Mirtazapine for Acute and Chronic Post Mastectomy Pain

NCT06499090 | Completed Early Phase 1

• 1 other identifier: mirtazapine for post mastectoy
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The cumulative postoperative 24 h morphine consumption

  24 hours

Secondary Outcomes (5)

• The visual analogue score of pain intensity

  24 hours

• The quality of recovery-40 questionnaire

  24 hours

• Assessment of sedation level

  24 hours

• Assessment of chronic pain

  6 months

• Depression score

  6 months

Study Arms (2)

Mirtazapine group

ACTIVE COMPARATOR

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

Drug: Mirtazapine 30 MG

placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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

Mirtazapine group

Placebo DRUG

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

placebo group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

south Egypt Cancer Institute Assiut University

Asyut, Egypt

Location

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: July 12, 2024
• Study Start: March 1, 2024
• Primary Completion: December 10, 2025
• Study Completion: December 20, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

EG (1)