Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain (NCT05037123) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain
United States765 participantsStarted 2022-01-04
Plain-language 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).
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…