A clinical trial to compare efficacy of two drugs, Bupivacaine hydrochloride & Ropivacaine hydrochloride for extradural labour analgesia.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/12/005335
• Date of registration: 30-12-2014
• Prospective Registration: No
• Primary sponsor: Lokmanya tilak municipal medical college and general hospital
• Public title: A clinical trial to compare efficacy of two drugs, Bupivacaine hydrochloride & Ropivacaine hydrochloride for extradural labour analgesia.
• Scientific title: A Double blind comparison of combination of 0.1% Ropivacaine & Fentanyl to combination of 0.1% Bupivacaine & Fentanyl for extradural analgesia in labour.
• Date of first enrolment: 01-12-2009
• Target sample size: 60
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9566
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant and Investigator Blinded
• Phase: Phase 4

Countries of recruitment

India

Contacts

• Name: Dr Jyoti Magar
• Affiliation: Lokmanya Tilak Municipal Medical college and general hospital

• Name: KISHORI BAWDANE
• Affiliation: Lokmanya Tilak Municipal Medical college and general hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1. ASA grade I and II parturients

2. Consent for project

3. More than 36 weeks of gestation

4. Single live term fetus with vertex presentation

5. Uncomplicated active labour with cervical dilatation >= 3 cm


Exclusion criteria: 1. Unwilling mother

2. ASA > II

3. B.M.I. more than 30

4. Parturientâ??s height < 150cm

5. Age <18 years

6. Difficult intubation

7. Contraindication for epidural catheter placement

8. Complicated obstetric history

9. Sensitivity to study drug

10. Administration of IV analgesics within 1 hr of epidural request







Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: Epiduarl labour analgesia.: Epidural catheter was inserted under strict aseptic precautions when cervical dilatation reached more than 3 cm with active labour
The procedure was performed using 18 G Touhyâ??s needle with parturient in sitting position An 18 G multiorifice catheter with micro bacterial filter was placed in L3- L4 or L4-L5 inter vertebral space using loss of resistance technique & advancing the catheter tip 4cm cephald. The parturient was placed in supine position with left uterine displacement.
Control Intervention1: Bupivacaine hydrochloride 0.1%: Bupivacaine hydrochloride 0.1% with Fentanyl 2ug/cc for extradural labour analgesia in intermittent top up.
Initial 10 ml dose then 5 ml top up till VAS score less than 4.Then 5 ml top up whenever VAS score more than 3

Control Intervention2: Ropivacaine hydrochloride 0.1%: Ropivacaine hydrochloride 0.1% with Fentanyl 2ug/cc for extradural labour analgesia in intermittent top up.
Initial 10 ml dose then 5 ml top up till VAS score less than 4 Then 5ml top up whenever VAS score is more than 3

Primary Outcome(s)

Pain relief on Visual analogue score 0 to 10

Motor block assesed by Bromage score

Dose requirement of Bupivacaine and Ropivacaine and Fentanyl

Incidence of Instrumental deliveries.Timepoint: Pain score (VAS)and Motor block and requirement of drugs all at the begining of labour and during labour and at the end of labour

Instrumental deliveries at the end of labour.

Secondary Outcome(s)

Maternal Haemodynamic stability

Neonatal outcome assessed by Virginia Apgar score

Duration of labour

onset of analgesia

Incidence of side effects

cost effectiveness



Timepoint: At the begining of labour and during labour and at the end of labour.

Secondary ID(s)

NIL

Source(s) of Monetary Support

Lokmanya Tilak Municipal Medical college and general hospital Sion Mumbai 400022.

Ethics review

Status: Approved
Approval date: 30/11/2009
Contact:

Lokmanya tilak municipal medical college and Lokmanya tilak municipal general hospital staff and research society (estd.1967) Bombay Public Trust Act Reg.no.F/1669 of 21-9-1968.