Painless delivery

Phase 1

• Conditions: Health Condition 1: null- ASA grade I and II

• Registration Number: CTRI/2018/06/014565
• Lead Sponsor: Govt Medical College Amritsar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Pregnant women with singleton pregnancy, term gestation, cephalic presentation, in active stage of labour, having full term live foetus.

Primigravida, without any obstetric complications and requesting for pain relief

Having regular contractions at least once every 5 minutes

Cervical dilation of 3-4 cm

ASA Grade I and II

Age 20-35 years

Height > 145 cm

BMI 18-25 (weight/height2)

Exclusion Criteria

1. Patientâ??s refusal

2. ASA Grade III and IV

3. Coagulation disorders and Bleeding disorders

4. Raised intracranial tension

5. Hypersensitivity to the study drugs

6. Cephalopelvic disproportion (CPD)

7. Pre-term gestation (gestational age < 35 weeks)

8. Any Vertebral column deformity and spine surgery

9. Any sign of infection at puncture site or sepsis

10. Contraindication for epidural catheter placement

11. Non reassuring NST

12. Foetal weight <2500 gm or >4500 gm

13. Multiple pregnancy and malpresentation

14. History of drug abuse and any obstetric complications

15. History of cardiac arrhythmias or labile hypertension

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Onset of sensory and motor block <br/ ><br>Duration of sensory and motor block <br/ ><br>Timepoint: Onset of sensory and motor block <br/ ><br>Duration of sensory and motor block <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Maternal and foetal outcome <br/ ><br>Maternal satisfaction score <br/ ><br>Side effects and complications <br/ ><br>Timepoint: 48 hours