Perioperative Pregabalin in Ureteroscopy: a Pilot

• Sponsor: University of Missouri-Columbia (Other)
• Overall Status: Completed
• CT.gov ID: NCT03927781
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 18.6
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nephrolithiasis; Urolithiasis; Perioperative/Postoperative Complications; Pain, Postoperative; Pain, Acute; Anesthesia; Urologic Diseases; Anesthesia Morbidity	Drug: Pregabalin 300mg	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All participants will receive 300mg PO pregabalin one hour before procedure startAll participants will receive 300mg PO pregabalin one hour before procedure start
• Masking: None (Open Label)
• Masking Description: There will be no blinding for this pilot
• Primary Purpose: Treatment
• Official Title: Perioperative Pregabalin as Part of a Multimodal Treatment Plan for Pain After Ureteroscopy With Stent Placement: a Pilot
• Actual Study Start Date: Apr 1, 2019
• Actual Primary Completion Date: Oct 17, 2019
• Actual Study Completion Date: Oct 17, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pregabalin 300mg 300mg pregabalin, PO, once, 1 hr before surgery	Drug: Pregabalin 300mg; One 300mg capsule will be administered PO 1 hour before surgery; Other Names: Lyrica Gabapentinoid

Outcome Measures

Primary Outcome Measures

1. Number of Participants With One or More Adverse Events Related to Study Drug [Day of surgery]

2. Number of Participants Who Were Administered the Study Drug Correctly [Day of surgery]

3. Respondent Reported Usability of Instruments [30 days post-op]

   Number of patients able to complete 30 day post op questionnaire

Secondary Outcome Measures

1. Early Post-op Stent Related Symptoms [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 [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 [Up to 1 year post-op]

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

4. Amount of Opioid Use [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Missouri-Columbia	Columbia	Missouri	United States	65212

Sponsors and Collaborators

• University of Missouri-Columbia

Investigators

• Principal Investigator: Katie Murray, DO, Assistant Professor

Study Documents (Full-Text)

• Study Protocol and Informed Consent Form - Mar 13, 2019
• Statistical Analysis Plan - Nov 20, 2019

More Information

Publications

None provided.

• Responsible Party: Katie Murray, Assistant Professor, University of Missouri-Columbia
• ClinicalTrials.gov Identifier: NCT03927781
• Other Study ID Numbers: 2013680
• First Posted: Apr 25, 2019
• Last Update Posted: Apr 19, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Katie Murray, Assistant Professor, University of Missouri-Columbia: Pregabalin; Perioperative medicine; Opioid sparing; Urolithiasis; Ureteroscopy
• Additional relevant MeSH terms: Urolithiasis; Urinary Calculi; Nephrolithiasis; Kidney Calculi; Urologic Diseases; Pain, Postoperative; Postoperative Complications; Acute Pain; Pregabalin

Study Results

Participant Flow

Arm/Group Title	Pregabalin 300mg
Arm/Group Description	300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Pregabalin 300mg
Arm/Group Description	300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 80%
>=65 years	2 20%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	40.2
Sex: Female, Male (Count of Participants)
Female	3 30%
Male	7 70%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	10 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With One or More Adverse Events Related to Study Drug
Time Frame	Day of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pregabalin 300mg
Arm/Group Description	300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Measure Participants	10
Count of Participants [Participants]	6 60%

2. Primary Outcome

Title	Number of Participants Who Were Administered the Study Drug Correctly
Time Frame	Day of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pregabalin 300mg
Arm/Group Description	300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Measure Participants	10
Count of Participants [Participants]	10 100%

3. Primary Outcome

Title	Respondent Reported Usability of Instruments
Description	Number of patients able to complete 30 day post op questionnaire
Time Frame	30 days post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pregabalin 300mg
Arm/Group Description	300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Measure Participants	10
Count of Participants [Participants]	5 50%

4. Secondary Outcome

Title	Early Post-op Stent Related Symptoms
Description	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

Outcome Measure Data

Analysis Population Description

Those who completed the questionnaire

Arm/Group Title	Pregabalin 300mg
Arm/Group Description	300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Measure Participants	5
Mean (Full Range) [score on a scale]	88

5. Secondary Outcome

Title	Early Post-op Opioid Needs
Description	Number of patients with a verified prescription for narcotic medication within the first 30 post-operative days.
Time Frame	First 30 post-operative days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pregabalin 300mg
Arm/Group Description	300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Measure Participants	10
Count of Participants [Participants]	1 10%

6. Secondary Outcome

Title	Opioid Use
Description	Number of patients stating that they had used opioids on any survey.
Time Frame	Up to 1 year post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pregabalin 300mg
Arm/Group Description	300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Measure Participants	10
Count of Participants [Participants]	1 10%

7. Secondary Outcome

Title	Amount of Opioid Use
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pregabalin 300mg
Arm/Group Description	300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Measure Participants	10
Number [oral morphine equivalents]	90

8. Secondary Outcome

Title	Unplanned Healthcare Contacts
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pregabalin 300mg
Arm/Group Description	300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Measure Participants	10
Number [visits]	2

9. Secondary Outcome

Title	Patient Satisfaction
Description	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

Outcome Measure Data

Analysis Population Description

Respondents to the survey

Arm/Group Title	Pregabalin 300mg
Arm/Group Description	300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
Measure Participants	6
Mean (Full Range) [score on a scale]	3.5

Adverse Events

Time Frame	Events were systematically characterized on the day of surgery. Adverse events were otherwise by report up to 30 days after the patient's procedure.
Arm/Group Title	Pregabalin 300mg
Arm/Group Description	300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
All Cause Mortality
	Pregabalin 300mg
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Pregabalin 300mg
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Pregabalin 300mg
	Affected / at Risk (%)	# Events
Total	6/10 (60%)
Gastrointestinal disorders
Increased appetite	1/10 (10%)
Dry mouth	6/10 (60%)
Nervous system disorders
Pain	3/10 (30%)
Back pain	1/10 (10%)
Fatigue	1/10 (10%)
Confusion	1/10 (10%)
Somnolence	1/10 (10%)
Blurred vision	1/10 (10%)
Dizziness	1/10 (10%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.