Duloxetine for Acute Post-mastectomy Pain

Duloxetine for Acute Post-mastectomy Pain: Placebo Controlled Dose Ranging Study

The objective of this study is to evaluate the analgesic effect of oral dulexitine tablet (administered 2 h before surgery) as well as the ideal dose for acute postmastectomy pain.

patients undergoing mastectomy with axillary evacuation will be divided to four groups, Placebo group: received placebo capsule Duloxetine 30: received duloxetine 30 mg capsule Duloxetine 60: received duloxetine 60 mg capsule Duloxetine 90: received duloxetine 90 mg capsule the study medication is administered orall 2 h before surgery. Primary outcome variable: the first postoperative 24 h morphine consumption Secondary outcome: the VAS pain score measured every 4 h in the first 24 h postoperatively.

Inclusion Criteria:

• Adult females scheduled for unilateral MRM with axillary evacuation for breast cancer,
• American Society of Anesthesiologists physical status (ASA) class I and II

Exclusion Criteria:

• Patients with a known allergy to Duloxetine or morphine,
• A history of drug or alcohol abuse,
• Patients with impaired kidney or liver functions,
• Patients with chronic pain or regularly receiving analgesics,
• Any psychiatric illness that would interfere with the perception and the assessment of pain.
• Any reason that resulted in the protocol violation.