A Study to Analyze the Effects of Exparel for Post-Surgery Pain Control in Patients Undergoing Penile Prosthesis Placement

Erectile Dysfunction Clinical Trial

Official title:

A Randomized-Controlled Trial Comparing Long-acting and Short-acting Local Anesthetics at the Time of Penile Prosthesis Placement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04801368
• Other study ID #: 20-010842
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2021
• Est. completion date: January 8, 2024

Study information

• Verified date: January 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 8, 2024
• Est. primary completion date: January 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men undergoing 3-piece penile prosthesis placement under general anesthesia at Mayo Clinic - Rochester.
• = 18 years old.

Exclusion Citeria:

• 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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Randomization of two local anesthetics.
Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual-analogue pain scale	Patients will answer this questionnaire at 4 separate time points. Scale of 1-10, 0 being no pain, 10 being the most pain. 0 being the best outcome, 10 being the worst outcome.	post-operative day 1
Primary	Visual-analogue pain scale	Patients will answer this questionnaire at 4 separate time points. Scale of 1-10, 0 being no pain, 10 being the most pain. 0 being the best outcome, 10 being the worst outcome.	post-operative day 3
Primary	Visual-analogue pain scale	Patients will answer this questionnaire at 4 separate time points. Scale of 1-10, 0 being no pain, 10 being the most pain. 0 being the best outcome, 10 being the worst outcome.	post-operative day 7
Primary	Visual-analogue pain scale	Patients will answer this questionnaire at 4 separate time points. Scale of 1-10, 0 being no pain, 10 being the most pain. 0 being the best outcome, 10 being the worst outcome.	post-operative day 14
Primary	Visual-analogue anxiety scale	Patients will answer this questionnaire at 4 separate time points. Scale of 1-10, 0 being no anxiety, 10 being the most anxiety. 0 being the best outcome, 10 being the worst outcome.	post-operative day 1
Primary	Visual-analogue anxiety scale	Patients will answer this questionnaire at 4 separate time points. Scale of 1-10, 0 being no anxiety, 10 being the most anxiety. 0 being the best outcome, 10 being the worst outcome.	post-operative day 3
Primary	Visual-analogue anxiety scale	Patients will answer this questionnaire at 4 separate time points. Scale of 1-10, 0 being no anxiety, 10 being the most anxiety. 0 being the best outcome, 10 being the worst outcome.	post-operative day 7
Primary	Visual-analogue anxiety scale	Patients will answer this questionnaire at 4 separate time points. Scale of 1-10, 0 being no anxiety, 10 being the most anxiety. 0 being the best outcome, 10 being the worst outcome.	post-operative day 14
Primary	State Trait Anxiety Inventory	Patients will answer this questionnaire at 4 separate time points. Scale of 1-4 answering 20 questions. 1 being not at all, 2 being a little, 3 being somewhat, 4 being very much so. Best outcome varies with each question.	post-operative day 1
Primary	State Trait Anxiety Inventory	Patients will answer this questionnaire at 4 separate time points. Scale of 1-4 answering 20 questions. 1 being not at all, 2 being a little, 3 being somewhat, 4 being very much so. Best outcome varies with each question.	post-operative day 3
Primary	State Trait Anxiety Inventory	Patients will answer this questionnaire at 4 separate time points. Scale of 1-4 answering 20 questions. 1 being not at all, 2 being a little, 3 being somewhat, 4 being very much so. Best outcome varies with each question.	post-operative day 7
Primary	State Trait Anxiety Inventory	Patients will answer this questionnaire at 4 separate time points. Scale of 1-4 answering 20 questions. 1 being not at all, 2 being a little, 3 being somewhat, 4 being very much so. Best outcome varies with each question.	post-operative day 14
Primary	Pain Catastrophizing scale	Patients will answer this questionnaire at 4 separate time points. Scale of 0-4 answering 20 questions. 0 being not at all, 1 being to a slight degree, 2 being to a moderate degree, 3 being to a great degree, 4 being all the time. Best outcome varies with each question.	post-operative day 1
Primary	Pain Catastrophizing scale	Patients will answer this questionnaire at 4 separate time points. Scale of 0-4 answering 20 questions. 0 being not at all, 1 being to a slight degree, 2 being to a moderate degree, 3 being to a great degree, 4 being all the time. Best outcome varies with each question.	post-operative day 3
Primary	Pain Catastrophizing scale	Patients will answer this questionnaire at 4 separate time points. Scale of 0-4 answering 20 questions. 0 being not at all, 1 being to a slight degree, 2 being to a moderate degree, 3 being to a great degree, 4 being all the time. Best outcome varies with each question.	post-operative day 7
Primary	Pain Catastrophizing scale	Patients will answer this questionnaire at 4 separate time points. Scale of 0-4 answering 20 questions. 0 being not at all, 1 being to a slight degree, 2 being to a moderate degree, 3 being to a great degree, 4 being all the time. Best outcome varies with each question.	post-operative day 14

External Links

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