A randomised control trial comparing Ropivacaine, levobupivacaine and bupivacaine for spinal anaesthesia for caesarean section
- Conditions
- Term Pregnant Patients with uncomplicated pregnancy scheduled to for Caesarean Section
- Registration Number
- CTRI/2018/02/011711
- Lead Sponsor
- ESICPostgraduate Institute of Medical Sciences and Research
- Brief Summary
Aim of the study was to evaluate the spinal block characteristic of isobaric 0.5% levobupivacaine, isobaric 0.75% ropivacaine and its comparison with hyperbaric 0.5% bupivacaine for elective caesarean section. 100 term pregnant women with singleton pregnancy scheduled for elective caesarean section will be enrolled in this prospective double blind randomised trial. Written informed consent will be taken from all patients. Subarachnoid block will be given for caesarean section with 25 g spinal needle in L3-L4 with patients in left lateral position After confirming free flow of CSF, 2ml of test drug will be injected intrathecally.
Group B = 2 ml of 0.5% hyperbaric bupivacaine
Group R = 2 ml or 0.75 % isobaric ropivacaine
Group LB = 2 ml of 0.5 % isobaric levobupicaine
The following variables will be measured during intraoperatively: Sensory block and block onset times: modified bromage scale, Maximum sensory and motor block level achieved, Maternal Hemodynamic parameters ( 5 min interval), Neonatal Apgar Scores ( 1 and 5 mins), Quality of Anaesthesia (at the end of surgery), Quality of muscle relaxation, Sensory and motor block regression times, First analgesic request time, Side effects if any. Patients will be followed up on post-operative days 1 and 3 for any headache, backache, tingling or numbness in lower limbs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 100
Full term patients scheduled for caesarean section of ASA status1 and 2, age group of 18 to 40 years, body weight of 45 to 85 kg and height of 145 to165cm.
Parturients with hypersensitivity to local anesthetics, contraindications to neuraxial block, twin pregnancy, obstetric complications or fetal compromise were excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of motor block Duration of motor block
- Secondary Outcome Measures
Name Time Method Sensory and Motor block onset times Sensory and Motor block regression times
Trial Locations
- Locations (1)
ESI-Postgraduate Institute of Medical Sciences and Research
🇮🇳West, DELHI, India
ESI-Postgraduate Institute of Medical Sciences and Research🇮🇳West, DELHI, IndiaDivya SethiPrincipal investigator9891230700divyasth@gmail.com