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ACTIVE NOT RECRUITING Phase 3

Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain

NCT05037123 · View on ClinicalTrials.gov ↗

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

1,204 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05037123

The ClinicalTrials.gov registry entry for NCT05037123 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 1,204 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05037123 reports 14 study locations spanning 10 distinct geographic areas — top geographies include New York, Texas, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05037123?

The interventions under investigation include: Placebo (OTHER), Continuous ketamine infusion (DRUG), Ketamine + Saline (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05037123?

This trial is sponsored by NYU Langone Health, which has 1,204 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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