Mirtazapine for Acute and Chronic Post Mastectomy Pain

NCT ID: NCT06499090

Last Updated: 2026-01-22

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

EARLY_PHASE1

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Mirtazapine group

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

Group Type ACTIVE_COMPARATOR

Mirtazapine 30 MG

Intervention Type DRUG

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

placebo group

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

placebo tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Mirtazapine 30 MG

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ali Rabiee Ali

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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south Egypt Cancer Institute Assiut University

Asyut, , Egypt

Site Status

Countries

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Egypt

Related Links

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https://pubmed.ncbi.nlm.nih.gov/22342987/

combination of mirtazapine and milnacipran augments the extracellular levels of monoamines in the rat brain.

Other Identifiers

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mirtazapine for post mastectoy

Identifier Type: -

Identifier Source: org_study_id

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