Perioperative Pregabalin in Ureteroscopy: a Pilot

University of Missouri (MU)

Status and phase: Completed; Phase 3

Conditions: Anesthesia Morbidity; Perioperative/Postoperative Complications; Urolithiasis; Pain, Acute; Pain, Postoperative; Nephrolithiasis; Urologic Diseases; Anesthesia

Treatments: Drug: Pregabalin 300mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03927781

2013680

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Pregabalin 300mg

Experimental group

Description:

300mg pregabalin, PO, once, 1 hr before surgery

Treatment:

Drug: Pregabalin 300mg