Randomized Controlled Trial of Intracorporal Local Anesthesia vs Saline Prior to Placement of Inflatable Penile Prosthesis Placement
Wake Forest University Health Sciences
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.
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.
Eligibility
- Age range
- 21+ years
- Sex
- Male
- Healthy volunteers
- No
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
Interventions
- DrugExparel/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.
Location
- Wake Forest University Health SciencesWinston-Salem, North Carolina