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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: Completed Phase 2 study of Pain, Postoperative and Opioid Use, sponsored by University of Missouri-Columbia.
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 113 other Pain, Postoperative trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG Placebo oral tablet
- DRUG Pregabalin 300mg
Study Locations (1)
Missouri
- University of Missouri-Columbia - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2024-07-01 |
| Phase | Phase 2 |
What the finished NCT04122196 record still lists
NCT04122196 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 272-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (57% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04122196's enrollment target sits among peer trials
118 40th of 113 higher than 74 of 113 other Pain, Postoperative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain, Postoperative trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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