Pain Management, Pain After Surgery, Cesarean Section Pain
Conditions
Keywords
melatonin and pain after C.S
Brief 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
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.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity measured using the VAS (Visual Analogue Scale) | 2, 6, 12, and 24 hours post-surgery. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| first rescue analgesia | the first 24 hours post operative | Time to first request for analgesia postoperatively |
| Total opioid consumption | the first 24 hours post operative | amount of opioid requested by the patient |
| Incidence of adverse effects | first 24 hours post operative | such as nausea, vomiting, headache, dizziness, sedation |
| Time to first ambulation post-surgery | first 24 hours post operative | first movement by the patient |
Countries
Egypt
Outcome results
None listed