IPP Placement & Intracavernosal Block

Conditions

• Erectile Dysfunction (ED)

Eligibility Criteria

Sex

MALE

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Exparel/bupivacaine mixture — DRUG
  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.

Study Details

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.

Key Dates

Start date

Sep 30, 2026

Status verified

Sep 2025

Primary completion

Sep 30, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Control Saline Arm
  10cc of normal saline will be injected into each corporal body (left and right for a total of 20cc)
• Experimental: Exparel/bupivacaine mixture Arm
  10cc Exparel/bupivacaine mixture will be injected into each corporal body (left and right for a total of 20cc)

Primary Outcome Measure

Visual Analogue Scale (VAS) Scores [ Time Frame: Hour 1 ]

Central Contacts

• Sachin Vyas
  336.713.4098
  [email protected]
• Kimberly Waggener, MD
  336.713.4098
  [email protected]

Locations (1)

Find similar trials in Winston-Salem, NC

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