Does Low-Dose Ketamine Administration Around The Time Of Surgery Reduce Chronic Pain After Mastectomy?
Posted Date: Apr 22, 2024
- Investigator: Brian Vaughan
- Specialties: Breast Cancer, Cancer, Women's Health
- Type of Study: Drug
Title: Optimizing the use of ketamine to reduce chronic postsurgical pain Précis: 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 0.25 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). Objectives: Primary: To determine the effectiveness of continuous ketamine infusion and single-dose ketamine to reduce pain at the surgical site at 3 months after surgery as assessed by the Brief Pain Inventory (BPI) pain severity subscale. Secondary: To determine the effect of continuous ketamine infusion and single-dose ketamine on postoperative pain, function, and mood. Population: Approximately 750 adult women undergoing mastectomy or prophylactic mastectomy (+/- lymph node dissection) across the United States. Phase or Stage: Phase 3 Anticipated Number of Sites: 16 Sites Description of Intervention/ Experimental Manipulation: First arm: Continuous ketamine infusion (0.35 mg/kg after induction, followed by 0.25 mg/kg/hr infusion up to a maximum of 6 hours intraoperatively, followed by 2 hours of infusion postoperatively) plus saline IV dose in post-anesthesia care unit Second arm: Saline dose and infusion intraoperatively, then single-dose IV ketamine (0.60 mg/kg) in post-anesthesia care unit plus 2 hours of saline administration after surgery Third arm: Placebo, Saline dose and infusion intraoperatively, then saline IV dose in post-anesthesia care unit plus 2 hours of saline administration after surgery Study Duration: 48 months (4 years)
Criteria:
Eligible Patients Are Women 18 Years Of Age Or Older Who Are Undergoing Either Prophylactic Or Therapeutic Mastecomy And Have No Known Distant Metastases.
Keywords:
Breast Cancer, Ketamine, Mastecomy
For More Information:
Brian Vaughan
513-258-6313
vaughaba@ucmail.uc.edu