A Randomized, Double-blind Study to Compare the Efficacy of Intravenous Dexmedetomidine Infusion, Oral Gabapentin and Their Combination on Postoperative Analgesia in Cancer Patients Undergoing Modified Radical Mastectomy

ms-103-2021

Breast cancer is the most common malignant tumour among females with an incidence of about 2.1 million women every year.Nearly about 40-60% of breast surgery patients develop severe acute postoperative pain.⁴ Opioids are the current best standard drugs for postoperative pain relief, however, exposure to large doses of opioids leads to multiple side effects like prolonged sedation, respiratory depression, nausea, and vomiting.We are comparing two different drugs and their combination for perioperative analgesia for MRM. This work is a comparative study that aims to compare the analgesic effects of perioperative IV infusion of dexmedetomidine, preoperative oral gabapentin, and their combination in patients undergoing modified radical mastectomy surgery regarding the time of first rescue analgesia, postoperative morphine consumption, and possible complications.

2021-01-01

2022-02-01

2022-07-01

Completed

90

Inclusion Criteria: * ● Female physical status ASA I, II. * Body mass index (BMI): 20 kg/m2- 40 kg/m2. * A patient undergoing modified radical mastectomy under general anaesthesia. Exclusion Criteria: * ● Patient refusal. * Known sensitivity or contraindication to study drugs (e.g.: dexmedetomidine, gabapentin, or morphine ). * History of psychological disorders, chronic pain, and/or sympathetic disorders. * Patients receiving medications that are considered to result in tolerance to opioids as those who are receiving medications for cancer pain (e.g. tramadol and hydromorphone). * Significant liver insufficiency (liver enzymes more than two folds or severe liver cirrhosis) or renal insufficiency (plasma creatinine more than 1.5 mg/dl). * Severe respiratory disorders (e.g. Chronic obstructive pulmonary disease, Bronchial asthma), or cardiac disorders (e.g. ischemic heart disease, regional motion wall abnormality, EF\< 50%). * Pregnancy.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Both patients and Investigator for postoperative pain will be blinded:\n\n* Group 1(D): (n=30) Patients will receive oral placebo starch capsules 1 hour preoperatively and intraoperative intravenous infusion of dexmedetomidine with general anaesthesia.\n* Group 2(G): (n=30) Patients will receive oral gabapentin capsules for 1 hour preoperatively and intraoperative intravenous saline infusion with general anaesthesia.\n* Group 3(DG): (n=30) Patients will receive oral gabapentin capsules for 1 hour preoperatively and intraoperative intravenous infusion of dexmedetomidine with general anaesthesia.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}

2024-04-09