Melatonin on Post Operative Pain After CS

NCT07380568 | Recruiting

• 1 other identifier: RC.3.9.2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if melatonin will decrease pain after C.S. The main questions it aims to answer are: Does melatonin lower the number of times participants need to use a rescue analgesia? What medical problems do participants have when taking melatonin? Researchers will compare different doses of melatonin to see the ideal dose to decrease pain after C.S. Participants will: Take melatonin 30 min before C.S and will be observed for 24 hours for pain and consumption of other analgesia

Conditions

Pain Management; Pain After Surgery; Cesarean Section Pain

Keywords

melatonin and pain after C.S

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity measured using the VAS (Visual Analogue Scale)

  it typically consists of a 100 mm straight line with descriptive anchors at each end representing the extremes of the sensation (for example, "no pain" at one end and "the most severe pain imaginable" at the other). Respondents indicate their experience by marking a point on the line, and the distance from the lower anchor is measured and recorded as a continuous variable

  2, 6, 12, and 24 hours post-surgery.

Secondary Outcomes (4)

• first rescue analgesia

  the first 24 hours post operative

• Total opioid consumption

  the first 24 hours post operative

• Incidence of adverse effects

  first 24 hours post operative

• Time to first ambulation post-surgery

  first 24 hours post operative

Study Arms (3)

Group I: (5 mg melatonin)

ACTIVE COMPARATOR

Drug: Melatonin 5 mg

Group II: (10 mg melatonin)

ACTIVE COMPARATOR

Drug: Melatonin 10 mg

Group III: (Placebo)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Melatonin 5 mg DRUG

Group I: (5 mg melatonin): Participants will receive 5 mg of oral melatonin 1 hours before the cesarean section.

Group I: (5 mg melatonin)

Melatonin 10 mg DRUG

Group II: (10 mg melatonin): Participants will receive 10 mg of oral melatonin 1 hours before the cesarean section.

Group II: (10 mg melatonin)

Placebo DRUG

Group III: (Placebo): Participants will receive an identical placebo tablet 1 hours before the cesarean section.

Group III: (Placebo)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Women aged 18-40 years.
• Scheduled for elective cesarean section.
• Ability to provide informed consent.

You may not qualify if:

• Known hypersensitivity to melatonin or opioids
• Chronic use of analgesics, sedatives, or antidepressants.
• History of sleep disorders or psychiatric illness.
• Complicated pregnancies (e.g., preeclampsia, gestational diabetes).
• Body mass index (BMI) \> 35 kg/m².
• Emergency cesarean sections.
• Severe systemic diseases (e.g., liver or kidney dysfunction).

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Banhā, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: February 2, 2026
• Study Start: October 10, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)