Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Women aged 18-40 years
- Scheduled for elective cesarean section
- Ability to provide informed consent
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Actively Recruiting
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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