Kidney StonePhase 2/3NCT04122196
Perioperative Pregabalin in Ureteroscopy
A Phase 2/3 study testing Pregabalin 300mg in people with Kidney Stone and Pain, Postoperative, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
This is a randomized, placebo-controlled, double-blinded study examining the use of perioperative pregabalin in ureteroscopy with stent placement. Ureteroscopy is typically performed for kidney or ureteral stones, but may be performed for other reasons such as for the diagnosis and possible treatment of certain kinds… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone, Pain, Postoperative, Addiction
- What is being tested?
- Pregabalin 300mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 1 Jul 2024
- Phase
- Phase 2/3
- 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 Inclusion:
- Age >= 18 years
- Subject Population Undergoing elective ureteroscopy with stent placement at University of Missouri Hospital and affiliated facilities
Subject Exclusion:
- Renal insufficiency (eGFR < 60 mL/minute/1.73 m2)
- Chronic indwelling ureteral stent (>30 days in the previous year)
- Chronic opioid use
- History of opioid abuse
- Chronic gabapentinoid use
- History of gabapentinoid abuse
- 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
About this study
Official title: Perioperative Pregabalin as Part of a Multimodal Treatment Plan for Ureteral Stent Symptoms After Ureteroscopy: a Randomized Controlled Trial
This is a randomized, placebo-controlled, double-blinded study examining the use of perioperative pregabalin in ureteroscopy with stent placement. Ureteroscopy is typically performed for kidney or ureteral stones, but may be performed for other reasons such as for the diagnosis and possible treatment of certain kinds of cancers. As part of the same surgery, a ureteral stent is often placed. The surgery and the stent can cause discomfort, and patients may receive narcotic pain medicine. In other surgeries, a single dose of pregabalin, around one hour before surgery has been shown to decrease the need for pain medication after the surgery. This work will test whether this is true in ureteroscopy by giving eligible patients who agree to participate either pregabalin or a placebo shortly before surgery then examining how much pain medication they use after surgery. A placebo is an inactive medication. Neither the study participant nor the study staff will know who received pregabalin and who received placebo until after the study is over. For completing surveys, patients will receive compensation for their time in the form of gift certificates.
Read the detailed description
The prevalence of urolithiasis is greater than 8% and increasing in the United States. For those who require surgery, ureteroscopic treatment is common, representing >120,000 procedures yearly in the United States. This does not include ureteroscopy for other, including diagnosis of structural anomaly and diagnosis and management of ureteral and renal pelvic tumors. Frequently, a ureteral stent is placed intraoperatively. There is post-operative pain in around 80% of patients, and 12% of those undergoing ureteroscopy will have an emergency department visit in the first 30 post-operative days, typically for stent related symptoms or post procedural pain. Aside from the short-term repercussions of ureteroscopy with stent placement there are long-term issues related to pain and the treatment thereof. Recent evidence suggests that approximately 6% of opioid naïve patients who undergo ureteroscopy will become new persistent opioid users.
A single perioperative dose of pregabalin has been shown in many surgical contexts to have analgesic, anxiolytic, and opioid sparing effects. A common regimen employed in the literature is a single preoperative dose of 300mg PO pregabalin 1hr before induction of anesthesia. Pregabalin is a well-tolerated gabapentinoid medication with temporary cognition/coordination changes being the most common side effects. There is currently no standard of care for the use of perioperative gabapentinoid medication in ureteroscopy. A pilot was performed looking at such use that demonstrated the safety of this use and the feasibility of studying this at our institution.
In this work, the efficacy and safety of perioperative pregabalin in ureteroscopy with stent placement will be evaluated by executing a prospective, double blind, randomized, placebo-controlled trial for the use of perioperative pregabalin in the management of post-ureteroscopy symptoms, with the hypothesis that this treatment is safe and efficacious. Emphasis will be placed on patient-centered outcomes, especially those related to opioid sparing effects, mainly within the first 30 days after the surgery and extending out to one year.
The study will be powered with an 80% probability to detect a 10% difference in the primary outcomes. It will also assume a loss to follow up rate of 50%. This will require approximately 200 total subjects with a planned 1:1 placebo to active treatment enrollment ratio. The necessary enrollment can be accomplished in 11 months, allowing for 30 days of follow up within the funding period.
