Comparative study of the efficacy and safety of intrathecal hyperbaric ropivacaine with hyperbaric bupivacaine in patients undergoing caesarean section under spinal anaesthesia
Phase 3
Completed
- Conditions
- Health Condition 1: 1- Obstetrics
- Registration Number
- CTRI/2023/06/054563
- Lead Sponsor
- Pt B D Sharma University of Health Sciences PGIMS Rohtak Haryana
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
Inclusion Criteria
Parturients between 20 to 35 years of age (American Society of Anaesthesiologists, ASA II) undergoing caesarean section under spinal anaesthesia
Exclusion Criteria
1Patient refusal
2 <18 years
3BMI > 35kg/m2
4Height < 5 feet
5Any contraindication to regional anesthesia
6Twin pregnancy
7Drug allergy to local anaesthetics/study drugs
8Refusal to give consent
9Conversion to general anesthesia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the two drugs in terms of <br/ ><br>Onset of sensory and motor block. <br/ ><br>Duration of sensory and motor block.Timepoint: The segmental level of sensory block will be assessed by loss of sensation to pin-prick at 2 minute intervals for first 15 minutes and thereafter at 15 minute intervals till regression to L5. The motor block will be evaluated at similar time intervals using modified Bromage scale.
- Secondary Outcome Measures
Name Time Method To compare the maximum level of sensory block achieved <br/ ><br>To compare the frequency of adverse effects like hypotension, bradycardia, nausea, vomiting in both the groupsTimepoint: Time taken to achieve maximal level of sensory block will be noted in both groups <br/ ><br>Adverse effects like hypotension, bradycardia, nausea, vomiting, arrythmias, any episode of desaturation(spo2 less than 90%)