MedTrace Logo

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

NCT06374771 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-04-19

No results posted yet for this study

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.

Conditions

  • Postoperative Pain

Interventions

DRUG

Melatonin 10 MG

10 mg of Melatonin will be given orally pre and post-operative

DRUG

Vitamin C

1 gm of Vitamin C will be given orally pre and post-operative

Sponsors & Collaborators

  • Theodor Bilharz Research Institute

    collaborator OTHER

  • Cairo University

    lead OTHER

Principal Investigators

  • Waleed Hamimy, MD · Professor of Anesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-27
Primary Completion
2024-06-27
Completion
2024-07-10

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06374771 on ClinicalTrials.gov