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Completed

NCT Number: NCT06499090

Mirtazapine for Acute and Chronic Post Mastectomy Pain

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

south Egypt Cancer Institute Assiut University

Asyut, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mirtazapine 30 MG

Drug

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

Placebo

Drug

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

Primary outcomes

  1. The cumulative postoperative 24 h morphine consumption

    Time frame: 24 hours

Secondary outcomes

  1. The visual analogue score of pain intensity

    Time frame: 24 hours

    VAS score of pain intensity at rest and arm movement (abduction of the arm of the operated side up to 90°) measured at (0, 2,4,8,12,16 and 24h) postoperatively.

  2. The quality of recovery-40 questionnaire

    Time frame: 24 hours

    1 means very poor recover and 40 very good recovery

  3. Assessment of sedation level

    Time frame: 24 hours

    Assessment of sedation level by the Modified Ramsay Sedation score

  4. Assessment of chronic pain

    Time frame: 6 months

    Assessment of chronic pain will be done after the first, third and Sixth month post-operatively by LANSS to evaluate chronic pain in the Pain Clinic.

  5. Depression score

    Time frame: 6 months

    Depression score by the Patient Health Questionnaire(PHQ9)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

The Effect of Peri-operative Mirtazapine on Acute and Chronic Post Mastectomy Pain (Prospective Randomized Controlled Study)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2024
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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