primary total knee replacement surgery, who are relatively healthy (ASA category 1 to 3) and will receive a specific spinal anesthetic. It's not for those with recent heavy opioid use, allergies to study drugs, poorly controlled diabetes, planned general anesthesia, or a history of peripheral neuropathy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either liposomal bupivacaine or a combination of bupivacaine, clonidine, epinephrine, buprenorphine, and dexamethasone for adductor canal and iPACK blocks during total knee arthroplasty
Post-operative Monitoring
Pain scores and other secondary data are collected at various intervals post-surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bupivacaine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor