Back to resultsA Study to Analyze the Effects of Exparel for Post-Surgery Pain Control in Patients Undergoing Penile Prosthesis Placement
Primary Purpose
Erectile Dysfunction
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Randomization of two local anesthetics.
Sponsored by
About this trial
This is an interventional basic science trial for Erectile Dysfunction
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Receiving Ropivacaine
Receiving Liposomal Bupivacaine
Arm Description
Patients receiving Ropivacaine.
Patients receiving Liposomal Bupivacaine.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04801368
Brief Title
A Study to Analyze the Effects of Exparel for Post-Surgery Pain Control in Patients Undergoing Penile Prosthesis Placement
Official Title
A Randomized-Controlled Trial Comparing Long-acting and Short-acting Local Anesthetics at the Time of Penile Prosthesis Placement
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
The two anesthetics being used in the study are FDA approved and used in standard practice for the procedure.
Masking
Participant
Masking Description
Patient is blind to local anesthetic being administered.
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Receiving Ropivacaine
Arm Type
Experimental
Arm Description
Patients receiving Ropivacaine.
Arm Title
Receiving Liposomal Bupivacaine
Arm Type
Experimental
Arm Description
Patients receiving Liposomal Bupivacaine.
Intervention Type
Drug
Intervention Name(s)
Randomization of two local anesthetics.
Intervention Description
Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
Primary Outcome Measure Information:
Title
Visual-analogue pain scale
Description
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.
Time Frame
post-operative day 1
Title
Visual-analogue pain scale
Description
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.
Time Frame
post-operative day 3
Title
Visual-analogue pain scale
Description
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.
Time Frame
post-operative day 7
Title
Visual-analogue pain scale
Description
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.
Time Frame
post-operative day 14
Title
Visual-analogue anxiety scale
Description
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.
Time Frame
post-operative day 1
Title
Visual-analogue anxiety scale
Description
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.
Time Frame
post-operative day 3
Title
Visual-analogue anxiety scale
Description
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.
Time Frame
post-operative day 7
Title
Visual-analogue anxiety scale
Description
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.
Time Frame
post-operative day 14
Title
State Trait Anxiety Inventory
Description
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.
Time Frame
post-operative day 1
Title
State Trait Anxiety Inventory
Description
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.
Time Frame
post-operative day 3
Title
State Trait Anxiety Inventory
Description
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.
Time Frame
post-operative day 7
Title
State Trait Anxiety Inventory
Description
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.
Time Frame
post-operative day 14
Title
Pain Catastrophizing scale
Description
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.
Time Frame
post-operative day 1
Title
Pain Catastrophizing scale
Description
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.
Time Frame
post-operative day 3
Title
Pain Catastrophizing scale
Description
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.
Time Frame
post-operative day 7
Title
Pain Catastrophizing scale
Description
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.
Time Frame
post-operative day 14
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew J Ziegelmann, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study to Analyze the Effects of Exparel for Post-Surgery Pain Control in Patients Undergoing Penile Prosthesis Placement
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