IPP Placement & Intracavernosal Block

NCT07246642 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB00129597
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erectile Dysfunction (ED)

Keywords

inflatable penile prosthesis (IPP); Pain management; Penile pain

Outcome Measures

Primary Outcomes (3)

• Visual Analogue Scale (VAS) Scores

  VAS scores range from 0 to 100, with 0 representing no pain or the least desirable state and 100 representing the worst possible pain or the most desirable state. The "score" is the distance in millimeters from the "no pain" end of the 100mm line to the point where the person marks their pain level. Lower scores (0-4mm) indicate no pain, while higher scores (75-100mm) indicate severe pain.

  Hour 1

• Visual Analogue Scale (VAS) Scores

  VAS scores range from 0 to 100, with 0 representing no pain or the least desirable state and 100 representing the worst possible pain or the most desirable state. The "score" is the distance in millimeters from the "no pain" end of the 100mm line to the point where the person marks their pain level. Lower scores (0-4mm) indicate no pain, while higher scores (75-100mm) indicate severe pain.

  Hour 4

• Visual Analogue Scale (VAS) Scores

  VAS scores range from 0 to 100, with 0 representing no pain or the least desirable state and 100 representing the worst possible pain or the most desirable state. The "score" is the distance in millimeters from the "no pain" end of the 100mm line to the point where the person marks their pain level. Lower scores (0-4mm) indicate no pain, while higher scores (75-100mm) indicate severe pain.

  Hour 24

Secondary Outcomes (6)

• Cumulative Morphine milligram equivalents (MME)

  Day 2

• Number of calls, messages, or visits to clinic

  Day 30

• Number of Complications

  Day 30

• Number of Other Complications

  Day 30

• Serum bupivacaine levels

  Hours 1 and 24

Study Arms (2)

Control Saline Arm

NO INTERVENTION

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

Exparel/bupivacaine mixture Arm

EXPERIMENTAL

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

Drug: Exparel/bupivacaine mixture

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.

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

Exparel/bupivacaine mixture Arm

Eligibility Criteria

• Age: 21 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient undergoing primary three-piece inflatable penile prosthesis (IPP) placement at Lexington Medical Center

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction; Agnosia

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ryan Terlecki, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sachin Vyas

CONTACT

336.713.4098; Sachin.Vyas@Advocatehealth.org

Kimberly Waggener, MD

CONTACT

336.713.4098; kimberly.waggener@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double blinding - the patients and the interviewing individuals
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 26, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication - no end date
• Access Criteria: anyone who wishes to access the data

Locations

US (1)