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: Obstetrics,

• Registration Number: CTRI/2023/06/054563
• Lead Sponsor: Pt B D Sharma University of Health Sciences PGIMS Rohtak Haryana

Brief Summary

In this study we are comparing the efficacy and safety of intrathecal hyperbaric ropivacaine with hyperbaric bupivacaine in patients undergoing caesarean section under spinal anesthesia. The present study is intended to compare the efficacy and safety of hyperbaric ropivacaine with hyperbaric bupivacaine.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-07
• Study Completion: 2024-01-03
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• 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	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.
Onset of sensory and motor block.	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.
Duration of sensory and motor block.	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	To compare the frequency of adverse effects like hypotension, bradycardia, nausea, vomiting in both the groups

Trial Locations

Locations (1)

Pt B.D. Sharma, PGIMS; 🇮🇳 Rohtak, HARYANA, India

Pt B.D. Sharma, PGIMS

🇮🇳Rohtak, HARYANA, India

Roopa Indora

Principal investigator

9630730039

roopaindora12@gmail.com