Perioperative Pregabalin in Ureteroscopy: a Pilot

Phase 3

Completed

• Conditions: Urolithiasis; Anesthesia; Nephrolithiasis; Pain, Postoperative; Pain, Acute; Anesthesia Morbidity; Perioperative/Postoperative Complications; Urologic Diseases
• Interventions: Drug: Pregabalin 300mg

• Registration Number: NCT03927781
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-04-22
• Study First Posted: 2019-04-25
• Primary Completion: 2019-10-17
• Study Completion: 2020-10-17
• Results First Submitted: 2021-02-27
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-16
• Last Update Submitted: 2021-04-16
• Results First Posted: 2021-04-19
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pregabalin 300mg	Pregabalin 300mg	300mg pregabalin, PO, once, 1 hr before surgery

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Were Administered the Study Drug Correctly	Day of surgery
Number of Participants With One or More Adverse Events Related to Study Drug	Day of surgery
Respondent Reported Usability of Instruments	30 days post-op	Number of patients able to complete 30 day post op questionnaire

Secondary Outcome Measures

Name	Time	Method
Opioid Use	Up to 1 year post-op	Number of patients stating that they had used opioids on any survey.
Unplanned Healthcare Contacts	First 30 post-operative days	Number of unplanned contacts between the patient and the healthcare system. This is the total for all patients.
Amount of Opioid Use	Up to 1 year post-op	Total amount of opioid used for any indication at several time points, in oral morphine equivalents. This is the sum for all patients.
Early Post-op Stent Related Symptoms	Post-op day 3	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.
Early Post-op Opioid Needs	First 30 post-operative days	Number of patients with a verified prescription for narcotic medication within the first 30 post-operative days.
Patient Satisfaction	First 30 post-operative days	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.

Trial Locations

Locations (1)

University of Missouri-Columbia; 🇺🇸 Columbia, Missouri, United States