Trial Outcomes & Findings for Perioperative Pregabalin in Ureteroscopy: a Pilot (NCT NCT03927781)

NCT ID: NCT03927781

Last Updated: 2021-04-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 10 participants
• Primary outcome timeframe: Day of surgery
• Results posted on: 2021-04-19

Participant Flow

Participant milestones

Measure	Pregabalin 300mg 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Pregabalin 300mg n=10 Participants 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=10 Participants
Age, Categorical >=65 years	2 Participants n=10 Participants
Age, Continuous	40.2 years n=10 Participants
Sex: Female, Male Female	3 Participants n=10 Participants
Sex: Female, Male Male	7 Participants n=10 Participants
Region of Enrollment United States	10 Participants n=10 Participants

PRIMARY outcome

Timeframe: Day of surgery

Outcome measures

Measure	Pregabalin 300mg n=10 Participants 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Number of Participants With One or More Adverse Events Related to Study Drug	6 Participants

PRIMARY outcome

Timeframe: Day of surgery

Outcome measures

Measure	Pregabalin 300mg n=10 Participants 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Number of Participants Who Were Administered the Study Drug Correctly	10 Participants

PRIMARY outcome

Timeframe: 30 days post-op

Number of patients able to complete 30 day post op questionnaire

Outcome measures

Measure	Pregabalin 300mg n=10 Participants 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Respondent Reported Usability of Instruments	5 Participants

SECONDARY outcome

Timeframe: Post-op day 3

Population: Those who completed the questionnaire

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.

Outcome measures

Measure	Pregabalin 300mg n=5 Participants 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Early Post-op Stent Related Symptoms	88 score on a scale Interval 61.0 to 130.0

SECONDARY outcome

Timeframe: First 30 post-operative days

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

Outcome measures

Measure	Pregabalin 300mg n=10 Participants 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Early Post-op Opioid Needs	1 Participants

SECONDARY outcome

Timeframe: Up to 1 year post-op

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

Outcome measures

Measure	Pregabalin 300mg n=10 Participants 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Opioid Use	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Pregabalin 300mg n=10 Participants 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Amount of Opioid Use	90 oral morphine equivalents

SECONDARY outcome

Timeframe: First 30 post-operative days

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

Outcome measures

Measure	Pregabalin 300mg n=10 Participants 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Unplanned Healthcare Contacts	2 visits

SECONDARY outcome

Timeframe: First 30 post-operative days

Population: Respondents to the survey

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.

Outcome measures

Measure	Pregabalin 300mg n=6 Participants 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Patient Satisfaction	3.5 score on a scale Interval 1.0 to 5.0

Adverse Events

Pregabalin 300mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pregabalin 300mg n=10 participants at risk 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Nervous system disorders Pain	30.0% 3/10 • Events were systematically characterized on the day of surgery. Adverse events were otherwise by report up to 30 days after the patient's procedure.
Gastrointestinal disorders Increased appetite	10.0% 1/10 • Events were systematically characterized on the day of surgery. Adverse events were otherwise by report up to 30 days after the patient's procedure.
Nervous system disorders Back pain	10.0% 1/10 • Events were systematically characterized on the day of surgery. Adverse events were otherwise by report up to 30 days after the patient's procedure.
Gastrointestinal disorders Dry mouth	60.0% 6/10 • Events were systematically characterized on the day of surgery. Adverse events were otherwise by report up to 30 days after the patient's procedure.
Nervous system disorders Fatigue	10.0% 1/10 • Events were systematically characterized on the day of surgery. Adverse events were otherwise by report up to 30 days after the patient's procedure.
Nervous system disorders Confusion	10.0% 1/10 • Events were systematically characterized on the day of surgery. Adverse events were otherwise by report up to 30 days after the patient's procedure.
Nervous system disorders Somnolence	10.0% 1/10 • Events were systematically characterized on the day of surgery. Adverse events were otherwise by report up to 30 days after the patient's procedure.
Nervous system disorders Blurred vision	10.0% 1/10 • Events were systematically characterized on the day of surgery. Adverse events were otherwise by report up to 30 days after the patient's procedure.
Nervous system disorders Dizziness	10.0% 1/10 • Events were systematically characterized on the day of surgery. Adverse events were otherwise by report up to 30 days after the patient's procedure.

Additional Information

Dr Katie Murray

University of Missouri

Phone: 573-884-8768

Email: murraykat@health.missouri.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place