Exparel/Bupivacaine Mixture for Postoperative Pain in Erectile Dysfunction Surgery
(IPP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how well a mixture of Exparel and bupivacaine (a local anesthetic) manages pain after surgery for erectile dysfunction (ED). The goal is to find better pain management methods without relying on potentially risky opioids. Participants will receive either the Exparel/bupivacaine mixture or a saline solution for comparison. Men undergoing their first inflatable penile prosthesis surgery at Lexington Medical Center, who are not on narcotics and have no liver or kidney issues, might be suitable for this study. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.
What is the safety track record for the Exparel/bupivacaine mixture?
Research has shown that the Exparel/bupivacaine mixture is generally safe for patients undergoing certain surgeries. One study found that using Exparel during penile prosthesis surgery was safe and effective. Another study examined Exparel in children over six years old and found it to be well-tolerated.
Exparel is a long-lasting form of bupivacaine, an anesthetic commonly used for pain management. Its safety primarily depends on its action at the injection site and the absorption of bupivacaine in the body. Although some patients may still experience moderate to severe pain after surgery, Exparel can effectively help manage this pain.
Overall, studies suggest that the Exparel/bupivacaine mixture is well-tolerated, with no major safety concerns reported.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the Exparel/bupivacaine mixture for postoperative pain relief in erectile dysfunction surgery because it offers a longer-lasting effect compared to standard options like traditional bupivacaine alone. This mixture combines Exparel, a liposome-based formulation of bupivacaine, which allows for a slow release of the anesthetic, providing extended pain control. Unlike other treatments that may require more frequent dosing, this approach could reduce the need for additional pain medications, enhancing patient comfort and recovery.
What evidence suggests that the Exparel/bupivacaine mixture might be an effective treatment for postoperative pain in erectile dysfunction surgery?
Research has shown that the Exparel/bupivacaine mixture, which participants in this trial may receive, can effectively manage post-surgical pain. Studies have found that liposomal bupivacaine, a key ingredient, significantly reduces pain levels. In one study, only 7% of patients required opioids in the first two days, and 96% reported satisfaction with their pain relief. Another study demonstrated that this treatment reduced pain scores by nearly 1 point on a 10-point scale. These findings suggest that the Exparel/bupivacaine mixture may help reduce opioid use while maintaining patient comfort.16789
Who Is on the Research Team?
Ryan Terlecki, MD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
This trial is for men with erectile dysfunction who are undergoing inflatable penile prosthesis (IPP) surgery. The study aims to find effective pain management post-surgery without relying on opioids, due to the high risk of addiction and overdose.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo IPP placement with either intracavernosal local anesthesia or saline
Immediate Postoperative Monitoring
Serum bupivacaine levels are measured at 1 hour and 24 hours after surgery
Follow-up
Participants are monitored for postoperative pain, complications, and opioid usage
What Are the Treatments Tested in This Trial?
Interventions
- Exparel/bupivacaine mixture
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor