Perioperative Pregabalin in Ureteroscopy: a Pilot

Study Overview
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Brief Summary
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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.

Official Title
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Perioperative Pregabalin as Part of a Multimodal Treatment Plan for Pain After Ureteroscopy With Stent Placement: a Pilot

Conditions
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Nephrolithiasis, Urolithiasis, Perioperative/Postoperative Complications, Pain, Postoperative, Pain, Acute, Anesthesia, Urologic Diseases, Anesthesia Morbidity

Intervention / Treatment
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* Drug: Pregabalin 300mg


Participation Criteria
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Eligibility Criteria
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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 Renal insufficiency (eGFR < 30 mL/minute/1.73 m2) Chronic indwelling ureteral stent Chronic opioid use History of opioid abuse Chronic gabapentinoid use Plan for inpatient hospitalization Pregnancy Inability of the patient to consent for themselves in English Allergy to gabapentinoid Liver failure or hepatic dysfunction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will receive 300mg PO pregabalin one hour before procedure start
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregabalin 300mg<br>300mg pregabalin, PO, once, 1 hr before surgery | Drug: Pregabalin 300mg<br>* One 300mg capsule will be administered PO 1 hour before surgery<br>* Other names: Gabapentinoid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregabalin, Perioperative medicine, Opioid sparing, Urolithiasis, Ureteroscopy