Mirtazapine for Acute and Chronic Post Mastectomy Pain

NCT06499090 — Early Phase 1, Completed, 62 participants, Assiut University

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

Registry	NCT06499090
Status	Completed
Phase	Early Phase 1
Study type	Interventional; randomized, parallel, masking: double, prevention
Enrollment	62 (Actual)
Sponsor	Assiut University (Other)
Conditions	Breast Cancer
Interventions	Mirtazapine 30 MG, Placebo (Drug)
Dates	start 2024-03-01, primary completion 2025-12-10, completion 2025-12-20, first posted 2024-07-12, last updated 2026-01-22
Locations	1 site in Egypt

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Mirtazapine group	Active comparator	Drug: Mirtazapine 30 MG	patients will receive orally the night before surgery the study medication and daily up to two weeks after: Mirtazapine group: Mirtazapine 30 mg tablet
placebo group	Placebo comparator	Drug: Placebo	patients will receive orally the night before surgery the study medication and daily up to two weeks after: placebo tablet

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

+Outcome measures

Primary outcomes

The cumulative postoperative 24 h morphine consumption [24 hours]

Secondary outcomes

The visual analogue score of pain intensity [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.
The quality of recovery-40 questionnaire [24 hours]: 1 means very poor recover and 40 very good recovery
Assessment of sedation level [24 hours]: Assessment of sedation level by the Modiﬁed Ramsay Sedation score
Assessment of chronic pain [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.
Depression score [6 months]: Depression score by the Patient Health Questionnaire(PHQ9)

+Eligibility

Sex: Female, ages: 20 Years to 70 Years

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

+Locations (1)

Facility	City	Country	Status
south Egypt Cancer Institute Assiut University	Asyut	Egypt