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

Sponsor
National Cancer Institute, Egypt (Other)
Overall Status
Recruiting
CT.gov ID
NCT06087211
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
5.7
Anticipated Duration (Months)
15.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official 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
Actual Study Start Date :
Oct 10, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Duloxetine and magnesium sulphate

this group will receive Duloxetine orally and magnesium sulphate intravenous infusion 1 hour before surgery.

Drug: Duloxetine and magnesium sulphate
this group will receive Duloxetine 30 mg orally and an intravenous (IV) infusion of magnesium sulphate 50mg/kg mixed with 200ml normal saline (NS) 1 hour before surgery
Other Names:
  • cymbalta and magnesium sulphate

    		•
    Active Comparator: Duloxetine

    this group will receive Duloxetine orally and 200ml normal saline infusion

    Drug: Duloxetine
    this group will receive Duloxetine 30 mg orally and 200ml NS infusion 1 hour before surgery
    Other Names:
  • cymbalta

    		•
    Placebo Comparator: control

    this will receive placebo capsule and an IV infusion of 200ml normal saline

    Drug: placebo
    will receive placebo capsule and an IV infusion of 200ml NS 1 hour before surgery
    Other Names:
  • control

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to first analgesic request [24 hours after surgery]

      time to first dose of rescue analgesia

    Secondary Outcome Measures

    1. Postoperative morphine consumption [24 hours after surgery]

      amount of morphine consumed (mg)

    2. visual analogue scale score [at 2 hour,6 hour, 12 hour and 24 hour]

      assessment of postoperative pain using the visual analogue scale score. the scale is a straight horizontal line (100 mm). The ends are defined as the extreme limits of pain orientated from the left (no pain) to the right (worst pain).The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.higher VAS score means worse pain

    3. incidence of post mastectomy pain syndrome [at 8 weeks postoperative and 12 weeks postoperative]

      incidence of post mastectomy pain syndrome

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

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

    • Scheduled for 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National cancer institute Cairo Egypt 11769

    Sponsors and Collaborators

    • National Cancer Institute, Egypt

    Investigators

    • Principal Investigator: Ahmed Salah abdelgalil, MD, National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute, Egypt
    ClinicalTrials.gov Identifier:
    NCT06087211
    Other Study ID Numbers:
    • AP2307-301-002
    First Posted:
    Oct 17, 2023
    Last Update Posted:
    Oct 17, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Magnesium Sulfate
    Duloxetine Hydrochloride

    Study Results

    No Results Posted as of Oct 17, 2023