Mirtazapine for Acute and Chronic Post Mastectomy Pain

Early Phase 1

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Mirtazapine 30 MG; Drug: Placebo

• Registration Number: NCT06499090
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-06
• Study First Submitted QC: 2024-07-06
• Study First Posted: 2024-07-12
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Primary Completion: 2027-07
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The cumulative postoperative 24 h morphine consumption	24 hours

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

south Egypt Cancer Institute Assiut University; 🇪🇬 Assiut, Egypt