Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain

Overview

About this study

The purpose of this study is to measure the effectiveness of ketamine in reducing chronic post-mastectomy pain.  

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Woman 18 years of age or older.

- Undergoing elective breast surgery for oncologic indication as follows: unilateral or bilateral mastectomy,  prophylactic-mastectomy, +/- 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.

Eligibility last updated 5/31/22. Questions regarding updates should be directed to the study team contact. 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

William Hooten, M.D.

Open for enrollment

Contact information:

Sharon Svoboda R.N.

(507) 255-8248

Svoboda.Sharon@mayo.edu

More information

Publications

Publications are currently not available