The trial assesses the efficacy of continuous epidural infusion of ropivacaine 0.125% and 0.2% mixed with fentanyl for prenatal patients undergoing active labour pain management.
- Conditions
- Health Condition 1: -
- Registration Number
- CTRI/2024/07/070837
- Lead Sponsor
- Priti Mourya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Singleton pregnancy at term (=37 weeks of
gestation) with vertex presentation.
2. Maternal age should be between 19 and 35 years.
Because according to child marriage act the age
of marriage for girls is 18 years and age =35
years is very advanced maternal age with
complicated outcomes like stillbirth, preterm
birth, perinatal death, GDM, gestational
hypertension and preeclampsia.
3. Informed consent provided by the participant.
4. Desire for epidural analgesia for pain
management.
5. Ability to understand and comply with the study
procedures.
1. Refusal to provide informed consent.
2. Twin pregnancy.
3. Breech presentation.
4. Pregnancy with antepartum haemorrhage.
5. History of adverse reactions to local
anaesthetics or opioids.
6.Medical contraindications to epidural
analgesia like increased intracranial pressure,
local infection at the site of puncture,
haemorrhagic diathesis or
therapeutic anticoagulants.
8. Known foetal anomalies or distress
necessitating
immediate delivery.
9. History of drug abuse.
10. Bleeding disorders.
11. Decreased platelet counts.
12. Spinal column deformities.
13. History of spine surgery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain Relief Efficacy: The primary outcome will assess the effectiveness of the analgesic regimens by comparing the degree of pain relief achieved by labouring mothers in Group A (Ropivacaine 0.125% with Fentanyl) and Group B (Ropivacaine 0.2% with Fentanyl). Pain relief will be evaluated using a visual analogue scale (VAS) or other standardized pain assessment tools.Timepoint: 24 months
- Secondary Outcome Measures
Name Time Method 1.Analgesic Consumption: The total amount of analgesic agents used by participants in each group will be recorded, including the volume of ropivacaine and the amount of fentanyl administered. <br/ ><br>2.Onset and Duration of Pain Relief: The time taken for pain relief to begin (onset) and the duration of effective pain relief for each analgesic regimen will be documented. <br/ ><br>3.Safety and Adverse Events: Adverse events associated with each analgesic regimen, such as hypotension, respiratory depression, or other complications, will be monitored and recorded. <br/ ><br>4.Neonatal Outcomes: The study will assess the impact of the analgesic regimens on neonatal outcomes, including Apgar scores and any immediate interventions required. <br/ ><br>5.Obstetric Outcomes: The effect of pain management choices on obstetric parameters will be analysed. This includes assessing progression, mode of delivery, and any interventions required during. <br/ ><br>Timepoint: 24 months