CClinicalTrials.gg
CompletedNCT07380568CSUpdated Jul 14, 2026

Melatonin on Post Operative Pain After CS

An interventional study of Melatonin 5 mg and Melatonin 10 mg in Pain Management, Pain After Surgery and Cesarean Section Pain, sponsored by Benha University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Benha University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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

02

Conditions studied

  • Pain Management
  • Pain After Surgery
  • Cesarean Section Pain

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Keywords

  • melatonin and pain after C.S
03

In context

Agnosia

1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.

This study's enrollment of 60 is below the median of 78 across 1,024 interventional studies indexed under Agnosia.

Browse Agnosia studies →

Lead sponsor

Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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).
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Group I: (5 mg melatonin)

    Drug: Melatonin 5 mg

  • Active comparator
    Group II: (10 mg melatonin)

    Drug: Melatonin 10 mg

  • Placebo comparator
    Group III: (Placebo)

    Drug: Placebo

Interventions

  • DrugMelatonin 5 mg

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

  • DrugMelatonin 10 mg

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

  • DrugPlacebo

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

06

What researchers measure

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

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

Secondary outcomes

  1. first rescue analgesia

    Time to first request for analgesia postoperatively

    Time frame: the first 24 hours post operative

  2. Total opioid consumption

    amount of opioid requested by the patient

    Time frame: the first 24 hours post operative

  3. Incidence of adverse effects

    such as nausea, vomiting, headache, dizziness, sedation

    Time frame: first 24 hours post operative

  4. Time to first ambulation post-surgery

    first movement by the patient

    Time frame: first 24 hours post operative

07

Study locations

1 site
  • Benha University Hospital
    Banhā, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07380568
Lead sponsor
Benha University
Responsible party
Taghreed Elshahat Sakr (lecturer of anesthesia, Benha University) — Principal investigator
First posted
Feb 2, 2026
Start date
Oct 10, 2025
Primary completion
Mar 1, 2026
Completion
Apr 1, 2026
Last update
Jul 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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