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

NCT06374771 | Not Yet Recruiting

• 1 other identifier: MD-15-2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  mg

  The 1st 24 postoperative hours

Secondary Outcomes (8)

• Numeric Rating Scale

  5 minutes after extubation, 30 minutes, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, one month and three months

• Richmond Agitation Sedation Scale

  5 minutes after extubation, 30 minutes, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours

• Time to first analgesic request

  from the time of end of surgery till the first analgesic requirement during the 24 hours postoperative

• chronic post-surgical pain

  3 months

• patient satisfaction using Likert three-point scale

  24 hours, 48 hours, 72 hours, 96 hours, one month and three months postoperative

Study Arms (3)

Melatonin (M group)

ACTIVE COMPARATOR

Two hours before surgery, patients will receive 10 mg of melatonin (Melatonin 10 mg - Puritan's Pride premium company) orally which will be continued once daily for 3 days postoperative at the same time as the first administration.

Drug: Melatonin 10 MG

Vitamin C (V group)

ACTIVE COMPARATOR

Two hours before surgery, patients will receive 1gm of vitamin C (Sanso C 1000 mg - AUG pharma company) orally which will be continued once daily for 3 days postoperative at the same time as the first administration.

Drug: Vitamin C

Melatonin and Vitamin C (VM group)

ACTIVE COMPARATOR

Two hours before surgery, patients will receive 10mg of melatonin and 1gm of vitamin C orally which will be continued once daily for 3 days postoperative at the same time as the first administration.

Drug: Melatonin 10 MG; Drug: Vitamin C

Interventions

Melatonin 10 MG DRUG

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

Also known as: (Melatonin 10 mg - Puritan's Pride premium company)

Melatonin (M group); Melatonin and Vitamin C (VM group)

Vitamin C DRUG

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

Also known as: (Sanso C 1000 mg - AUG pharma company)

Melatonin and Vitamin C (VM group); Vitamin C (V group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I -II
• Expected time of operation 3-5 hours

You may not qualify if:

• BMI \> 35 kg/m2
• Presence of psychiatric or mental disorders.
• Chronic pain syndromes (neuropathic pain, post-herpetic neuralgia, Complex regional pain syndrome)
• Drug or alcohol abuse.
• Hepatic failure (Child class B- Child class C)
• Renal impairment (creatinine \> 2mg/dL or CKD on regular dialysis)
• History of any allergic reaction to the drugs used in the study.

Sponsors & Collaborators

• Cairo University: lead
• Theodor Bilharz Research Institute: collaborator

Study Sites (1)

Faculty of Medicine - Cairo University

Cairo, Manial, 11553, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Melatonin; Ascorbic Acid

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Waleed Hamimy, MD

  Professor of Anesthesiology

  STUDY CHAIR

Central Study Contacts

Amr K Abdelhakeem, MD

CONTACT

01004332993; amr.kamal@kasralainy.edu.eg

Khaled Sarhan, MD

CONTACT

01020067816; khaled.sarhan@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesia, intensive care medicine and Pain therapy

Study Record Dates

• First Submitted: April 14, 2024
• First Posted: April 19, 2024
• Study Start: April 27, 2024
• Primary Completion: June 27, 2024
• Study Completion: July 10, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

EG (1)