About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Any patient undergoing primary three-piece inflatable penile prosthesis (IPP) placement at Lexington Medical Center

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Control Saline ArmNo intervention 0 interventions

Group B: Exparel/bupivacaine mixture ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Hour 1

2

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.

Time frame

Hour 4

3

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.

Time frame

Hour 24

Secondary outcomes

1

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.

Time frame

Day 2

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

Time frame

Day 30

3

Number of Complications

Complications from intracavernosal injections

Time frame

Day 30

4

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

Time frame

Day 30

IPP Placement & Intracavernosal Block

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts