Perioperative Pregabalin in Ureteroscopy

NCT04122196 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2017676
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Stone; Pain, Postoperative; Addiction; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale of Pain Score

  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).

  1 hour after arrival to post anesthesia care unit

Secondary Outcomes (5)

• Oral Morphine Equivalents of Opioids Prescribed

  Within the first 30 days post-operation

• Proportion of Patients With Narcotic Prescription

  Within the first 30 days post-operation

• Number of Unplanned Healthcare Interactions

  Within the first 30 days post-operation

• Number of Serious Adverse Events

  Within the first 30 days post-operation

• Watson Clock Drawing Test Score

  1 hour after arrival to post anesthesia care unit

Other Outcomes (2)

• In-facility Oral Morphine Equivalents

  Day of surgery

• Nausea/Vomiting in PACU

  In post anesthesia care unit (usually approximately 1 hour post op)

Study Arms (2)

Pregabalin 300mg

EXPERIMENTAL

Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.

Drug: Pregabalin 300mg

Placebo

PLACEBO COMPARATOR

Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.

Drug: Placebo oral tablet

Interventions

Pregabalin 300mg DRUG

Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.

Also known as: Lyrica

Pregabalin 300mg

Placebo oral tablet DRUG

Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years
• Subject Population Undergoing elective ureteroscopy with stent placement at University of Missouri Hospital and affiliated facilities

You may not qualify if:

• Renal insufficiency (eGFR \< 60 mL/minute/1.73 m2)
• Chronic indwelling ureteral stent (\>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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Location

Related Publications (2)

• Ahles TA, Ruckdeschel JC, Blanchard EB. Cancer-related pain--II. Assessment with visual analogue scales. J Psychosom Res. 1984;28(2):121-4. doi: 10.1016/0022-3999(84)90004-7.

  PMID: 6737324 BACKGROUND

• Watson YI, Arfken CL, Birge SJ. Clock completion: an objective screening test for dementia. J Am Geriatr Soc. 1993 Nov;41(11):1235-40. doi: 10.1111/j.1532-5415.1993.tb07308.x.

  PMID: 8227899 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi; Pain, Postoperative; Behavior, Addictive

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Eliza DeFroda
• Organization: University of Missouri

elddmc@health.missouri.edu

573-882-4141

Study Officials

• Katie Murray, DO

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Urology

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 10, 2019
• Study Start: June 1, 2020
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2024
• Last Updated: November 12, 2025
• Results First Posted: October 24, 2024

Record last verified: 2025-10

Locations

US (1)