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OpenTrials
Completed

NCT Number: NCT07380568

Melatonin on Post Operative Pain After CS

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

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Key information

Conditions

Pain Management Agnosia Cesarean Section Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain After Surgery Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Benha University Hospital

Banhā, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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).

Treatment and study plan

Melatonin 5 mg

Drug

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

Melatonin 10 MG

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: 2, 6, 12, and 24 hours post-surgery.

    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

Secondary outcomes

  1. first rescue analgesia

    Time frame: the first 24 hours post operative

    Time to first request for analgesia postoperatively

  2. Total opioid consumption

    Time frame: the first 24 hours post operative

    amount of opioid requested by the patient

  3. Incidence of adverse effects

    Time frame: first 24 hours post operative

    such as nausea, vomiting, headache, dizziness, sedation

  4. Time to first ambulation post-surgery

    Time frame: first 24 hours post operative

    first movement by the patient

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

The Effect of Preoperative Oral Melatonin on Postoperative Pain Control After Cesarean Section: A Dose Comparison Study

Acronym: CS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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