NephrolithiasisPhase 3NCT03927781

Perioperative Pregabalin in Ureteroscopy: a Pilot

A Phase 3 study testing Pregabalin 300mg in people with Nephrolithiasis and Urolithiasis, run by University of Missouri-Columbia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Nephrolithiasis, Urolithiasis, Perioperative/Postoperative Complications
What is being tested?: Pregabalin 300mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2019to 17 Oct 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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 locations and contacts

1 site in 1 country.

United States1 site

University of Missouri-Columbia
Columbia, Missouri, 65212

Other trials in United States

About this study

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

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.

Conditions: Nephrolithiasis, Urolithiasis, Perioperative/Postoperative Complications, Pain, Postoperative, Pain, Acute, Anesthesia
Being tested: Pregabalin 300mg
Keywords: Pregabalin, Perioperative medicine, Opioid sparing, Urolithiasis, Ureteroscopy
Medical subject headings: Nephrolithiasis, Urolithiasis, Postoperative Complications, Pain, Postoperative, Acute Pain, Urologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pregabalin 300mgDrug
Also called Lyrica, Gabapentinoid
One 300mg capsule will be administered PO 1 hour before surgery

Study groups in NCT03927781
Study group	Role	What they receive
Pregabalin 300mg	Experimental	300mg pregabalin, PO, once, 1 hr before surgery Receives: Drug: Pregabalin 300mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With One or More Adverse Events Related to Study Drug
Measured: Day of surgery
Number of Participants Who Were Administered the Study Drug Correctly
Measured: Day of surgery
Respondent Reported Usability of Instruments
Number of patients able to complete 30 day post op questionnaire
Measured: 30 days post-op

Secondary outcomes (6)

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.
Measured: 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.
Measured: First 30 post-operative days
Opioid Use
Number of patients stating that they had used opioids on any survey.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: First 30 post-operative days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201917 Oct 2020

First posted25 Apr 2019
Study start1 Apr 2019
Primary completion17 Oct 2019
Study completion17 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NephrolithiasisStudies of the same condition, open and under way.
More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: All participants will receive 300mg PO pregabalin one hour before procedure start
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03927781
Sponsor's protocol ID: 2013680
Status last verified: Apr 2021
First submitted: 22 Apr 2019
Last updated: 19 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Dexamethasone for Ureteral STent Symptoms (DUSTS)
Ureteral Stent-Related Symptom
Not yet recruitingEarly Phase 1
Phosphate & Kidney Stones
Kidney Stones, Calcium Oxalate Kidney Stones
Recruiting
Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
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Active, not recruitingObservational study
A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System
Urolithiasis, Kidney Stone
Recruiting
Supervised Endoscopic Tele-controlled Intelligent Lithotripsy
Renal Stone

All Nephrolithiasis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Perioperative Pregabalin as Part of a Multimodal Treatment Plan for Pain After Ureteroscopy With Stent Placement: a Pilot
ClinicalTrials.gov ID: NCT03927781
Acronym / sponsor ID: 2013680
Conditions: Nephrolithiasis, Urolithiasis, Perioperative/Postoperative Complications, Pain, Postoperative, Pain, Acute, Anesthesia
Keywords: Pregabalin, Perioperative medicine, Opioid sparing, Urolithiasis, Ureteroscopy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of Missouri-ColumbiaUniversity, hospital or other
Study start: 1 Apr 2019 (actual)
Primary completion: 17 Oct 2019 (actual)
Study completion: 17 Oct 2020 (actual)
First posted: 25 Apr 2019 (actual)
Results: Posted 19 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: All participants will receive 300mg PO pregabalin one hour before procedure start

Arm	Type	Receives
Pregabalin 300mg	Experimental	Drug: Pregabalin 300mg300mg pregabalin, PO, once, 1 hr before surgery

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pregabalin 300mgAlso: Lyrica, GabapentinoidOne 300mg capsule will be administered PO 1 hour before surgery	Drug	Pregabalin 300mg

Primary outcome

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
Time frame: 30 days post-op
Number of patients able to complete 30 day post op questionnaire

6 secondary outcomes

Early Post-op Stent Related Symptoms
Time frame: Post-op day 3
Early Post-op Opioid Needs
Time frame: First 30 post-operative days
Opioid Use
Time frame: Up to 1 year post-op
Amount of Opioid Use
Time frame: Up to 1 year post-op
Unplanned Healthcare Contacts
Time frame: First 30 post-operative days
Patient Satisfaction
Time frame: First 30 post-operative days

Results and safety

Results posted to the registry on 19 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pregabalin 300mg	10	10

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

Time frame: Day of surgery. Count of participants. Unit: Participants

Measure	Pregabalin 300mg n = 10
Value	6

Primary outcome: Number of Participants Who Were Administered the Study Drug Correctly

Time frame: Day of surgery. Count of participants. Unit: Participants

Measure	Pregabalin 300mg n = 10
Value	10

Primary outcome: Respondent Reported Usability of Instruments

Time frame: 30 days post-op. Count of participants. Unit: Participants

Measure	Pregabalin 300mg n = 10
Value	5

6 secondary outcomes are reported in the full results.

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin 300mg	0 of 10 (0%)	6 of 10 (60%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Nephrolithiasis

RecruitingPhase 1/2
Dexamethasone for Ureteral STent Symptoms (DUSTS)
Ureteral Stent-Related Symptom
Not yet recruitingEarly Phase 1
Phosphate & Kidney Stones
Kidney Stones, Calcium Oxalate Kidney Stones
Recruiting
Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
Urolithiasis, Stones, Kidney
Active, not recruitingObservational study
A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System
Urolithiasis, Kidney Stone
Recruiting
Supervised Endoscopic Tele-controlled Intelligent Lithotripsy
Renal Stone

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Katie Murray, DO principal investigator

Assistant Professor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pregabalin 300mg in people with Nephrolithiasis and Urolithiasis, run by University of Missouri-Columbia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With One or More Adverse Events Related to Study Drug (time frame: Day of surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03927781.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.