IPP Placement & Intracavernosal Block

Recruitment Status
NOT YET RECRUITING
(See Contacts and Locations)Verified August 2025 by Wake Forest University Health Sciences
Sponsor
Wake Forest University Health Sciences
Information Provided by (Responsible Party)
Wake Forest University Health Sciences
Clinicaltrials.gov Identifier
NCT07246642
Other Study ID Numbers:
IRB00129597
First Submitted
November 16, 2025
First Posted
November 23, 2025
Last Update Posted
March 30, 2026
Last Verified
August 2025

ClinicalTrials.gov processed this data on March 2026Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

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.

Condition or DiseaseIntervention/Treatment
Erectile Dysfunction (ED)
Drug: Exparel/bupivacaine mixture

Study Design

Study TypeInterventional
Actual Enrollment100 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleRandomized Controlled Trial of Intracorporal Local Anesthesia vs Saline Prior to Placement of Inflatable Penile Prosthesis Placement
Study Start DateApril 30, 2026
Actual Primary Completion Date1yr 3mos from now
Actual Study Completion Date1yr 4mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Control Saline Arm
10cc of normal saline will be injected into each corporal body (left and right for a total of 20cc)
Exparel/bupivacaine mixture Arm
10cc Exparel/bupivacaine mixture will be injected into each corporal body (left and right for a total of 20cc)
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.

Outcome Measures

Primary Outcome Measures
  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.
  2. 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.
  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.
Secondary Outcome Measures
  1. Cumulative Morphine milligram equivalents (MME)
    Cumulative morphine milligram equivalent (MME) is a metric used by healthcare providers to standardize the total potency of all opioid medications a patient is taking. By converting each opioid into a standard value based on morphine, providers can assess a patient's overall risk for overdose and other complications. Higher cumulative MME levels are associated with a greater risk of overdose. For example, doses of 50 MME or more per day increase overdose risk and warrant closer monitoring, while doses of 90 MME or more are considered very high.
  2. Number of calls, messages, or visits to clinic
    Physician access line calls, messages to clinic, visits to clinic for postoperative pain within 30 days after surgery
  3. Number of Complications
    Complications from intracavernosal injections
  4. Number of Other Complications
    Other complications after IPP surgery using the Clavien-Dindo grading scale - The Clavien-Dindo scale is a grading system that categorizes surgical complications based on the treatment required to manage them, providing a uniform and objective way to assess and report post-operative events. It consists of five grades, with Grade I being minor deviations not requiring intervention and Grade V indicating patient death
  5. Serum bupivacaine levels
    Serum bupivacaine levels at 1 hour and 1 day after surgery - Serum bupivacaine levels are a measurement of the drug in the blood, and the "normal" or safe level varies significantly by the patient's condition, the administration site, and the dose - A 1-mL serum or plasma sample is typically collected in a red-top or green-top tube
  6. Amount of tramadol usage
    Use the lowest dose possible for the shortest time needed. Take your prescribed dose as indicated by your healthcare provider. The maximum dosage is 1 or 2 tablets every 4 to 6 hours, as needed for pain relief.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyMale
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsWake Forest University Health Sciences
Locations
Wake Forest University Health Sciences | Winston-Salem North Carolina, United States, 27157
Investigators
Principal Investigator: Ryan Terlecki, MD, Wake Forest University Health Sciences