Clinical trial NCT04801368: Randomized Trial of Ropivacaine & Bupivacaine for Inflatable Penile Prosthesis
Official title: A Randomized-Controlled Trial Comparing Long-acting and Short-acting Local Anesthetics at the Time of Penile Prosthesis Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The two anesthetics being used in the study are FDA approved and used in standard practice for the procedure. Subjects will be blindly assigned to one of two study groups at the initial phase of the study.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual-analogue Pain Scale
timeFrame: post-operative day 3
measure: Visual-analogue Pain Scale
timeFrame: post-operative day 7
measure: Visual-analogue Pain Scale
timeFrame: post-operative day 14
measure: Visual-analogue Anxiety Scale
timeFrame: post-operative day 3
measure: Visual-analogue Anxiety Scale
timeFrame: post-operative day 7
measure: Visual-analogue Anxiety Scale
timeFrame: post-operative day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew J Ziegelmann, MD
role: PRINCIPAL_INVESTIGATOR
References: