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NCT Number: NCT06087211

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

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.

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Key information

Conditions

Duloxetine Magnesium Sulphate Post-mastectomy Pain Syndrome

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National cancer institute

Cairo, 11769, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 criteria

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

Treatment and study plan

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.

Other names: magnesium and cymbalta

Duloxetine

Drug

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

Other names: cymbalta

Placebo and normal saline

Drug

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

Other names: placebo

Primary outcomes

  1. Time to first analgesic request

    Time frame: 48 hours postoperatively

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

Secondary outcomes

  1. Total morphine consumption

    Time frame: 48 hours postoperatively

    Postoperative analgesia is composed of PCA-morphine, set to deliver 2 mg boluses on-demand without background infusion with a lockout period of 10 min and regular intravenous paracetamol, one gram every 8 h.

  2. Degree of pain

    Time frame: 48 hours postoperatively

    Each patient was instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at post-anesthesia care unit (PACU), 1, 2, 4, 6, 8, 12, 24, 36 and 48 h postoperatively.

  3. Incidence of post-mastectomy pain syndrome

    Time frame: 12 weeks postoperatively

    Incidence of post-mastectomy pain syndrome was determined at 8- and 12-weeks post-mastectomy.

  4. Degree of patient satisfaction

    Time frame: 48 hours postoperatively

    The degree of patient satisfaction was assessed on a 5-point Likert scale (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).

  5. Incidence of adverse events

    Time frame: at 8 weeks postoperative and 12 weeks postoperative

    Incidence of adverse events such as bradycardia, hypotension, postoperative nausea and vomiting (PONV) were recorded.

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 17, 2023
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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