NCT04801368 - Randomized Trial of Ropivacaine & Bupivacaine for Inflatable Penile Prosthesis | Crick

Overview

The purpose of this research is to determine the effects of penile ring block for local anesthesia with liposomal bupivacaine vs ropivacaine mixture in subjects undergoing surgery for Penile Prosthesis Placement.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

20

Conditions

Erectile Dysfunction

Interventions

Randomization of two local anesthetics.DRUG

Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Men undergoing 3-piece penile prosthesis placement under general anesthesia at Mayo Clinic - Rochester. * ≥ 18 years old. Exclusion Criteria: * History of opioid exposure within the preceding 90 days prior to surgery (based on patient-report, review of the electronic medical record, and NMP prescribing database review) * Current or prior history of alcohol or drug abuse (illicit or prescription) * History of chronic pain conditions (chronic musculoskeletal pain, fibromyalgia, central sensitization, chronic pelvic pain syndrome, etc.) * History of cardiac arrhythmia or untreated severe cardiovascular disease * Uncontrolled hypertension * Hepatic insufficiency * Renal insufficiency (CKD stage IIIa or greater) * Current anti-platelet or anti-coagulation therapy with plans to continue at the time of prosthesis placement * Poorly controlled diabetes mellitus (defined as HgbA1c \> 8.5 within 30 days of surgery) * Concurrent adjunctive operative procedures planned at the time of penile prosthesis placement (examples: male urethral sling, Peyronie's disease straightening with penile plication or incision/grafting) * Concurrent non-prosthetic surgery planned at the time of penile prosthesis placement (examples: circumcision, hernia repair, hydrocelectomy, etc.) * Planned infrapubic or subcoronal incision at the time of penile prosthesis placement * Patients who will be undergoing prosthesis placement using local, monitored, or spinal anesthesia (i.e. non-general anesthesia) * Allergy or history of intolerance to any local anesthetic agents included in the protocol * History of prior penile prosthesis or artificial urinary sphincter surgery * Revision penile prosthesis surgery

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Visual-analogue Pain Scale

Visual-analogue pain scale is a tool used to measure pain intensity at a specific timepoint, asking a patient to use visuals to rate their pain on a scale of 1 to 10. Results are reported as units on a scale, minimum 1 (experiencing the least amount of pain possible) to maximum of 10 (experiencing an unbearably high amount of pain). Lower scores provide a better outcome for the patient as they are experiencing less pain post-operatively.

Time frame: post-operative day 3

Visual-analogue Pain Scale

Visual-analogue pain scale is a tool used to measure pain intensity at a specific timepoint, asking a patient to use visuals to rate their pain on a scale of 1 to 10. Results are reported as units on a scale, minimum 1 (experiencing the least amount of pain possible) to maximum of 10 (experiencing an unbearably high amount of pain). Lower scores provide a better outcome for the patient as they are experiencing less pain post-operatively.

Time frame: post-operative day 7

Visual-analogue Pain Scale

Visual-analogue pain scale is a tool used to measure pain intensity at a specific timepoint, asking a patient to use visuals to rate their pain on a scale of 1 to 10. Results are reported as units on a scale, minimum 1 (experiencing the least amount of pain possible) to maximum of 10 (experiencing an unbearably high amount of pain). Lower scores provide a better outcome for the patient as they are experiencing less pain post-operatively.

Time frame: post-operative day 14

Visual-analogue Anxiety Scale

Visual-analogue anxiety scale is a tool used to measure anxiety intensity at a specific timepoint, asking a patient to use visuals to rate their current anxiety on a scale of 1 to 10. Results are reported as units on a scale, minimum 1 (experiencing the least amount of anxiety possible) to maximum of 10 (experiencing an unbearably high amount of anxiety). Lower scores provide a better outcome for the patient as they are experiencing less anxiety post-operatively.

Time frame: post-operative day 3