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The investigators propose a pilot clinical trial on the use of perioperative pregabalin in order to decrease ureteral stent related symptoms and decrease opioid usage after ureteroscopy with stent placement. Patients undergoing ureteroscopy with stent placement will receive a single dose of 300 mg pregabalin PO in the preoperative area. This work will assess safety and feasibility of studying this regimen at our institution, with the aim of performing a randomized, placebo-controlled, double-blinded study in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin 300mg | Experimental | 300mg pregabalin, PO, once, 1 hr before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin 300mg | Drug | One 300mg capsule will be administered PO 1 hour before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Adverse Events Related to Study Drug | Day of surgery | |
| Number of Participants Who Were Administered the Study Drug Correctly | Day of surgery | |
| Respondent Reported Usability of Instruments | Number of patients able to complete 30 day post op questionnaire | 30 days post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Early Post-op Stent Related Symptoms | Ureteral Stent Related Symptom Questionnaire (USSQ) score, sum of urinary index score, pain index score, and general health index score. Minimum is 24. Maximum is 162. Higher scores indicate a worse outcome. | Post-op day 3 |
| Early Post-op Opioid Needs |
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Subject Population Undergoing elective ureteroscopy with stent placement by Dr. Murray at University of Missouri Hospital and affiliated facilities
Subject Inclusion
Age >= 18 years
Subject Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Katie Murray, DO | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri-Columbia | Columbia | Missouri | 65212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin 300mg | 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin 300mg | 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery |
| 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 | Number of Participants With One or More Adverse Events Related to Study Drug | Posted | Count of Participants | Participants | Day of surgery |
|
|
Events were systematically characterized on the day of surgery. Adverse events were otherwise by report up to 30 days after the patient's procedure.
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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 | Pregabalin 300mg | 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Katie Murray | University of Missouri | 573-884-8768 | murraykat@health.missouri.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Mar 13, 2019 | Nov 21, 2019 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 20, 2019 | Nov 21, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D052878 | Urolithiasis |
| D011183 | Postoperative Complications |
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| D014570 | Urologic Diseases |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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All participants will receive 300mg PO pregabalin one hour before procedure start
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There will be no blinding for this pilot
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Number of patients with a verified prescription for narcotic medication within the first 30 post-operative days. |
| First 30 post-operative days |
| Opioid Use | Number of patients stating that they had used opioids on any survey. | Up to 1 year post-op |
| Amount of Opioid Use | Total amount of opioid used for any indication at several time points, in oral morphine equivalents. This is the sum for all patients. | Up to 1 year post-op |
| Unplanned Healthcare Contacts | Number of unplanned contacts between the patient and the healthcare system. This is the total for all patients. | First 30 post-operative days |
| Patient Satisfaction | Score on standardized evaluation of patient satisfaction at 7-days post-op. This was on a scale from 1) very dissatisfied to 5) very satisfied. Higher scores are better. | First 30 post-operative days |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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| Primary | Number of Participants Who Were Administered the Study Drug Correctly | Posted | Count of Participants | Participants | Day of surgery |
|
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| Primary | Respondent Reported Usability of Instruments | Number of patients able to complete 30 day post op questionnaire | Posted | Count of Participants | Participants | 30 days post-op |
|
|
|
| Secondary | Early Post-op Stent Related Symptoms | Ureteral Stent Related Symptom Questionnaire (USSQ) score, sum of urinary index score, pain index score, and general health index score. Minimum is 24. Maximum is 162. Higher scores indicate a worse outcome. | Those who completed the questionnaire | Posted | Mean | Full Range | score on a scale | Post-op day 3 |
|
|
|
| Secondary | Early Post-op Opioid Needs | Number of patients with a verified prescription for narcotic medication within the first 30 post-operative days. | Posted | Count of Participants | Participants | First 30 post-operative days |
|
|
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| Secondary | Opioid Use | Number of patients stating that they had used opioids on any survey. | Posted | Count of Participants | Participants | Up to 1 year post-op |
|
|
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| Secondary | Amount of Opioid Use | Total amount of opioid used for any indication at several time points, in oral morphine equivalents. This is the sum for all patients. | Posted | Number | oral morphine equivalents | Up to 1 year post-op |
|
|
|
| Secondary | Unplanned Healthcare Contacts | Number of unplanned contacts between the patient and the healthcare system. This is the total for all patients. | Posted | Number | visits | First 30 post-operative days |
|
|
|
| Secondary | Patient Satisfaction | Score on standardized evaluation of patient satisfaction at 7-days post-op. This was on a scale from 1) very dissatisfied to 5) very satisfied. Higher scores are better. | Respondents to the survey | Posted | Mean | Full Range | score on a scale | First 30 post-operative days |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 6 |
| 10 |
| Increased appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Back pain | Nervous system disorders | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | Nervous system disorders | Systematic Assessment |
|
| Confusion | Nervous system disorders | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Blurred vision | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
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| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |