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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Post-mastectomy Pain Syndrome

Intervention / Treatment
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* Drug: Duloxetine and magnesium sulphate
* Drug: Duloxetine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Duloxetine and magnesium sulphate<br>this group will receive Duloxetine orally and magnesium sulphate intravenous infusion 1 hour before surgery. | Drug: Duloxetine and magnesium sulphate<br>* 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<br>* Other names: cymbalta and magnesium sulphate;|
| Active Comparator: Duloxetine<br>this group will receive Duloxetine orally and 200ml normal saline infusion | Drug: Duloxetine<br>* this group will receive Duloxetine 30 mg orally and 200ml NS infusion 1 hour before surgery<br>* Other names: cymbalta;|
| Placebo Comparator: control<br>this will receive placebo capsule and an IV infusion of 200ml normal saline | Drug: placebo<br>* will receive placebo capsule and an IV infusion of 200ml NS 1 hour before surgery<br>* Other names: control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first analgesic request | time to first dose of rescue analgesia | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morphine consumption | amount of morphine consumed (mg) | 24 hours after surgery | 
| visual analogue scale score | 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 | at 2 hour,6 hour, 12 hour and 24 hour | 
| incidence of post mastectomy pain syndrome | incidence of post mastectomy pain syndrome | at 8 weeks postoperative and 12 weeks postoperative |