Melatonin on Post Operative Pain After CS

Benha University

Status: Enrolling

Conditions: Pain Management; Cesarean Section Pain; Pain After Surgery

Treatments: Drug: Melatonin 10 mg; Drug: Melatonin 5 mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07380568

RC.3.9.2025

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Group I: (5 mg melatonin)

Active Comparator group

Treatment:

Drug: Melatonin 5 mg

Group II: (10 mg melatonin)

Active Comparator group

Treatment:

Drug: Melatonin 10 mg

Group III: (Placebo)

Placebo Comparator group

Treatment:

Drug: Placebo