The Efficacy of Tianeptine Versus Pregabalin on Acute and Chronic Post Mastectomy Pain After Breast Cancer Surgery.
Post-mastectomy Pain Syndrome
About this trial
This is an interventional supportive care trial for Post-mastectomy Pain Syndrome focused on measuring Breast cancer, Post mastectomy pain, chronic pain
Eligibility Criteria
Inclusion Criteria: Breast cancer female patients. ASA class II and III. Age ≥ 18 and ≤ 60 Years. Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2. Type of surgery; elective breast cancer surgery (either modified radical mastectomy or conservative breast surgery) combined with axillary dissection. Exclusion Criteria: Patient refusal. Age <18 years or >65 years. BMI <20 kg/m2 and >35 kg/m2. Known sensitivity or contraindication to drugs used in the study (Pregabalin , Tianeptine , NSAIDs, or morphine ). History of psychiatric disorders or history of major depression. History of chronic pain that necessitates morphine at a daily dose of 30 mg or more (or equivalent opioids). history of gapabentenoids or antidepressant intake in the preceding three months. Major medical conditions. Pregnancy or lactation.
Sites / Locations
- National Cancer Institute Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
pregabalin group (group P)
Tianeptine group (group T)
pregabalin group (group P) patients will receive pregabalin (Lyrica, Pfizer, NY) 50 mg with a sip of water one hour before induction of anesthesia and repeated every 8 hours for five days after surgery. The pregabalin capsules will be given to patients by nurses blinded to the study. Neither the researcher allocating the participants, nor the assessing person knew the decoding of the groups in its relation to the allocation sequence. Data will be collected by a junior pain resident blinded to the study protocol.
Tianeptine group (group T) patients will receive Tianeptine 12.5 mg (Stablon, Servier, France)with a sip of water one hour before induction of anesthesia and repeated every 8 hours for five days after surgery. The Tianeptine capsules will be given to patients by nurses blinded to the study. Neither the researcher allocating the participants, nor the assessing person knew the decoding of the groups in its relation to the allocation sequence. Data will be collected by a junior pain resident blinded to the study protocol.