Evaluation of the Efficacy of Perioperative Administration of Tianeptine Versus Pregabalin on Acute and Chronic Post Mastectomy Pain After Breast Cancer Surgery. A Double-Blinded Randomized Controlled Trial.

AP2305.501.039

Breast cancer is the most common malignancy among females. Nearly 40% of breast surgery patients experience moderate to severe acute postoperative pain, with severe pain persisting for more than 6 months in almost 20-50% of patients (post mastectomy pain syndrome) which is defined according to International Association for the Study of Pain (IASP) as pain which persists more than 3 months after mastectomy/lumpectomy affecting the anterior thorax, axilla, and/or medial upper arm. Different pharmacological tools have been in use for either prevention or treatment of such refractory pain syndrome with variable efficacy. The aim of this study is to assess the efficacy of the perioperative use of Pregabalin versus Tianeptine on the emergence of PMPS in female patients undergoing MRM for breast cancer.

2023-06-21

2024-07-01

2024-07-01

Recruiting

90

Inclusion Criteria: 1. Breast cancer female patients. 2. ASA class II and III. 3. Age ≥ 18 and ≤ 60 Years. 4. Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2. 5. Type of surgery; elective breast cancer surgery (either modified radical mastectomy or conservative breast surgery) combined with axillary dissection. Exclusion Criteria: 1. Patient refusal. 2. Age \<18 years or \>65 years. 3. BMI \<20 kg/m2 and \>35 kg/m2. 4. Known sensitivity or contraindication to drugs used in the study (Pregabalin , Tianeptine , NSAIDs, or morphine ). 5. History of psychiatric disorders or history of major depression. 6. History of chronic pain that necessitates morphine at a daily dose of 30 mg or more (or equivalent opioids). 7. history of gapabentenoids or antidepressant intake in the preceding three months. 8. Major medical conditions. 9. Pregnancy or lactation.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

2024-04-22