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Melatonin on Post Operative Pain After CS

ConditionsPain ManagementPain After SurgeryCesarean Section Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorBenha University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- Women aged 18-40 years.

Scheduled for elective cesarean section.

Ability to provide informed consent.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Group I: (5 mg melatonin)Active comparator 1 intervention
Group B: Group II: (10 mg melatonin)Active comparator 1 intervention
Group C: Group III: (Placebo)Placebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Benha University

Lead sponsor

Source ClinicalTrials.gov
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