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.
Will I have to stop taking my current medications?
The trial requires that you are not taking prescribed narcotic medications at the time of surgery. If you are on such medications, you would need to stop them to participate.
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
Trial Overview
The trial is testing a mixture of Exparel and bupivacaine as a method for managing pain after IPP placement. It seeks to determine if this non-opioid approach can reduce postoperative discomfort effectively.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
10cc Exparel/bupivacaine mixture will be injected into each corporal body (left and right for a total of 20cc)
10cc of normal saline will be injected into each corporal body (left and right for a total of 20cc)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
Citations
Intraoperative Intracavernosal Liposomal Bupivacaine ...
Their study found that 43% of the patients treated with pudendal nerve block experienced severe aching pain over the perineum for a couple of weeks ...
2.
cdn.amegroups.cn
cdn.amegroups.cn/journals/amepc/files/journals/3/articles/58534/public/58534-PB5-3394-R2.pdfLong-acting liposomal bupivacaine and postoperative ...
Two patients (7%) required opioids during the first two days after surgery. 27/28 (96%) were satisfied or highly satisfied with postoperative ...
3.
hopitalduvalais.ch
hopitalduvalais.ch/fileadmin/files/disciplines/anesthesiologie/CHVR/Publications/Ngyen_2023_Postoperative_Efficacy_Liposomal.pdfThe postoperative analgesic efficacy of liposomal ...
CONCLUSIONS There is moderate level evidence that liposomal bupivacaine reduces rest pain scores by 0.9 out of 10 units, when compared with long ...
4.
dig.pharmacy.uic.edu
dig.pharmacy.uic.edu/faqs/2023-2/february-2023-faqs/does-the-available-data-support-the-use-of-liposomal-bupivacaine-for-analgesia-during-vasectomy-and-vasectomy-reversal-procedures/Does the available data support the use of liposomal ...
Authors reported that liposomal bupivacaine significantly reduced immediate and delayed postoperative pain intensity scores, delayed the time to first ...
Long-acting liposomal bupivacaine decreases inpatient ...
The use of a new ERSB in penile prosthesis implants did lead to reduced narcotic consumption with comparable postoperative pain control to the non-ERSB group.
NCT07212114 | Efficacy of EXPAREL vs. Bupivacaine
The objective is to determine whether the EXPAREL-based regimen provides more effective and longer-lasting analgesia compared to bupivacaine ...
Safety and Efficacy of Long-Acting Liposomal Bupivacaine ...
This study evaluates the tolerability and efficacy of preoperative dorsal penile nerve block with Exparel plus bupivacaine hydrochloride in children>6 years old
NDA 022496, S009 EXPAREL Assessment of Efficacy Data ...
• Efficacy results from local exposure of bupivacaine from EXPAREL. • Safety is based on local effects and systemic bupivacaine exposure. Page ...
Safety of liposome extended-release bupivacaine for ...
Approximately 21–30% of patients experience moderate to severe pain in the postoperative period, which may have a significant impact on recovery rate, standard ...
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