NCT04122196

Perioperative Pregabalin in Ureteroscopy

Completed Phase 2, PHASE3 Results posted Last updated 12 November 2025

What this trial tests

Phase 2, PHASE3 trial testing Pregabalin 300mg in Kidney Stone in 118 participants. Completed in 1 July 2024.

Timeline

1 June 2020

Primary endpoint
1 July 2023

1 July 2024

Quick facts

Lead sponsor	University of Missouri-Columbia
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	118
Start date	1 June 2020
Primary completion	1 July 2023
Estimated completion	1 July 2024
Sites	1 location across United States

Drugs / interventions tested

• Pregabalin 300mg — full drug profile →
• Placebo oral tablet — full drug profile →

Conditions studied

• Kidney Stone — all drugs for Kidney Stone →
• Pain, Postoperative — all drugs for Pain, Postoperative →
• Addiction — all drugs for Addiction →
• Opioid Use — all drugs for Opioid Use →

Sponsor

University of Missouri-Columbia

Who can join

18 and older, any sex, with Kidney Stone or Pain, Postoperative. 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.

Visual Analog Scale of Pain Score Primary · 1 hour after arrival to post anesthesia care unit

This was a visual analogue scale of pain as described in Ahles et al 1984. The patients were given a paper with a 10cm horizontal line on it. On the left was marked "No pain" and on the right "Worst pain imaginable". The patients were then asked to mark a vertical line along the 10cm line that indicated where their pain was. The score is the number of centimeters from the left. 0 is minimum (best). 10 maximum (worst).

Group	Value	95% CI
Pregabalin 300mg	3.7	1.5 – 6.3
Placebo	2.0	0.6 – 4.2

Oral Morphine Equivalents of Opioids Prescribed Secondary · Within the first 30 days post-operation

Group	Value	95% CI
Pregabalin 300mg	60	13 – 90
Placebo	50	0 – 60

Proportion of Patients With Narcotic Prescription Secondary · Within the first 30 days post-operation

Group	Value	95% CI
Pregabalin 300mg	44
Placebo	35

Number of Unplanned Healthcare Interactions Secondary · Within the first 30 days post-operation

Unplanned healthcare interactions include unplanned visits, emergency room visits, admissions to the hospital, and phone calls

Group	Value	95% CI
Pregabalin 300mg	8
Placebo	16

Number of Serious Adverse Events Secondary · Within the first 30 days post-operation

Composite of unplanned serious adverse events including intensive care unit stay and death

Group	Value	95% CI
Pregabalin 300mg	0
Placebo	0

Watson Clock Drawing Test Score Secondary · 1 hour after arrival to post anesthesia care unit

This score is based on the scoring method described in Watson et al 1993. Higher scores demonstrate more errors. A clock is drawn. This is divided into quadrants. For errors in quadrants 1-3 (clock 12-8), a score of 1 is assigned. For errors in quadrant 4, a score of 4 is assigned. The scores are summed. Total scores range from 0 to 7 with 7 representing significant impairment (worst) and 0 representing no impairment (best).

Group	Value	95% CI
Pregabalin 300mg	1.8	± 2.1
Placebo	1.8	± 2.2

In-facility Oral Morphine Equivalents Secondary · Day of surgery

Group	Value	95% CI
Pregabalin 300mg	38	30 – 63
Placebo	35	30 – 48

Nausea/Vomiting in PACU Secondary · In post anesthesia care unit (usually approximately 1 hour post op)

Group	Value	95% CI
Pregabalin 300mg	2
Placebo	0

Sponsor's own description

This is a randomized, placebo-controlled, double-blinded study examining the use of perioperative pregabalin in ureteroscopy with stent placement. Ureteroscopy is typically performed for kidney or ureteral stones, but may be performed for other reasons such as for the diagnosis and possible treatment of certain kinds of cancers. As part of the same surgery, a ureteral stent is often placed. The surgery and the stent can cause discomfort, and patients may receive narcotic pain medicine. In other surgeries, a single dose of pregabalin, around one hour before surgery has been shown to decrease the need for pain medication after the surgery. This work will test whether this is true in ureteroscopy by giving eligible patients who agree to participate either pregabalin or a placebo shortly before surgery then examining how much pain medication they use after surgery. A placebo is an inactive medication. Neither the study participant nor the study staff will know who received pregabalin and who received placebo until after the study is over. For completing surveys, patients will receive compensation for their time in the form of gift certificates.

Publications & conference data

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