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IPP Placement & Intracavernosal Block

NCT ID: NCT07246642

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-08-31

Brief Summary

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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.

Detailed Description

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It would be ideal to create an effective and easily reproducible approach to pain prevention and pain management in men undergoing IPP placement. One highly appealing target would be intracavernosal administration, as there would be no ambiguity regarding delivery of agent at the time of surgery. Thus far, no prospective randomized controlled trials have explored the efficacy of intracavernosal administration of local anesthetic for pain management.

Conditions

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Erectile Dysfunction (ED)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized at the time of surgery into one of two groupings: 1-10cc saline injection into each corpora for a total of 20cc immediately prior to placement of corporotomy stay sutures or 2- a 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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
double blinding - the patients and the interviewing individuals

Study Groups

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Control Saline Arm

10cc of normal saline will be injected into each corporal body (left and right for a total of 20cc)

Group Type NO_INTERVENTION

No interventions assigned to this group

Exparel/bupivacaine mixture Arm

10cc Exparel/bupivacaine mixture will be injected into each corporal body (left and right for a total of 20cc)

Group Type EXPERIMENTAL

Exparel/bupivacaine mixture

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Exparel (133 mg, 1.3%) with 10cc of 0.5% standard bupivacaine (50 mg)

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ryan Terlecki, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Central Contacts

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Sachin Vyas

Role: CONTACT

[email protected]
336.713.4098

Kimberly Waggener, MD

Role: CONTACT

[email protected]
336.713.4098

Facility Contacts

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Sachin Vyas

Role: primary

[email protected]
336-713-4098

Kimberly Waggener, MD

Role: backup

[email protected]
336.713.4098

Other Identifiers

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IRB00129597

Identifier Type: -

Identifier Source: org_study_id