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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receiving Ropivacaine | Experimental | Patients receiving Ropivacaine. |
|
| Receiving Liposomal Bupivacaine | Experimental | Patients receiving Liposomal Bupivacaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Randomization of two local anesthetics. | Drug | Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J Ziegelmann, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Receiving Ropivacaine | Patients receiving Ropivacaine intra-operatively. Randomization of two local anesthetics.: Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine. Dosage depends on subjects height, weight, and other health factors |
| FG001 | Receiving Liposomal Bupivacaine | Patients receiving Liposomal Bupivacaine intra-operatively. Randomization of two local anesthetics.: Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine. Dosage depends on subjects height, weight, and other health factors |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Receiving Liposomal Bupivacaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | units on a scale | post-operative day 3 |
|
1 YEARS, 3 MONTHS
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew Ziegelmann | Mayo Clinic | 507-266-3982 | Ziegelmann.Matthew@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2021 | Nov 27, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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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.
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Patient is blind to local anesthetic being administered.
| post-operative day 3 |
| 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. | post-operative day 7 |
| 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. | post-operative day 14 |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| State Trait Anxiety Inventory | The State-Trait Anxiety Inventory (STAI) is a survey that measures a person's tendency to experience anxiety when faced with stress. Results are reported as units on a scale, minimum 20 (scoring low on a tendency to experience anxiety when faced with stress) to maximum of 80 (scoring high on a tendency to experience anxiety when faced with stress). Results may impact a subject's tendency to score higher on later measures, hence why this scale is used at a baseline visit. | Mean | Standard Deviation | units on a scale |
|
| Pain Catastrophizing Scale | The Pain Catastrophizing Scale is a questionnaire that measures how much someone catastrophizes about pain. Results are reported as units on a scale, minimum 0 (scoring low on a tendency to catastrophize pain, or rate pain as more tolerable than other people) to maximum of 52 (scoring high on a tendency to catastrophize pain, or rate pain as less tolerable than other people). Results may impact a subject's tendency to score higher on later pain measures, hence why this scale is used at a baseline visit. | Mean | Standard Deviation | units on a scale |
|
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. |
|
|
| 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. | Posted | Mean | Full Range | units on a scale | post-operative day 7 |
|
|
|
| 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. | Posted | Mean | Full Range | units on a scale | post-operative day 14 |
|
|
|
| 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. | Posted | Mean | Full Range | units on a scale | post-operative day 3 |
|
|
|
| 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. | Posted | Mean | Full Range | units on a scale | post-operative day 7 |
|
|
|
| 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. | Posted | Mean | Full Range | units on a scale | post-operative day 14 |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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. | 0 | 14 | 0 | 14 | 0 | 14 |
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| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |