Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

Our 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 0.3 mg/kg/hr infusion throughout surgery 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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NYU Langone Health
• Collaborator: National Cancer Institute (NCI)
• Treatments: Ketamine

Criteria

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) greater than 35

• 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