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

NCT06087211 | Completed

• 1 other identifier: AP2307-301-002
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Duloxetine; Magnesium Sulphate; Post-mastectomy Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Time to first analgesic request

  Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administared).

  48 hours postoperatively

Secondary Outcomes (5)

• Total morphine consumption

  48 hours postoperatively

• Degree of pain

  48 hours postoperatively

• Incidence of post-mastectomy pain syndrome

  12 weeks postoperatively

• Degree of patient satisfaction

  48 hours postoperatively

• Incidence of adverse events

  at 8 weeks postoperative and 12 weeks postoperative

Study Arms (3)

DM group

ACTIVE COMPARATOR

Patients received Duloxetine 30mg orally and an intravenous infusion of magnesium sulphate 50mg/kg mixed with 200 ml of normal saline.

Drug: Magnesium sulphate and Duloxetine

D group

ACTIVE COMPARATOR

Patients received Duloxetine 30mg orally and 200 ml of normal saline.

Drug: Duloxetine

Control group

PLACEBO COMPARATOR

Patients received a placebo capsule and an intravenous infusion of 200 mL of normal saline

Drug: Placebo and normal saline

Interventions

Magnesium sulphate and Duloxetine DRUG

Patients received Duloxetine 30mg orally and an intravenous infusion of magnesium sulphate 50mg/kg mixed with 200 ml of normal saline.

Also known as: magnesium and cymbalta

DM group

Duloxetine DRUG

Patients received Duloxetine 30mg orally and 200 ml of normal saline.

Also known as: cymbalta

D group

Placebo and normal saline DRUG

Patients received a placebo capsule and an intravenous infusion of 200 mL of normal saline.

Also known as: placebo

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female scheduled for modified radical mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 65 years old.
• American Society of Anesthesiologists (ASA) physical I-II
• Scheduled for modified radical mastectomy (MRM) under general anesthesia.

You may not qualify if:

• Liver or kidney disease
• Patient with previous chronic pain on opioids
• Patients on antidepressants and antipsychotics.
• Allergies to study drugs

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National cancer institute

Cairo, 11769, Egypt

Location

MeSH Terms

Interventions

Magnesium Sulfate; Duloxetine Hydrochloride; Magnesium; Saline Solution

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Thiophenes; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Metals, Alkaline Earth; Elements; Metals, Light; Metals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ahmed s abdelgalil, MD

  assistant professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Surgical ICU and Pain Management, National Cancer Institute, Cairo University

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 17, 2023
• Study Start: October 10, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)