Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
ID07380568

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

Led by Benha University · Updated on 2026-02-02

60

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying if melatonin can reduce pain after cesarean section (C.S.) by comparing different doses. The main goals are to find out if melatonin lowers the need for additional pain relief and to observe any medical problems that might occur with its use. This study involves women undergoing elective cesarean sections and aims to identify the ideal melatonin dose for pain control. Participants will be randomly assigned to one of three groups: one receiving 5 mg of oral melatonin, another 10 mg of oral melatonin, and a third receiving a placebo. The assigned tablet is taken one hour before the cesarean section. The study uses a triple-blind design to compare these treatments. During the 24 hours after surgery, participants will be monitored for pain intensity using the Visual Analogue Scale (VAS) at 2, 6, 12, and 24 hours. Researchers will also track the first use of rescue pain medication, total opioid consumption, any adverse effects, and the time until participants first walk after surgery. This monitoring helps understand the pain control effect and safety of melatonin after cesarean section.

CONDITIONS

Brief Title

Melatonin on Post Operative Pain After CS

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18-40 years
  • Scheduled for elective cesarean section
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Known hypersensitivity to melatonin or opioids
  • Chronic use of analgesics, sedatives, or antidepressants
  • History of sleep disorders or psychiatric illness
  • Complicated pregnancies such as preeclampsia or gestational diabetes
  • Body mass index (BMI) greater than 35 kg/m²
  • Emergency cesarean sections
  • Severe systemic diseases like liver or kidney dysfunctions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of surgery

Participants receive a single dose of oral melatonin or placebo 1 hour before the cesarean section.

1 preoperative visit and hospital stay for surgery

Post-operative Follow-up

Duration - 24 hours post surgery

Participants are monitored for postoperative pain and recovery during the first 24 hours after surgery.

Pain assessments at 2, 6, 12, and 24 hours post surgery

Trial Site Locations

Total: 1 location

1

Benha University Hospital

Banhā, Egypt

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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