Analgesic Effect of Melatonin and Vitamin C Administration, Alone or In Combination in Major Abdominal Surgery. - Trial NCT06374771
Access comprehensive clinical trial information for NCT06374771 through Pure Global AI's free database. This phase not specified trial is sponsored by Cairo University and is currently Not yet recruiting. The study focuses on Postoperative Pain. Target enrollment is 60 participants.
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Study Focus
Sponsor & Location
Cairo University
Timeline & Enrollment
N/A
Apr 27, 2024
Jul 10, 2024
Primary Outcome
Total morphine consumption
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06374771
Non-Device Trial

