Melatonin on Post Operative Pain After CS

Benha University60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Pain Management Pain After Surgery Cesarean Section Pain

Interventions

Melatonin 5 mgDRUG

Group I: (5 mg melatonin): Participants will receive 5 mg of oral melatonin 1 hours before the cesarean section.

Melatonin 10 mgDRUG

Group II: (10 mg melatonin): Participants will receive 10 mg of oral melatonin 1 hours before the cesarean section.

PlaceboDRUG

Group III: (Placebo): Participants will receive an identical placebo tablet 1 hours before the cesarean section.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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).

Locations (1)

Benha University Hospital

Banhā, Egypt

Outcomes

Primary Outcomes

Postoperative pain intensity measured using the VAS (Visual Analogue Scale)

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

Time frame: 2, 6, 12, and 24 hours post-surgery.

Secondary Outcomes

first rescue analgesia

Time to first request for analgesia postoperatively

Time frame: the first 24 hours post operative

Total opioid consumption

amount of opioid requested by the patient

Time frame: the first 24 hours post operative

Incidence of adverse effects

such as nausea, vomiting, headache, dizziness, sedation

Time frame: first 24 hours post operative

Time to first ambulation post-surgery

first movement by the patient

Time frame: first 24 hours post operative

Data from ClinicalTrials.gov

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