Melatonin on Post Operative Pain After CS (CS)

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

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

Study Overview

• Status: Recruiting
• Conditions: Pain Management; Cesarean Section Pain; Pain After Surgery
• Intervention / Treatment: Drug: Melatonin 5 mg; Drug: Melatonin 10 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Banhā, Egypt
    • Recruiting
    • Benha University Hospital
    • Contact: Taghreed Sakr, MD degree of anesthesia; Phone Number: 00201112723187; Email: taghreed.sakr@fmed.bu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I: (5 mg melatonin)	Drug: Melatonin 5 mg; Group I: (5 mg melatonin): Participants will receive 5 mg of oral melatonin 1 hours before the cesarean section.
Active Comparator: Group II: (10 mg melatonin)	Drug: Melatonin 10 mg; Group II: (10 mg melatonin): Participants will receive 10 mg of oral melatonin 1 hours before the cesarean section.
Placebo Comparator: Group III: (Placebo)	Drug: Placebo; Group III: (Placebo): Participants will receive an identical placebo tablet 1 hours before the cesarean section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
first rescue analgesia	Time to first request for analgesia postoperatively	the first 24 hours post operative
Total opioid consumption	amount of opioid requested by the patient	the first 24 hours post operative
Incidence of adverse effects	such as nausea, vomiting, headache, dizziness, sedation	first 24 hours post operative
Time to first ambulation post-surgery	first movement by the patient	first 24 hours post operative

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: December 28, 2025
• First Submitted That Met QC Criteria: January 24, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 24, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: melatonin and pain after C.S
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Tryptamines; Melatonin
• Other Study ID Numbers: RC.3.9.2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No