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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-10

Study Completion Date

2025-01-01

Brief Summary

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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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Detailed Description

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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

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Duloxetine Magnesium Sulphate Post-mastectomy Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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DM group

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

Group Type ACTIVE_COMPARATOR

Magnesium sulphate and Duloxetine

Intervention Type DRUG

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

D group

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

Group Type ACTIVE_COMPARATOR

Duloxetine

Intervention Type DRUG

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

Control group

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

Group Type PLACEBO_COMPARATOR

Placebo and normal saline

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Duloxetine

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

Intervention Type DRUG

Placebo and normal saline

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

Intervention Type DRUG

Other Intervention Names

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magnesium and cymbalta cymbalta placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No