Erectile Dysfunction (ED)Phase 4IPPNCT07246642
IPP Placement & Intracavernosal Block
A Phase 4 study testing Exparel/bupivacaine mixture in people with Erectile Dysfunction (ED), run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Erectile Dysfunction (ED)
- What is being tested?
- Exparel/bupivacaine mixture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient undergoing primary three-piece inflatable penile prosthesis (IPP) placement at Lexington Medical Center
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Sachin Vyas, 336-713-4098, Sachin.Vyas@Advocatehealth.org
Kimberly Waggener, MD, 336.713.4098, kimberly.waggener@advocatehealth.org
About this study
Official title: Randomized Controlled Trial of Intracorporal Local Anesthesia vs Saline Prior to Placement of Inflatable Penile Prosthesis Placement
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.
Read the detailed 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.
- Conditions
- Erectile Dysfunction (ED)
- Being tested
- Exparel/bupivacaine mixture
- Keywords
- inflatable penile prosthesis (IPP), Pain management, Penile pain
- Medical subject headings
- Erectile Dysfunction, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exparel/bupivacaine mixtureDrug
Also called Exparel (133 mg, 1.3%) with 10cc of 0.5% standard bupivacaine (50 mg)
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Exparel/bupivacaine mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Hour 24
Secondary outcomes (6)
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.
Measured: Day 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
Measured: Day 30
Number of Complications
Complications from intracavernosal injections
Measured: Day 30
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
Measured: Day 30
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
Measured: Hours 1 and 24
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.
Measured: Hour 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction (ED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Terlecki, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246642
- Sponsor's protocol ID
- IRB00129597
- Acronym
- IPP
- Status last verified
- Sep 2026
- First submitted
- 17 Nov 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the Individual participant data collected during the trial, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Intracorporal Local Anesthesia vs Saline Prior to Placement of Inflatable Penile Prosthesis Placement
- ClinicalTrials.gov ID
- NCT07246642
- Acronym / sponsor ID
- IPP / IRB00129597
- Conditions
- Erectile Dysfunction (ED)
- Keywords
- inflatable penile prosthesis (IPP), Pain management, Penile pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Exparel/bupivacaine mixture10cc Exparel/bupivacaine mixture will be injected into each corporal body (left and right for a total of 20cc) |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient undergoing primary three-piece inflatable penile prosthesis (IPP) placement at Lexington Medical Center
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exparel/bupivacaine mixtureAlso: Exparel (133 mg, 1.3%) with 10cc of 0.5% standard bupivacaine (50 mg)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. | Drug | Exparel/bupivacaine mixture Arm |
Primary outcome
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.
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.
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.
6 secondary outcomes
Cumulative Morphine milligram equivalents (MME)
Time frame: Day 2
Number of calls, messages, or visits to clinic
Time frame: Day 30
Number of Complications
Time frame: Day 30
Number of Other Complications
Time frame: Day 30
Serum bupivacaine levels
Time frame: Hours 1 and 24
Amount of tramadol usage
Time frame: Hour 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Yes. All of the Individual participant data collected during the trial, after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan Terlecki, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exparel/bupivacaine mixture in people with Erectile Dysfunction (ED), run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sachin Vyas (336.713.4098, Sachin.Vyas@Advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) Scores (time frame: Hour 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.