NCT06087211

Pain Relieving Potentials of Combination of Oral Duloxetine and Intravenous Magnesium Sulphate in Post Mastectomy Pain

Pain Relieving Potentials of Preoperative Combination of Single Dose Oral Duloxetine and Intravenous Magnesium Sulphate in Acute and Chronic Post Mastectomy Pain: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: National Cancer Institute, Egypt · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the effect of combined duloxetine and IV Magnesium sulphate to decrease acute and chronic post mastectomy pain. The study will be conducted in National Cancer Institute and all the participants will be enrolled from female patients scheduled for modified radical mastectomy under general anesthesia in National Cancer Institute, Cairo University.

Detailed description

It has been reported recently that Duloxetine improved the quality of recovery in patients subjected to hysterectomy. In this context, mastectomy has a negative consequence starting from cancer diagnosis to the squeal of cancer-related treatments and it has been estimated that 20%-30% of patients with breast cancer suffer from depression and anxiety. Magnesium also antagonizes the release of inflammatory mediators such as histamine, serotonin, and cytokines in peripheral tissues.

Conditions

• Duloxetine
• Magnesium Sulphate
• Post-mastectomy Pain Syndrome

Interventions

Type	Name	Description
DRUG	Magnesium sulphate and Duloxetine	Patients received Duloxetine 30mg orally and an intravenous infusion of magnesium sulphate 50mg/kg mixed with 200 ml of normal saline.
DRUG	Duloxetine	Patients received Duloxetine 30mg orally and 200 ml of normal saline.
DRUG	Placebo and normal saline	Patients received a placebo capsule and an intravenous infusion of 200 mL of normal saline.

Timeline

• Start date: 2023-10-10
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2023-10-17
• Last updated: 2025-08-05

Locations

1 site across 1 country: Egypt