Mirtazapine for Acute and Chronic Post Mastectomy Pain

Assiut University

Status and phase: Completed; Early Phase 1

Conditions: Breast Cancer

Treatments: Drug: Mirtazapine 30 MG; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06499090

mirtazapine for post mastectoy

Details and patient eligibility

About

Our aim in this study will be to investigate the effect of mirtazapine on acute post-mastectomy pain manifested by total morphine consumption in first 24 hours and VAS score at rest and movement (primary outcomes). chronic neuropathic pain using LANSS Pain Scale (Leeds Assessment of Neuropathic Signs and Symptoms) and to evaluate the quality of recovery using the quality of recovery-40scoring system(QoR-40) (secondary outcomes) following modified radical mastectomy for breast cancer.

Enrollment: 62 patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

female patients aged 20-70 years scheduled for modified radical mastectomy with axillary dissection for breast carcinoma

Exclusion criteria

• known allergy to the study drugs significant organ dysfunction drug or alcohol abuse epilepsy patients with chronic pain or regularly receiving analgesics any psychiatric illness that would interfere with the perception and the assessment of pain

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups, including a placebo group

Mirtazapine group

Active Comparator group

Description:

patients will receive orally the night before surgery the study medication and daily up to two weeks after: Mirtazapine group: Mirtazapine 30 mg tablet

Treatment:

Drug: Mirtazapine 30 MG

placebo group

Placebo Comparator group

Description:

patients will receive orally the night before surgery the study medication and daily up to two weeks after: placebo tablet

Treatment:

Drug: Placebo