Clinical trial · Interventional
Mirtazapine for Acute and Chronic Post Mastectomy Pain
The Effect of Peri-operative Mirtazapine on Acute and Chronic Post Mastectomy Pain (Prospective Randomized Controlled Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mirtazapine 30 MG | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Mirtazapine group
- description
- patients will receive orally the night before surgery the study medication and daily up to two weeks after: Mirtazapine group: Mirtazapine 30 mg tablet
- interventionNames
- Drug: Mirtazapine 30 MG
- type
- PLACEBO_COMPARATOR
- label
- placebo group
- description
- patients will receive orally the night before surgery the study medication and daily up to two weeks after: placebo tablet
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- The cumulative postoperative 24 h morphine consumption
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available