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NOT YET RECRUITING
NCT07246642
PHASE4

IPP Placement & Intracavernosal Block

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

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.

Official title: Randomized Controlled Trial of Intracorporal Local Anesthesia vs Saline Prior to Placement of Inflatable Penile Prosthesis Placement

Key Details

Gender

MALE

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-05

Completion Date

2027-10

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DRUG

Exparel/bupivacaine mixture

10cc of Exparel (133 mg, 1.3%) with 10cc of 0.5% standard bupivacaine (50 mg )for total volume of 20cc into the corpora immediately prior to placement of corporotomy stay sutures.

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States