IPP Placement & Intracavernosal Block

Wake Forest University (WFU)

Status and phase: Begins enrollment this month; Phase 4

Conditions: Erectile Dysfunction (ED)

Treatments: Drug: Exparel/bupivacaine mixture

Study type: Interventional

Funder types: Other

Identifiers

NCT07246642

IRB00129597

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Control Saline Arm

No Intervention group

Description:

10cc of normal saline will be injected into each corporal body (left and right for a total of 20cc)

Exparel/bupivacaine mixture Arm

Experimental group

Description:

10cc Exparel/bupivacaine mixture will be injected into each corporal body (left and right for a total of 20cc)

Treatment:

Drug: Exparel/bupivacaine mixture