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The use of non-narcotic multi-modal analgesia to be used in the pre-operative, peri-operative and post-operative period to reduce or potentially eliminate narcotic usage following scrotal surgery. Research study results have shown that the use of anti-inflammatories in the peri-operative period reduces both pain and narcotic use. The hypothesis is that adding another agent in the multi-modal pathway will further reduce pain and potentially reduce narcotic usage.
This is a double-blinded, placebo-controlled, randomized trial that will recruit patients categorized into two study arms. Patients in the gabapentin arm will receive gabapentin 600mg taken pre-operatively and 300mg taken three times a day for 3 days, while patients in the placebo arm will receive a placebo drug taken pre-operatively three times a day for 3 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin | Experimental | Participants receive Gabapentin 600mg tablet taken pre-operatively and 300mg taken three times a day for 3 days. |
|
| Placebo | Placebo Comparator | Participants receive Placebo tablet taken pre-operatively and three times a day for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | Gabapentin 600mg tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score as Measured by the NRS-11 Scale | The Numerical pain Rating Scale (NRS-11) is an 11-point numerical pain rating scale used to measure levels of pain. The lowest possible score is 0 with 0 meaning no pain, and the highest possible score is 10 with 10 meaning severe pain. | Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption, as Measured by Number of Tablets Taken. | Participants were requested to self-report the number of opioid tablets (oxycodone, 5mg) that they had taken since the last survey. | Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7 |
| Change in Narcotic Consumption, as Measured by Frequency of Narcotic Tablets Taken |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Gal, M.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38382042 | Derived | Punjani N, Marinaro JA, Kang C, Gal J, Rippon B, Jotwani R, Weinberg R, Schlegel PN. Gabapentin for Postoperative Pain Control and Opioid Reduction in Scrotal Surgery: A Randomized Controlled Clinical Trial. J Urol. 2024 May;211(5):658-666. doi: 10.1097/JU.0000000000003884. Epub 2024 Feb 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gabapentin | Participants receive Gabapentin 600mg tablet taken pre-operatively and 300mg taken three times a day for 3 days. Gabapentin: Gabapentin 600mg tablet |
| FG001 | Placebo | Participants receive Placebo tablet taken pre-operatively and three times a day for 3 days Placebo: Placebo tablet |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
1 subject on the gabapentin arm and 3 subjects on the placebo arm were excluded as data collected from these participants was insufficient for analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Gabapentin | Participants receive Gabapentin 600mg tablet taken pre-operatively and 300mg taken three times a day for 3 days. Gabapentin: Gabapentin 600mg tablet |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Pain Score as Measured by the NRS-11 Scale | The Numerical pain Rating Scale (NRS-11) is an 11-point numerical pain rating scale used to measure levels of pain. The lowest possible score is 0 with 0 meaning no pain, and the highest possible score is 10 with 10 meaning severe pain. | 1 subject has been lost to followup in the gabapentin arm and was therefore excluded from analysis. 2 subjects have been lost to followup in the placebo arm and were therefore excluded from analysis. 1 subject experienced an adverse event in the placebo arm and was taken off the study medication and was therefore excluded from analysis. | Posted | Mean | Standard Deviation | scores on a scale | Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7 |
|
After surgery (post-operative day 0) through 2 weeks post-operatively.
Adverse events were self-reported by participants from the day of surgery (post-operative day 0) through post-operative day 7, along with pain score and number of opioid tablets taken. Participants were also evaluated and assessed for adverse events 2-weeks post-operatively by the surgeon.
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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 | Gabapentin | Participants receive Gabapentin 600mg tablet taken pre-operatively and 300mg taken three times a day for 3 days. Gabapentin: Gabapentin 600mg tablet |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| syncopal episode | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI upset (abdominal pain, bloating, heartburn) | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grace Tan, Clinical Research Coordinator | Weill Cornell Medical College | 212-746-3208 | grt2008@med.cornell.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 | Apr 20, 2023 | Aug 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Drug |
Placebo tablet |
|
Frequency of narcotic tablets that were taken after surgery |
| Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7 |
| Change in Narcotic Consumption, as Measured by Duration of Narcotic Tablets Consumption | Duration (time period) over which narcotic tablets that were consumed | Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7 |
Participants receive Placebo tablet taken pre-operatively and three times a day for 3 days
Placebo: Placebo tablet
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Participants receive Placebo tablet taken pre-operatively and three times a day for 3 days Placebo: Placebo tablet |
|
|
|
| Secondary | Opioid Consumption, as Measured by Number of Tablets Taken. | Participants were requested to self-report the number of opioid tablets (oxycodone, 5mg) that they had taken since the last survey. | 1 subject has been lost to followup in the gabapentin arm and was therefore excluded from analysis. 2 subjects have been lost to followup in the placebo arm and were therefore excluded from analysis. 1 subject experienced an adverse event in the placebo arm and was taken off the study medication and was therefore excluded from analysis. | Posted | Mean | Standard Deviation | Number of oxycodone 5mg tablets consumed | Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7 |
|
|
|
|
| Secondary | Change in Narcotic Consumption, as Measured by Frequency of Narcotic Tablets Taken | Frequency of narcotic tablets that were taken after surgery | Data was not collected for this measure. | Posted | Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7 |
|
|
| Secondary | Change in Narcotic Consumption, as Measured by Duration of Narcotic Tablets Consumption | Duration (time period) over which narcotic tablets that were consumed | Data was not collected for this measure. | Posted | Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7 |
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 16 |
| 36 |
| EG001 | Placebo | Participants receive Placebo tablet taken pre-operatively and three times a day for 3 days Placebo: Placebo tablet | 0 | 38 | 2 | 38 | 15 | 38 |
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
|
| Blurry vision | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | General disorders | Non-systematic Assessment |
|
| Lightheadedness | General disorders | Non-systematic Assessment |
|
| Somnolence, drowsiness | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Insomnia | General disorders | Non-systematic Assessment |
|
| Hot flashes | General disorders | Non-systematic Assessment |
|
| Weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Chest tightness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| Post-Operative Day 1, before noon |
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| Post-Operative Day 1, after noon |
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| Post-Operative Day 2, midnight |
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| Post-Operative Day 2, before noon |
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| Post-Operative Day 2, after noon |
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| Post-Operative Day 3, before noon |
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| Post-Operative Day 3, after noon |
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| Post-Operative Day 4, before noon |
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| Post-Operative Day 4, after noon |
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| Post-Operative Day 5, before noon |
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| Post-Operative Day 5, after noon |
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| Post-Operative Day 6, before noon |
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| Post-Operative Day 6, after noon |
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| Post-Operative Day 7, before noon |
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| Post-Operative Day 7, after noon |
|