The Effect of Preoperative Oral Melatonin on Postoperative Pain Control After Cesarean Section: A Dose Comparison Study
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Benha University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Postoperative pain intensity measured using the VAS (Visual Analogue Scale)
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts 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).
Arms & Interventions
Group III: (Placebo)
Intervention: Placebo (Drug)
Group I: (5 mg melatonin)
Intervention: Melatonin 5 mg (Drug)
Group II: (10 mg melatonin)
Intervention: Melatonin 10 mg (Drug)
Outcomes
Primary Outcomes
Postoperative pain intensity measured using the VAS (Visual Analogue Scale)
Time Frame: 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 Outcomes
- first rescue analgesia(the first 24 hours post operative)
- Total opioid consumption(the first 24 hours post operative)
- Incidence of adverse effects(first 24 hours post operative)
- Time to first ambulation post-surgery(first 24 hours post operative)
Investigators
Taghreed Elshahat Sakr
lecturer of anesthesia
Benha University