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

National Cancer Institute, Egypt

Status: Completed

Conditions: Magnesium Sulphate; Duloxetine; Post-mastectomy Pain Syndrome

Treatments: Drug: Magnesium sulphate and Duloxetine; Drug: Duloxetine; Drug: Placebo and normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06087211

AP2307-301-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

DM group

Active Comparator group

Description:

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

Treatment:

Drug: Magnesium sulphate and Duloxetine

D group

Active Comparator group

Description:

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

Treatment:

Drug: Duloxetine

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo and normal saline