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.

Randomized Controlled Trail Comparing Ropivacaine 0.125% and Ropivacaine 0.2% in Conjunction With Fentanyl For Continuous Epidural Infusion In Antenatal Patients Experiencing Active Labor: An Assessment of Labor Pain Management. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070837

Enrollment

Registered

2024-07-18

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: -

Interventions

Intervention1: Adequate analgesia: GROUP A: This group will receive the 12 ml (7)of Ropivacaine 0.125% with 2µg/ml fentanyl via continuous epidural infusion till delivery. Control Intervention1: Adequ

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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. 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. 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. 4. Neonatal Outcomes: The study will assess the impact of the analgesic regimens on neonatal outcomes, including Apgar scores and any immediate interventions required. 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. Timepoint: 24 months	—

Measure

Time frame

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. 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. 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. 4. Neonatal Outcomes: The study will assess the impact of the analgesic regimens on neonatal outcomes, including Apgar scores and any immediate interventions required. 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. Timepoint: 24 months

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Countries

India

Contacts

Public ContactDr Avinash Prakash

All India Institute of Medical Sciences, Nagpur

dravinash@aiimsnagpur.edu.in9999596845

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026