To compare levels of biochemical protein in pregnant female with two techniques of nerve blockade undergoing painless labour

Phase 4

Registration Number: CTRI/2023/02/049668

Lead Sponsor: Department of Anaesthesia and Intensive Care

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

1.American Society of Anaesthesiologists (ASA) grade I and II

2.Age >18 years

3.Primigravida

4.Single gestation

5.Cephalic presentation at = 36 weeks of gestation

6.In true labour (cervical dilation = 5 cm)

7.Baseline pain score > 30 (on a 0-100 VAS)

8.Able to use PCEA pump

9.Requesting epidural analgesia for labour

Exclusion Criteria

1.Refusal by parturient

2.Obesity (weight >100kg)

3.Parturient who had received parenteral opioids in the last 4 hours

4.Systemic and local sepsis

5.Deranged coagulation profile

6.Parturients having multiple pregnancies

7.Obstetric complications (e.g., premature rupture of amniotic membranes, premature labour, eclampsia, antepartum hemorrhage, chorioamionitis, HELLP syndrome)

8.Noncephalic presentations

9.Allergy to study drugs, i.e., levobupivacaine, fentanyl.

10.Patient with history of immunosuppresion

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of il 1 beta/ il 10 , il 6 in parturient with combined spinal epidural versus epidural undergoing labour analgesia.Timepoint: T1- before epidural analgesia. <br/ ><br>T2-full cervix dilatation. <br/ ><br>T3- umblical cord blood.

Secondary Outcome Measures

Name	Time	Method
Maternal fever, <br/ ><br>Maternal satisfaction <br/ ><br>Pain score (VAS), <br/ ><br>Levels of IL–1beta, IL-10, IL-6, Sensory and motor block characteristics, Hemodynamic parameters of mother, <br/ ><br>Foetal heart rate, <br/ ><br>Duration of second stage of labour, Mode of delivery, <br/ ><br>Apgar scores at 1,2 and 5 min, <br/ ><br>Other adverse effects if any <br/ ><br> <br/ ><br>Timepoint: during duration of labour and follow up upto 48 <br/ ><br>hours.