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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
62
patients will receive orally the night before surgery the study medication and daily up to two weeks after Mirtazapine 30 mg tablet
patients will receive orally the night before surgery the study medication and daily up to two weeks after placebo tablet
south Egypt Cancer Institute Assiut University
Asyut, Egypt
The cumulative postoperative 24 h morphine consumption
Time frame: 24 hours
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 90°) measured at (0, 2,4,8,12,16 and 24h) postoperatively.
Time frame: 24 hours
The quality of recovery-40 questionnaire
1 means very poor recover and 40 very good recovery
Time frame: 24 hours
Assessment of sedation level
Assessment of sedation level by the Modified Ramsay Sedation score
Time frame: 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.
Time frame: 6 months
Depression score
Depression score by the Patient Health Questionnaire(PHQ9)
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.