The final goal of this project will be at least one paper in a top urology journal. This will contribute to the literature by helping to inform urologists and anesthesiologists on the efficacy and safety of perioperative pregabalin for ureteroscopy with stent placement and will provide data regarding opioid sparing management after ureteroscopy. Opioid related issues abound nationwide and are evident in Missouri. This study has the potential to influence opioid use both in this state and nationwide as it relates to this frequently performed procedure.
- Conditions
- Kidney Stone, Pain, Postoperative, Addiction, Opioid Use
- Being tested
- Pregabalin 300mg, Placebo oral tablet
- Medical subject headings
- Kidney Calculi, Pain, Postoperative, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 300mgDrug
Also called Lyrica
Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
Placebo oral tabletDrug
Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin 300mg | Experimental | Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery. Receives: Drug: Pregabalin 300mg |
| Placebo | Placebo comparator | Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale of Pain Score
This was a visual analogue scale of pain as described in Ahles et al 1984. The patients were given a paper with a 10cm horizontal line on it. On the left was marked "No pain" and on the right "Worst pain imaginable". The patients were then asked to mark a vertical line along the 10cm line that indicated where their pain was. The score is the number of centimeters from the left. 0 is minimum (best). 10 maximum (worst).
Measured: 1 hour after arrival to post anesthesia care unit
Secondary outcomes (5)
Oral Morphine Equivalents of Opioids Prescribed
Measured: Within the first 30 days post-operation
Proportion of Patients With Narcotic Prescription
Measured: Within the first 30 days post-operation
Number of Unplanned Healthcare Interactions
Unplanned healthcare interactions include unplanned visits, emergency room visits, admissions to the hospital, and phone calls
Measured: Within the first 30 days post-operation
Number of Serious Adverse Events
Composite of unplanned serious adverse events including intensive care unit stay and death
Measured: Within the first 30 days post-operation
Watson Clock Drawing Test Score
This score is based on the scoring method described in Watson et al 1993. Higher scores demonstrate more errors. A clock is drawn. This is divided into quadrants. For errors in quadrants 1-3 (clock 12-8), a score of 1 is assigned. For errors in quadrant 4, a score of 4 is assigned. The scores are summed. Total scores range from 0 to 7 with 7 representing significant impairment (worst) and 0 representing no impairment (best).
Measured: 1 hour after arrival to post anesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start1 Jun 2020
- Primary completion1 Jul 2023
- Study completion1 Jul 2024
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eliza DeFroda, University of Missouri-Columbia
- Investigators
- Katie Murray, DO, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122196
- Sponsor's protocol ID
- 2017676
- Status last verified
- Oct 2025
- First submitted
- 8 Oct 2019
- Last updated
- 12 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ahles TA, Ruckdeschel JC, Blanchard EB. Cancer-related pain--II. Assessment with visual analogue scales. J Psychosom Res. 1984;28(2):121-4. doi: 10.1016/0022-3999(84)90004-7.
PubMed 6737324Watson YI, Arfken CL, Birge SJ. Clock completion: an objective screening test for dementia. J Am Geriatr Soc. 1993 Nov;41(11):1235-40. doi: 10.1111/j.1532-5415.1993.tb07308.x.
PubMed 8227899
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. 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 Ureteral Stent Symptoms After Ureteroscopy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04122196
- Acronym / sponsor ID
- 2017676
- Conditions
- Kidney Stone, Pain, Postoperative, Addiction, Opioid Use
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Posted 24 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, placebo-controlled, double-blinded study examining the use of perioperative pregabalin in ureteroscopy with stent placement. Ureteroscopy is typically performed for kidney or ureteral stones, but may be performed for other reasons such as for the diagnosis and possible treatment of certain kinds of cancers. As part of the same surgery, a ureteral stent is often placed. The surgery and the stent can cause discomfort, and patients may receive narcotic pain medicine. In other surgeries, a single dose of pregabalin, around one hour before surgery has been shown to decrease the need for pain medication after the surgery. This work will test whether this is true in ureteroscopy by giving eligible patients who agree to participate either pregabalin or a placebo shortly before surgery then examining how much pain medication they use after surgery. A placebo is an inactive medication. Neither the study participant nor the study staff will know who received pregabalin and who received placebo until after the study is over. For completing surveys, patients will receive compensation for their time in the form of gift certificates.
