A clinical trial to compare the effects of two drugs, bupivacaine and ropivacaine in combination with fentanyl in labour pain relief

A PROSPECTIVE RANDOMIZED DOUBLE BLIND STUDY TO EVALUATE & COMPARE LABOUR ANALGESIA USING ROPIVACAINE 0.2% IN COMBINATION WITH FENTANYL 2µg/ml AND BUPIVACAINE 0.1% IN COMBINATION WITH FENTANYL 2µg/ml USING PATIENT CONTROLLED EPIDURAL ANALGESIA (PCEA) TECHNIQUE

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000150

Enrollment

100

Registered

2010-03-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Ropivacaine: 0.2% ropivacaine Control Intervention1: Bupivacaine: 0.1%

Eligibility

Inclusion criteria

Inclusion criteria: 1. Primigravida 2. ASA I & II physical status 3. The age group 18-30 yrs 4. Established labour and with cervical dilatation of 3-5cm

Exclusion criteria

Exclusion criteria: 1. ASA physical status of 3 or more. 2. Age less than 18yrs or more than 30 yrs. 3. Administration of parentral analgesics before epidural injection 4. Patients with local infection at the site of injection or bleeding disorders 5. Multiple gestation. 6. Inability to understand how to use PCEA pump.

Design outcomes

Primary

Measure	Time frame
Visual Analogue Scale -0 to 100 Bromage Scale - o-3 sensory assessment Pulse Blood pressure SpO2 Fetal heart rate Side effects Rescue top up doseTimepoint:	—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactSaba Ahad

sb.ahad@gmail.com01123981260

Outcome results