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Trial Title:
Mirtazapine for Acute and Chronic Post Mastectomy Pain
NCT ID:
NCT06499090
Condition:
Breast Cancer
Conditions: Official terms:
Mirtazapine
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Participant, Care Provider)
Intervention:
Intervention type:
Drug
Intervention name:
Mirtazapine 30 MG
Description:
patients will receive orally the night before surgery the study medication and daily up
to two weeks after Mirtazapine 30 mg tablet
Arm group label:
Mirtazapine group
Intervention type:
Drug
Intervention name:
Placebo
Description:
patients will receive orally the night before surgery the study medication and daily up
to two weeks after placebo tablet
Arm group label:
placebo group
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Minimum age:
20 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
south Egypt Cancer Institute Assiut University
Address:
City:
Assiut
Country:
Egypt
Start date:
July 2024
Completion date:
December 2027
Lead sponsor:
Agency:
Assiut University
Agency class:
Other
Source:
Assiut University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06499090
https://pubmed.ncbi.nlm.nih.gov/22342987/
