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NCT04122196 · ClinicalTrials.gov registry record · Phase 2

Perioperative Pregabalin in Ureteroscopy

A Phase 2 study of Pain, Postoperative and Opioid Use, sponsored by University of Missouri-Columbia.

Completed
Registry status
Phase 2
Development phase
118
Enrollment target
1
Study location

NCT04122196 is a Phase 2 study of Pain, Postoperative and Opioid Use that has completed, run by University of Missouri-Columbia. The registered enrollment target is 118 participants, below the 272-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04122196, a Phase 2 study of Pain, Postoperative and Opioid Use, has completed, sponsored by University of Missouri-Columbia.

COMPLETED
Registry status
Phase 2
Development phase
118 participants
Enrollment target
1
Study location

Study 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 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.

Interventions

  • DRUG Placebo oral tablet
  • DRUG Pregabalin 300mg

Study Locations (1)

Missouri

  • University of Missouri-Columbia - Columbia

Trial Details

FieldValue
Enrollment Target 118 participants
Start Date 2020-06-01
Est. Completion 2024-07-01
Phase Phase 2

Sponsor

University of Missouri-Columbia

291 total trials

What the Registry Record Tells You About NCT04122196

The ClinicalTrials.gov registry entry for NCT04122196 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 272-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (57% lower). The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Pain, Postoperative appearing as the primary indexed condition, and to 2 interventions - of which Placebo oral tablet is the first listed.

NCT04122196 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.

Frequently Asked Questions

What is clinical trial NCT04122196 about?

NCT04122196 is a clinical study titled "Perioperative Pregabalin in Ureteroscopy". 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 treatmen...

What is the current status of trial NCT04122196?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2020-06-01. Estimated completion is 2024-07-01.

What conditions does trial NCT04122196 study?

This clinical trial studies the following conditions: Pain, Postoperative, Opioid Use, Kidney Stone, Addiction.

What interventions are being tested in trial NCT04122196?

The interventions under investigation include: Placebo oral tablet (DRUG), Pregabalin 300mg (DRUG).

Who is sponsoring clinical trial NCT04122196?

This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04122196 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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