drugset / Trial / NCT07246642

IPP Placement & Intracavernosal Block

NCT07246642

Phase 4 Not yet recruiting 100 enrolled Wake Forest University Health Sciences
RandomizedParallel-groupDouble-blindTreatment

Summary

The inflatable penile prosthesis (IPP) is the gold standard for surgical management of erectile dysfunction (ED) and there is no consensus on the best postoperative pain management regimen. In the wake of the opioid epidemic, postoperative pain management is heavily scrutinized. The National Institute of Health estimated over 81,000 individuals died following overdose of any opioids in 2022 alone; of these, over 14,000 deaths were linked to prescription opioids. Thus, strategies to minimize postoperative pain should not only improve patient experience but also lessen the need to escalate to opioid usage.

Timeline

Start
2026-09
Primary completion
2027-09
Completion
2027-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 50 mg Other
Subject Bupivacaine Other / unclassified 133 mg Other

Indications