Use of epidural colloid for comparison of low doses of intrathecally administered bupivacaine

Completed

Conditions: Booked to deliver by caesarean section

Registration Number: CTRI/2011/10/002037

Brief Summary: Epidural volume extension is a reliable technique that reduces the dose requirement of intrathecal bupivacaine, in combined spinal-epidural anaesthesia (CSEA).Though this technique results in a stable maternal haemodynamics, the chances of failed anaesthesia are high. This study aims to compare relative efficacy of three different low doses of intrathecal bupivacaine under CSEA with epidural volume extension for caesarean delivery.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 204

Inclusion Criteria

ASA Physical Status I or II, height 145-165 cm, body mass index of 25+/-10%, > 37 weeks of gestation, single nun-complicated pregnancy.

Exclusion Criteria

weight more than 100 kg, pregnancy-induced hypertension, end-organ disease, in active labour, emergency caesarean section any contraindication to regional anaesthesia.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of effective doses	During intraoperative period

Secondary Outcome Measures

Name	Time	Method
Degree of lower limb motor block	At 5 min intervals for the first 20 min after giving combined spinal epidural anaesthesia and at 10 min intervals thereafter.
Upper level of dermatomal sensory block	At 5 min intervals for the first 20 min after giving combined spinal epidural anaesthesia and at 10 min intervals thereafter.
Adequecy of muscle relaxation	By operating surgeon during intraoperative period
Complications	During intraoperative period
APGAR score	Of neonate at 1 and 5 min after birth
Need of epidural top-ups	During intraoperative period
Time to modified bromage score 6	Post operative period
Time to sensory regression to T10 level	Post operative period

Trial Locations

Locations (1): Department of Anaesthesia, Teerthankar Mahaveer medical college
🇮🇳
Moradabad, UTTAR PRADESH, India
Department of Anaesthesia, Teerthankar Mahaveer medical college
🇮🇳Moradabad, UTTAR PRADESH, India
Gaurav Jain
Principal investigator
9936871711
gauravhld@gmail.com