Does local anaesthetic drug 0.08% levobupivacaine reduce the rate of instrumental vaginal delivery compared to another local anaesthetic drug 0.1% ropivacaine

Completed

• Conditions: pregnant patients

• Registration Number: CTRI/2018/01/011236
• Lead Sponsor: Mahatma Gandhi Medical College and Research Institute

Brief Summary

this study was aimed to assess the efficacy of two local anaesthetic agents ( levibupivacaine and ropivacaine) for labour analgesia. We aimed to assess the mode of delivery, analegesia score, patient satisfaction score and complications, if any.

it is a double blinded study and randomization was done by computer generated number, ealed envelope technique.

epidural catheter was placed at the first stage of labour and epidural activated with the repective study drug.

patient was monitored for analgesia, motor blockade and hemodynamics.

study ended with delivery of baby.

Results

Mode Of Delivery**:** In Levobupivacaine (n=35),4 parturients underwent Cesarian section (11.4%) and in Ropivacaine group(n=35), 13 underwent Cesarian section (37.1%) which was statisticallysignificant (p=0.012)

Instrumentation Among Vaginal Delivery : In Levobupivacaine Group, out of the 31Vaginal deliveries, two had Instrumentation (6.45%). In Ropivacaine group, outof the 22 Vaginal deliveries, one underwent Instrumentation (4.54%) which wasstatistically not significant (p=0.739)

Hemodynamics , baby apgar, maternalsatisfaction were comparable in both groups with no side effects

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-12
• Study Completion: 2017-10-07
• Last Update Posted: 2018-09-01

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• 1. Primigravida with singleton pregnancy 2) Willing to involve in this study 3) Age between 18years to 30years.
• 4. Categorized under ASA PS I & II.

Exclusion Criteria

1)Patient refusal 2)High risk pregnancy 3)Primigravida with CPD 4)With fetal anomaly 5)Allergic to local anaesthetics 6)Injection site infection 7)Spine abnormalities 8)Significant coagulopathies.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mode of delivery	time of delivery

Secondary Outcome Measures

Name	Time	Method
1. Hemodynamic ( SpO2, MAP, PR, FHR)	2. Foetal outcome

Trial Locations

Locations (1)

Mahatma Gandhi Medical College and Research Institute; 🇮🇳 Pondicherry, PONDICHERRY, India

Mahatma Gandhi Medical College and Research Institute

🇮🇳Pondicherry, PONDICHERRY, India

surya R

Principal investigator

08489177972

dr.anniej@yahoo.com