Phase 3
Completed N=118
Perioperative Pregabalin in Ureteroscopy
Kidney Stone · Pain, Postoperative · Addictions · Opioid Use Disorder
Source: ClinicalTrials.gov NCT04122196 ↗
Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Visual Analog Scale of Pain Score — 3.7; 2.0 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale of Pain Score |
3.7; 2.0 | — |
| SECONDARY Oral Morphine Equivalents of Opioids Prescribed |
60; 50 | — |
| SECONDARY Proportion of Patients With Narcotic Prescription |
44; 35 | — |
| SECONDARY Number of Unplanned Healthcare Interactions |
8; 16 | — |
| SECONDARY Number of Serious Adverse Events |
0; 0 | — |
| SECONDARY Watson Clock Drawing Test Score |
1.8; 1.8 | — |
Eligibility Criteria
Subject Inclusion:
- Age >= 18 years
- Subject Population Undergoing elective ureteroscopy with stent placement at University of Missouri Hospital and affiliated facilities
Subject Exclusion:
- Renal insufficiency (eGFR 30 days in the previous year)
- Chronic opioid use
- History of opioid abuse
- Chronic gabapentinoid use
- History of gabapentinoid abuse
- Plan for inpatient hospitalization
- Pregnancy
- Inability of the patient to consent for themselves in English
- Allergy to gabapentinoid
- Liver failure or hepatic dysfunction
Data sourced from ClinicalTrials.gov (NCT04122196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.