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NCT05037123 · ClinicalTrials.gov registry record · Phase 3
Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain
A Phase 3 study of Chronic Post Surgical Pain, sponsored by NYU Langone Health.
- Active
- Registry status
- Phase 3
- Development phase
- 765
- Enrollment target
- 14
- Study locations
NCT05037123: Active Phase 3 study of Chronic Post Surgical Pain, sponsored by NYU Langone Health.
NCT05037123 is a Phase 3 study of Chronic Post Surgical Pain that is active but no longer recruiting, run by NYU Langone Health. The registered enrollment target is 765 participants, above the 193-participant average among 4 other Chronic Post Surgical Pain trials with a reported enrollment target (296% higher). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05037123, a Phase 3 study of Chronic Post Surgical Pain, is active but no longer recruiting, sponsored by NYU Langone Health.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 765 participants
- Enrollment target
- 14
- Study locations
Study Summary
The study utilizes a 3-arm placebo-controlled RCT to study the effectiveness of ketamine in reducing chronic post-mastectomy pain. Participants randomized to the first arm will receive a 0.35 mg/kg dose after induction, followed by a 0.25 mg/kg/hr infusion during surgery (up to a maximum of 6 hours) and continued for 2 hours postoperatively. Participants in the second arm will receive a single dose of 0.6 mg/kg of ketamine in the post-anesthesia care unit, and the final group will serve as the control group and receive saline (no ketamine).
Primary Outcome
The Brief Pain Inventory short form (BPI) pain severity subscale assesses pain at its worst, least, average, and current in the past 24 hours. The score ranges from 0 to 10 for each item. The average of the four items will be used. The BPI scale defines pain as follows: Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Continuous ketamine infusion
- DRUG Ketamine + Saline
Study Locations (14)
New York
- NYU Langone Health (Tisch Hospital, Kimmel Pavilion) - New York
- New York Presbyterian Columbia University Irving Medical Center - New York
- Memorial Sloan Kettering Cancer Center - New York
- Montefiore Medical Center - Albert Einstein College of Medicine - The Bronx
Texas
- University of Texas - Southwestern Medical Center - Dallas
- University of Texas - MD Anderson Cancer Center - Houston
Alabama
- University of Alabama at Birmingham - Birmingham
Arkansas
- University of Arkansas - Little Rock
Illinois
- Rush University Medical Center - Chicago
Massachusetts
- Brigham and Women's Hospital - Harvard University - Chestnut Hill
Minnesota
- Mayo Clinic - Rochester
Missouri
- Washington University at St. Louis Medical Center - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 765 participants |
| Start Date | 2022-01-04 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 3 |
What the registry record for NCT05037123 still lists
NCT05037123 is an interventional study that assigns participants to a tested intervention. The registered 765 participants enrollment target is mid-sized for trials with a published cap, above the 193-participant average among 4 other Chronic Post Surgical Pain trials with a reported enrollment target (296% higher).
The record links to 1 condition, with Chronic Post Surgical Pain appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05037123 lists 14 locations in 10 states (New York, Texas, Alabama).
Frequently Asked Questions
What is clinical trial NCT05037123 about?
NCT05037123 is a clinical study titled "Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain". The study utilizes a 3-arm placebo-controlled RCT to study the effectiveness of ketamine in reducing chronic post-mastectomy pain. Participants randomized to the first arm will receive a 0.35 mg/kg dose after induction, followed by a 0.25 mg/kg/hr infusion during surgery (up to a maximum of 6 hours)...
What is the current status of trial NCT05037123?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 765 participants. The study started on 2022-01-04. Estimated completion is 2026-08-31.
What conditions does trial NCT05037123 study?
This clinical trial studies the following conditions: Chronic Post Surgical Pain.
What interventions are being tested in trial NCT05037123?
The interventions under investigation include: Placebo (OTHER), Continuous ketamine infusion (DRUG), Ketamine + Saline (DRUG).
Who is sponsoring clinical trial NCT05037123?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05037123 being conducted?
This trial has 14 study locations across Alabama, Arkansas, Illinois, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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