Duloxetine for Acute Post-mastectomy Pain

Assiut University

Status: Completed

Conditions: Acute Pain

Treatments: Drug: Duloxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT03468348

SECI-IRB-IORG0006563-437

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 88 patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 4 patient groups, including a placebo group

placebo group

Placebo Comparator group

Treatment:

Drug: Duloxetine

duloxetine 30

Active Comparator group

Treatment:

Drug: Duloxetine

duloxetine 60

Active Comparator group

Treatment:

Drug: Duloxetine

duloxetine 90

Active Comparator group

Treatment:

Drug: Duloxetine