Erectile Dysfunction
Conditions
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.
Interventions
DRUGRandomization of two local anesthetics.
Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
Patient is blind to local anesthetic being administered.
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual-analogue Pain Scale | post-operative day 3 | 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. |
| Visual-analogue Anxiety Scale | post-operative day 3 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Receiving Ropivacaine Patients receiving Ropivacaine.
Randomization of two local anesthetics.: Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine. | 5 |
| Receiving Liposomal Bupivacaine Patients receiving Liposomal Bupivacaine.
Randomization of two local anesthetics.: Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine. | 14 |
| Total | 19 |
Baseline characteristics
| Characteristic | Receiving Ropivacaine | Receiving Liposomal Bupivacaine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 7 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 7 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 13 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Pain Catastrophizing Scale | 1.6 units on a scale STANDARD_DEVIATION 2.07 | 4.08 units on a scale STANDARD_DEVIATION 5.75 | 3.39 units on a scale STANDARD_DEVIATION 5.07 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 12 Participants | 17 Participants |
| Region of Enrollment United States | 5 participants | 14 participants | 19 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 14 Participants | 19 Participants |
| State Trait Anxiety Inventory | 27 units on a scale STANDARD_DEVIATION 12.96 | 30.3 units on a scale STANDARD_DEVIATION 11.24 | 29.39 units on a scale STANDARD_DEVIATION 11.44 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 14 |
| other Total, other adverse events | 0 / 5 | 0 / 14 |
| serious Total, serious adverse events | 0 / 5 | 0 / 14 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Receiving Ropivacaine | Visual-analogue Anxiety Scale | 4 units on a scale |
| Receiving Liposomal Bupivacaine | Visual-analogue Anxiety Scale | 2.43 units on a scale |
Primary
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 7
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Receiving Ropivacaine | Visual-analogue Anxiety Scale | 4 units on a scale |
| Receiving Liposomal Bupivacaine | Visual-analogue Anxiety Scale | 2.22 units on a scale |
Primary
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 14
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Receiving Ropivacaine | Visual-analogue Anxiety Scale | 2 units on a scale |
| Receiving Liposomal Bupivacaine | Visual-analogue Anxiety Scale | 2.44 units on a scale |
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Receiving Ropivacaine | Visual-analogue Pain Scale | 6 units on a scale |
| Receiving Liposomal Bupivacaine | Visual-analogue Pain Scale | 4 units on a scale |
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Receiving Ropivacaine | Visual-analogue Pain Scale | 6 units on a scale |
| Receiving Liposomal Bupivacaine | Visual-analogue Pain Scale | 4.1 units on a scale |
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Receiving Ropivacaine | Visual-analogue Pain Scale | 2.8 units on a scale |
| Receiving Liposomal Bupivacaine | Visual-analogue Pain Scale | 3.56 units on a scale |