Effect of Postoperative Single Dose of Ketamine on Pain After Mastectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Ketamine; Placebo
Intervention description: Ketamine at a dose of 0.6 mg/kg will be administered intravenously (IV) while the participant is recovering in the PACU. The study drug will be administered over at least 30 minutes at one time point and will be administered after subject has been deemed to be stable (hemodynamically stable, awake) by the study team on POD 0.; Matching equal dose of saline placebo will be administered intravenously while the participant is recovering in the PACU.
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 31.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Mastectomy

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.
    

Eligibility 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