Perioperative Pregabalin in Ureteroscopy: a Pilot

University of Missouri-Columbia10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nephrolithiasis Urolithiasis Perioperative/Postoperative Complications Pain, Postoperative Pain, Acute

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Day of surgery

Number of Participants Who Were Administered the Study Drug Correctly

Time frame: Day of surgery

Respondent Reported Usability of Instruments

Number of patients able to complete 30 day post op questionnaire

Time frame: 30 days post-op

Secondary Outcomes

Early Post-op Stent Related Symptoms

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.

Time frame: Post-op day 3

Early Post-op Opioid Needs

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

Time frame: First 30 post-operative days

Opioid Use

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

Time frame: Up to 1 year post-op

Amount of Opioid Use

Total amount of opioid used for any indication at several time points, in oral morphine equivalents. This is the sum for all patients.

Time frame: Up to 1 year post-op

Unplanned Healthcare Contacts

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

Time frame: First 30 post-operative days

Patient Satisfaction

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.

Time frame: First 30 post-operative days

Perioperative Pregabalin in Ureteroscopy: a Pilot

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes