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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 Postsurgical Pain, sponsored by NYU Langone Health.

Active
Registry status
Phase 3
Development phase
765
Enrollment target
14
Study locations

NCT05037123 is a Phase 3 study of Chronic Postsurgical Pain that is active but no longer recruiting, run by NYU Langone Health. The registered enrollment target is 765 participants. The trial reports 14 study locations across 10 states.

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The verdict

NCT05037123, a Phase 3 study of Chronic Postsurgical 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).

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

FieldValue
Enrollment Target 765 participants
Start Date 2022-01-04
Est. Completion 2026-08-31
Phase Phase 3

Sponsor

NYU Langone Health

1,164 total trials

What the Registry Record Tells You About NCT05037123

The ClinicalTrials.gov registry entry for NCT05037123 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 765 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Postsurgical Pain appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT05037123 reports 14 study locations spanning 10 distinct geographic areas - top geographies include 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 Postsurgical 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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