Perioperative Pregabalin in Ureteroscopy: a Pilot

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03927781
• Other study ID #: 2013680
• Status: Completed
• Phase: Phase 3
• Start date: April 1, 2019
• Est. completion date: October 17, 2020

Study information

• Verified date: April 2021
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 17, 2020
• Est. primary completion date: October 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Anesthesia
• Anesthesia Morbidity
• Kidney Calculi
• Nephrolithiasis
• Pain, Acute
• Pain, Postoperative
• Perioperative/Postoperative Complications
• Postoperative Complications
• Urinary Calculi
• Urolithiasis
• Urologic Diseases

Intervention

Drug:
• Pregabalin 300mg
One 300mg capsule will be administered PO 1 hour before surgery

Locations

Country	Name	City	State
United States	University of Missouri-Columbia	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With One or More Adverse Events Related to Study Drug		Day of surgery
Primary	Number of Participants Who Were Administered the Study Drug Correctly		Day of surgery
Primary	Respondent Reported Usability of Instruments	Number of patients able to complete 30 day post op questionnaire	30 days post-op
Secondary	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.	Post-op day 3
Secondary	Early Post-op Opioid Needs	Number of patients with a verified prescription for narcotic medication within the first 30 post-operative days.	First 30 post-operative days
Secondary	Opioid Use	Number of patients stating that they had used opioids on any survey.	Up to 1 year post-op
Secondary	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.	Up to 1 year post-op
Secondary	Unplanned Healthcare Contacts	Number of unplanned contacts between the patient and the healthcare system. This is the total for all patients.	First 30 post-operative days
Secondary	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.	First 30 post-operative days