Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain
Active, not recruitingPhase 3NCT05037123
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain
- Conditions
- Interventions
- Drug: Continuous ketamine infusion
- Drug: Ketamine + Saline
- Other: Placebo
- Sponsor
- NYU Langone Health
- Collaborators
- National Cancer Institute (NCI)
- Start date
- 2022-01-04
- Primary completion
- 2025-05-28
- Sex
- Female
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 14
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Woman 18 years of age or older * Undergoing elective breast surgery for oncologic indication as follows: unilateral or bilateral mastectomy, prophylacticmastectomy, +/- lymph node dissection, +/- immediate or delayed reconstruction. * No distant metastases Exclusion Criteria: * History of cognitive impairment or clinical signs of altered mental status (AMS) that may interfere with adherence to study procedures and/or participant safety. Clinical signs of AMS may include but are not limited to: confusion, amnesia, disorientation, fluctuating levels of alertness, etc. * Past ketamine or phencyclidine misuse or abuse * Schizophrenia or history of psychosis * History of post-traumatic stress disorder * Known sensitivity or allergy to ketamine * Liver or renal insufficiency * History of uncontrolled hypertension, chest pain, cardiac arrhythmia, stroke, head trauma, intracranial mass or hemorrhage, glaucoma, porphyria, uncontrolled thyroid disease, or other contraindication to ketamine * Lamotrigine, alfentanil, physostigmine, or 4-aminopyridine use * Currently Pregnant * Body mass index (BMI) equal to or greater than 41 * Non-English or non-Spanish speaker * Currently participating in another pain interventional trial * Unwilling to comply with all study procedures and be available for the duration of the study * Patient is American Society of Anesthesiologists (ASA) physical status 4, 5, or 6 * Patient has started or undergone hormone therapy for gender transition into male. * Patient scheduled for any bilateral (or greater) flap reconstruction
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05037123