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

Comparison of interleukins in parturients with combined spinal epidural versus epidural undergoing labour analgesia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/049668

Enrollment

Registered

2023-02-13

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

None listed

Interventions

Intervention1: Labour analgesia with combined spinal epidural: With 18G Tuohy’s needle, epidural space will be reached using loss of resistance to air technique. A 27G spinal needle will be used to en

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. T2-full cervix dilatation. T3- umblical cord blood.	—

Secondary

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

Countries

India

Contacts

Public ContactDr Sukanya Mitra

Government Medical College and Hospital, Sector 32, Chandigarh

drsmitra12@yahoo.com9646121521

Outcome results