Analgesic Effect of Melatonin and Vitamin C Administration, Alone or In Combination in Major Abdominal Surgery. A Randomized Double-blind Study

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2024
The goal of this clinical trial is to compare the analgesic effect of melatonin, and vitamin C and their combination in patients aged 18-60 years old who will undergo major abdominal surgery with mid-line incision within an expected time of surgery from 3 to 5 hours e.g. radical cystectomy, radical prostatectomy, colectomy, sigmoidectomy, splenectomy, and CBD exploration through mid-line incision. This study hypothesizes that using both vitamin C and melatonin together as adjuvants will cause: - More reduction in total morphine consumption in the first 24 hours postoperatively - More reduction of the incidence of chronic post-surgical pain, than using each adjuvant alone. Participants will be allocated into three equal groups: Melatonin (M group) and vitamin C (V group), and Melatonin and vitamin C (VM group). Two hours before surgery all patients will receive the study drugs orally and will be continued for 3 days postoperative at the same time of the first administration; 10mg of melatonin for M group (Melatonin 10 mg - Puritan's Pride premium company), 1gm of vitamin C for V group (Sanso C 1000 mg - AUG pharma company), and 10mg of melatonin and 1gm of vitamin C for VM group. Researchers will compare: - The effect of melatonin, vitamin C, and their combination on postoperative opioid consumption - The severity of postoperative pain, using the Numerical Rating Scale (NRS) - Patients' satisfaction with a three-point scale - The time of the first requirement for rescue analgesia - The effect on the incidence of chronic post-surgical pain.
Epistemonikos ID: b9cbc8beca5a655274b778509b36ccca6dc2e1d1
First added on: May 15, 2024