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Completed

NCT Number: NCT03927781

Perioperative Pregabalin in Ureteroscopy: a Pilot

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.

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Key information

Conditions

Nephrolithiasis Acute Pain Anesthesia Anesthesia Morbidity Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Neurologic Manifestations Pain Pain, Acute Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Postoperative Complications Signs and Symptoms Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Subject Population Undergoing elective ureteroscopy with stent placement by Dr. Murray at University of Missouri Hospital and affiliated facilities

Subject Inclusion

Age >= 18 years

Subject Exclusion

  • Renal insufficiency (eGFR < 30 mL/minute/1.73 m2)
  • Chronic indwelling ureteral stent
  • Chronic opioid use
  • History of opioid abuse
  • Chronic gabapentinoid use
  • Plan for inpatient hospitalization
  • Pregnancy
  • Inability of the patient to consent for themselves in English
  • Allergy to gabapentinoid
  • Liver failure or hepatic dysfunction

Treatment and study plan

Pregabalin 300mg

Drug

One 300mg capsule will be administered PO 1 hour before surgery

Other names: Lyrica, Gabapentinoid

Primary outcomes

  1. Number of Participants With One or More Adverse Events Related to Study Drug

    Time frame: Day of surgery

  2. Number of Participants Who Were Administered the Study Drug Correctly

    Time frame: Day of surgery

  3. Respondent Reported Usability of Instruments

    Time frame: 30 days post-op

    Number of patients able to complete 30 day post op questionnaire

Secondary outcomes

  1. Early Post-op Stent Related Symptoms

    Time frame: 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.

  2. Early Post-op Opioid Needs

    Time frame: First 30 post-operative days

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

  3. Opioid Use

    Time frame: Up to 1 year post-op

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

  4. Amount of Opioid Use

    Time frame: 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.

  5. Unplanned Healthcare Contacts

    Time frame: First 30 post-operative days

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

  6. Patient Satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

Perioperative Pregabalin as Part of a Multimodal Treatment Plan for Pain After Ureteroscopy With Stent Placement: a Pilot

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 25, 2019
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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