New study aims to cut opioid use after penile implant surgery
NCT ID NCT07246642
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether injecting a long-lasting numbing medicine (Exparel mixed with bupivacaine) into the penis before placing an inflatable penile implant can reduce post-surgery pain and the need for opioid painkillers. One hundred men with erectile dysfunction who are getting a first-time implant will be randomly assigned to receive either the numbing injection or a placebo (salt water). The main goal is to see if the numbing injection leads to lower pain scores and less opioid use after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Exparel (bupivacaine) mixture
- What this could lead to
- If it works, this could provide a better way to manage pain after penile implant surgery and reduce the need for opioid painkillers.
- What could go wrong
- This is a small, early-phase study (100 people) testing a pain management technique, not a cure. The numbing effect may not be significantly better than a placebo, and individual results may vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Any patient undergoing primary three-piece inflatable penile prosthesis (IPP) placement at Lexington Medical Center Exclusion Criteria: * Patients undergoing revision and/or secondary IPP placement * Patients taking prescribed narcotic medications at the time of IPP surgery * Patients undergoing concomitant Peyronie's Disease surgery (modeling, plication, grafting) at the time of IPP surgery * Patients with liver and/or renal disease
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
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