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A Study to Compare the Efficacy And Safety Of Different Adjuncts To Local Anaesthetic For Labor Pain

A Randomised Clinical Trial To Compare The Efficacy And Safety Of Dexmedetomidine-Ropivacaine Versus Fentanyl-Ropivacaine For Epidural Labor Analgesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053707
Enrollment
68
Registered
2023-06-09
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: injection Dexmedetomidine IV: Group RD will be receiving Intravenous Dexmedetomidine used as adjuvant to local anaesthetics 0.1% Ropivacaine. Dose of dexmedetomidine is 0.5mcg/ml of 0.1

Sponsors

Shri B M Patil Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Primigravida with cephalic presentation ASA grade I and II Maternal age 19 to 35 years Term gestation more than or equal to 37 weeks Single fetus Cervical dilatation more than or equal to 4 cm

Exclusion criteria

Exclusion criteria: Hypotension/ Hypertension Obesity Endocrine disorders Fetal compromise Preterm gestation Coagulopathies Allergy to study agents Contraindications to epidural analgesia

Design outcomes

Primary

MeasureTime frame
To compare Dexmedetomidine and Fentanyl as adjuvants in epidural analgesia in terms of: The onset of epidural analgesia, duration of analgesia, rescue analgesic dose Visual Analog Scale(VAS) Maternal Vitals- Heart rate, Blood Pressure, Oxygen saturationTimepoint: Cervical dilatation from more than or equal to 4 cm to time of delivery

Secondary

MeasureTime frame
Ramsay Sedation Score APGAR score of the baby Maternal side effects- pruritis, hypotension, nausea, vomiting, shivering, respiratory depression, bradycradiaTimepoint: Time of Epidural analgesia to time of delivery of baby

Countries

India

Contacts

Public ContactRESHMA R S

Shri B M Patil Medical College

shivanandkarigar82@gmail.com9164319345

Outcome results

None listed

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