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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| placebo group | Placebo Comparator | patients will receive orally the night before surgery the study medication and daily up to two weeks after: placebo tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The cumulative postoperative 24 h morphine consumption | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The visual analogue score of pain intensity | VAS score of pain intensity at rest and arm movement (abduction of the arm of the operated side up to 90Ā°) measured at (0, 2,4,8,12,16 and 24h) postoperatively. | 24 hours |
| The quality of recovery-40 questionnaire |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| south Egypt Cancer Institute Assiut University | Asyut | Egypt |
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| Label | URL |
|---|---|
| combination of mirtazapine and milnacipran augments the extracellular levels of monoamines in the rat brain. | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000078785 | Mirtazapine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | patients will receive orally the night before surgery the study medication and daily up to two weeks after placebo tablet |
|
1 means very poor recover and 40 very good recovery |
| 24 hours |
| Assessment of sedation level | Assessment of sedation level by the Modiļ¬ed Ramsay Sedation score | 24 hours |
| Assessment of chronic pain | 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. | 6 months |
| Depression score | Depression score by the Patient Health Questionnaire(PHQ9) | 6 months |
| D017437 |
| Skin and Connective Tissue Diseases |