Detailed description
The prevalence of urolithiasis is greater than 8% and increasing in the United States. For those who require surgery, ureteroscopic treatment is common, representing >120,000 procedures yearly in the United States. This does not include ureteroscopy for other, including diagnosis of structural anomaly and diagnosis and management of ureteral and renal pelvic tumors. Frequently, a ureteral stent is placed intraoperatively. There is post-operative pain in around 80% of patients, and 12% of those undergoing ureteroscopy will have an emergency department visit in the first 30 post-operative days, typically for stent related symptoms or post procedural pain. Aside from the short-term repercussions of ureteroscopy with stent placement there are long-term issues related to pain and the treatment thereof. Recent evidence suggests that approximately 6% of opioid naïve patients who undergo ureteroscopy will become new persistent opioid users.
A single perioperative dose of pregabalin has been shown in many surgical contexts to have analgesic, anxiolytic, and opioid sparing effects. A common regimen employed in the literature is a single preoperative dose of 300mg PO pregabalin 1hr before induction of anesthesia. Pregabalin is a well-tolerated gabapentinoid medication with temporary cognition/coordination changes being the most common side effects. There is currently no standard of care for the use of perioperative gabapentinoid medication in ureteroscopy. A pilot was performed looking at such use that demonstrated the safety of this use and the feasibility of studying this at our institution.
In this work, the efficacy and safety of perioperative pregabalin in ureteroscopy with stent placement will be evaluated by executing a prospective, double blind, randomized, placebo-controlled trial for the use of perioperative pregabalin in the management of post-ureteroscopy symptoms, with the hypothesis that this treatment is safe and efficacious. Emphasis will be placed on patient-centered outcomes, especially those related to opioid sparing effects, mainly within the first 30 days after the surgery and extending out to one year.
The study will be powered with an 80% probability to detect a 10% difference in the primary outcomes. It will also assume a loss to follow up rate of 50%. This will require approximately 200 total subjects with a planned 1:1 placebo to active treatment enrollment ratio. The necessary enrollment can be accomplished in 11 months, allowing for 30 days of follow up within the funding period.
The final goal of this project will be at least one paper in a top urology journal. This will contribute to the literature by helping to inform urologists and anesthesiologists on the efficacy and safety of perioperative pregabalin for ureteroscopy with stent placement and will provide data regarding opioid sparing management after ureteroscopy. Opioid related issues abound nationwide and are evident in Missouri. This study has the potential to influence opioid use both in this state and nationwide as it relates to this frequently performed procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin 300mg | Experimental | Drug: Pregabalin 300mgPatient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery. |
| Placebo | Placebo comparator | Drug: Placebo oral tabletPatient will receive a compounded version of inactive placebo PO approximately one hour 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: LyricaPatient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery. | Drug | Pregabalin 300mg |
| Placebo oral tabletPatient will receive a compounded version of inactive placebo PO approximately one hour before surgery. | Drug | Placebo |
Primary outcome
Visual Analog Scale of Pain Score
Time frame: 1 hour after arrival to post anesthesia care unit
This was a visual analogue scale of pain as described in Ahles et al 1984. The patients were given a paper with a 10cm horizontal line on it. On the left was marked "No pain" and on the right "Worst pain imaginable". The patients were then asked to mark a vertical line along the 10cm line that indicated where their pain was. The score is the number of centimeters from the left. 0 is minimum (best). 10 maximum (worst).
5 secondary outcomes
Oral Morphine Equivalents of Opioids Prescribed
Time frame: Within the first 30 days post-operation
Proportion of Patients With Narcotic Prescription
Time frame: Within the first 30 days post-operation
Number of Unplanned Healthcare Interactions
Time frame: Within the first 30 days post-operation
Number of Serious Adverse Events
Time frame: Within the first 30 days post-operation
Watson Clock Drawing Test Score
Time frame: 1 hour after arrival to post anesthesia care unit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 6737324Ahles TA, Ruckdeschel JC, Blanchard EB. Cancer-related pain--II. Assessment with visual analogue scales. J Psychosom Res. 1984;28(2):121-4. doi: 10.1016/0022-3999(84)90004-7.
- Background: PubMed 8227899Watson YI, Arfken CL, Birge SJ. Clock completion: an objective screening test for dementia. J Am Geriatr Soc. 1993 Nov;41(11):1235-40. doi: 10.1111/j.1532-5415.1993.tb07308.x.
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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 2/3 study testing Pregabalin 300mg in people with Kidney Stone and Pain, Postoperative, 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 12 Nov 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 24 Oct 2024). 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?
Visual Analog Scale of Pain Score (time frame: 1 hour after arrival to post anesthesia care unit). 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 NCT04122196, which also lists 2 linked publications.
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 12 Nov 2025.