NCT03927781

Perioperative Pregabalin in Ureteroscopy: a Pilot

Completed Phase 3 Results posted Last updated 19 April 2021

What this trial tests

Phase 3 trial testing Pregabalin 300mg in Nephrolithiasis in 10 participants. Completed in 17 October 2020.

Timeline

1 April 2019

Primary endpoint
17 October 2019

17 October 2020

Quick facts

Lead sponsor	University of Missouri-Columbia
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 April 2019
Primary completion	17 October 2019
Estimated completion	17 October 2020
Sites	1 location across United States

Drugs / interventions tested

• Pregabalin 300mg — full drug profile →

Conditions studied

• Nephrolithiasis — all drugs for Nephrolithiasis →
• Urolithiasis — all drugs for Urolithiasis →
• Perioperative/Postoperative Complications — all drugs for Perioperative/Postoperative Complications →
• Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

University of Missouri-Columbia

Who can join

18 and older, any sex, with Nephrolithiasis or Urolithiasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With One or More Adverse Events Related to Study Drug Primary · Day of surgery

Group	Value	95% CI
Pregabalin 300mg	6

Number of Participants Who Were Administered the Study Drug Correctly Primary · Day of surgery

Group	Value	95% CI
Pregabalin 300mg	10

Respondent Reported Usability of Instruments Primary · 30 days post-op

Number of patients able to complete 30 day post op questionnaire

Group	Value	95% CI
Pregabalin 300mg	5

Early Post-op Stent Related Symptoms Secondary · 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.

Group	Value	95% CI
Pregabalin 300mg	88	61 – 130

Early Post-op Opioid Needs Secondary · First 30 post-operative days

Number of patients with a verified prescription for narcotic medication within the first 30 post-operative days.

Group	Value	95% CI
Pregabalin 300mg	1

Opioid Use Secondary · Up to 1 year post-op

Number of patients stating that they had used opioids on any survey.

Group	Value	95% CI
Pregabalin 300mg	1

Amount of Opioid Use Secondary · 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.

Group	Value	95% CI
Pregabalin 300mg	90

Unplanned Healthcare Contacts Secondary · First 30 post-operative days

Number of unplanned contacts between the patient and the healthcare system. This is the total for all patients.

Group	Value	95% CI
Pregabalin 300mg	2

Patient Satisfaction Secondary · 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.

Group	Value	95% CI
Pregabalin 300mg	3.5	1 – 5

Adverse events — posted to ClinicalTrials.gov

Time frame: Events were systematically characterized on the day of surgery. Adverse events were otherwise by report up to 30 days after the patient's procedure.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pregabalin 300mg

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (9 terms — click to expand)

Reaction	System	Pregabalin 300mg
Dry mouth	Gastrointestinal disorders	—
Pain	Nervous system disorders	—
Increased appetite	Gastrointestinal disorders	—
Back pain	Nervous system disorders	—
Fatigue	Nervous system disorders	—
Confusion	Nervous system disorders	—
Somnolence	Nervous system disorders	—
Blurred vision	Nervous system disorders	—
Dizziness	Nervous system disorders	—

Data from ClinicalTrials.gov NCT03927781 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.