Effect of Postoperative Single Dose of Ketamine on Pain After Mastectomy

• Status: Recruiting
• Trial end date: 2021-11-19
• Target enrollment: 0
• Participant gender: Female

Summary

This is a randomized, single blinded, placebo-controlled trial to study the effectiveness of a subanesthetic dose (0.6mg/kg) of ketamine versus placebo (saline) on postoperative pain on adult women undergoing mastectomy.

The objective of the study is to examine the effect of a subanesthetic dose (0.6mg/kg) of ketamine vs. saline control on postoperative pain in subjects who have undergone mastectomy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NYU Langone Health
• Treatments: Ketamine

Criteria

Inclusion Criteria:

1. Adult women, aged 18 to 80 years old, who will undergo mastectomy.

2. Willing to comply with all study procedures and be available for the duration of the study.

3. Will be scheduled for elective breast surgery for oncologic indication as follows:

mastectomy +/- lymph node dissection, prophylactic mastectomy, unilateral or bilateral, with immediate reconstruction

4. No distant metastases.

5. Subject is American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.

6. Subject is medically stable.

Exclusion Criteria:

1. Cognitive impairment (by history) or clinical signs of altered mental status such as confusion, amnesia, disorientation, fluctuating levels of alertness, etc. that may interference with adherence to study procedures and/or participant safety.

2. Past ketamine or phencyclidine misuse or abuse.

3. Schizophrenia or history of psychosis.

4. Known sensitivity or allergy to ketamine.

5. Liver or renal insufficiency.

6. History of uncontrolled hypertension, chest pain, cardiac arrythmia, stroke, head trauma, intracranial mass or hemorrhage or pressure, glaucoma, acute globe injury, uncontrolled thyroid disease, porphyria, or any other contraindication to ketamine. Use of lamotrigine, alfentanil, physostigmine, and 4-aminopyridine are contraindicated

7. Pregnancy or nursing women

8. BMI>35.

9. Currently participating in another pain interventional trial.

10. Unwillingness to give informed consent.

11. Non-English speaking patients as QoR-15 and BCPQ have not been validated in all other languages