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NCT Number: NCT07246642

IPP Placement & Intracavernosal Block

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.

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Key information

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Visual Analogue Scale (VAS) Scores

    Time frame: Hour 1

    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

    Time frame: Hour 4

    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

    Time frame: Hour 24

    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 outcomes

  1. Cumulative Morphine milligram equivalents (MME)

    Time frame: Day 2

    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

    Time frame: Day 30

    Physician access line calls, messages to clinic, visits to clinic for postoperative pain within 30 days after surgery

  3. Number of Complications

    Time frame: Day 30

    Complications from intracavernosal injections

  4. Number of Other Complications

    Time frame: Day 30

    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

    Time frame: Hours 1 and 24

    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

    Time frame: Hour 24

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kimberly Waggener, MD

CONTACT

[email protected]

336.713.4098

Sachin Vyas

CONTACT

[email protected]

336.713.4098

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Randomized Controlled Trial of Intracorporal Local Anesthesia vs Saline Prior to Placement of Inflatable Penile Prosthesis Placement

Acronym: IPP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 24, 2025
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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