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Analgesic Effect of Melatonin and Vitamin C Administration, Alone or In Combination in Major Abdominal Surgery. - Trial NCT06374771

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NCT06374771
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Trial Details
ClinicalTrials.gov โ€ข NCT06374771
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Analgesic Effect of Melatonin and Vitamin C Administration, Alone or In Combination in Major Abdominal Surgery.
Analgesic Effect of Melatonin and Vitamin C Administration, Alone or In Combination in Major Abdominal Surgery. A Randomized Double-blind Study

Study Focus

Postoperative Pain

Melatonin 10 MG

Interventional

drug

Sponsor & Location

Cairo University

Cairo, Egypt

Timeline & Enrollment

N/A

Apr 27, 2024

Jul 10, 2024

60 participants

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

Acute pain
Postoperative intestinal obstruction
Pain, unspecified
During surgical operation
During surgical operation

Data Source

ClinicalTrials.gov

NCT06374771

Non-Device Trial