IPP Placement & Intracavernosal Block
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exparel/bupivacaine mixture.
- Who it may be relevant to
- Registry conditions: Erectile Dysfunction (ED). Basic parameters: from 21 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Controlled Trial of Intracorporal Local Anesthesia vs Saline Prior to Placement of Inflatable Penile Prosthesis Placement
Overview
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.
Interventions
- 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.
Primary outcome measures
- Visual Analogue Scale (VAS) Scores [Time frame: Hour 1]
- Visual Analogue Scale (VAS) Scores [Time frame: Hour 4]
- Visual Analogue Scale (VAS) Scores [Time frame: Hour 24]
Secondary outcome measures (6)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Wake Forest University Health Sciences — Winston-Salem
Identifiers
NCT: NCT07246642 · IRB00129597