NCT03468348

Duloxetine for Acute Post-mastectomy Pain

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	Duloxetine	patients scheduled for mastectomy and axillary evacuation for cancer breast will receive orally, 2 hours before the operation either, placebo capsule, duloxetine 30 mg,duloxetine 60 mg or duloxetine 90 mg capsule.

Timeline

• Start date: 2018-04-01
• Primary completion: 2020-02-10
• Completion: 2020-02-10
• First posted: 2018-03-16
• Last updated: 2020-06-24

Locations

1 site across 1 country: Egypt