A clinical trial to study the analgesic effect of two drugs inj levobupivacaine by epidural method and inj tramadol by intravenous method for labour pain relief.
- Conditions
- Complication of anesthesia duringlabor and delivery, unspecified, (2) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,
- Registration Number
- CTRI/2025/04/084763
- Lead Sponsor
- Pt JNM Medical College Raipur CG
- Brief Summary
This is a randomised Interventional study comparing epidural levobupivacaine versus IV tramadol in terms of analgesic efficacy during labour. Parturients requesting for epidural or iv analgesia will enroll with a sample size of 86(43 in each group). Primary outcome will be maternal analgesia using VAS Score. secondary outcomes will be duration of labour, mode of delivery, neonatal outcome, and complication if any. Monitoring of vital signs(BP.PR.SPO2.FHR) will be done hourly until delivery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 86
Pregnant women with singleton cephalic pregnancy requesting for labour analgesia at more than or equal to 37 weeks of gestation in active phase of labour .
contraindication to vaginal delivery contraindication to epidural allergy to the drugs used preterm pregnancy medical complications in pregnancy fetal distress.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maternal Analgesia using VAS score BP,PR, SPO2, FHR, VAS recorded initially in 15 min then after 1hourly till delivery
- Secondary Outcome Measures
Name Time Method neonatal outcome APGAR at 1 min and 5 min after birth duration of labour after delivery maternal satisfaction using likert scale at the end of procedure side effects and complications at the end of procedure mode of delivery at the time if delivery
Trial Locations
- Locations (1)
Dr Bhim Rao Ambedkar Memorial hospital, Raipur, Chhattisgarh
🇮🇳Raipur, CHHATTISGARH, India
Dr Bhim Rao Ambedkar Memorial hospital, Raipur, Chhattisgarh🇮🇳Raipur, CHHATTISGARH, IndiaDr Rashi MandhaniPrincipal investigator07089533130rashimandhani12345@gmail.com