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

Last updated: May 5, 2025
Sponsor: National Cancer Institute, Egypt
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Duloxetine and magnesium sulphate

Placebo and normal saline

placebo

Clinical Study ID

NCT06087211
AP2307-301-002
  • Ages 18-65
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age from 18 to 65 years old.

  • American Society of Anesthesiologists (ASA) physical I-II

  • Scheduled for modified radical mastectomy (MRM) under general anesthesia.

Exclusion

Exclusion Criteria:

  • Liver or kidney disease

  • Patient with previous chronic pain on opioids

  • Patients on antidepressants and antipsychotics.

  • Allergies to study drugs

Study Design

Total Participants: 90
Treatment Group(s): 5
Primary Treatment: Duloxetine and magnesium sulphate
Phase:
Study Start date:
October 10, 2023
Estimated Completion Date:
January 01, 2025

Study 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.

Connect with a study center

  • National cancer institute

    Cairo, 11769
    Egypt

    Site Not Available

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