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Comparative study of the efficacy and safety of intrathecal hyperbaric ropivacaine with hyperbaric bupivacaine in patients undergoing caesarean section under spinal anaesthesia

Comparative evaluation of the efficacy and safty of intrathecal hyperbaric ropivacaine with hyperbaric bupivacaine in patients undergoing caesarean section under spinal anaesthesia - Not applicable

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054563
Enrollment
90
Registered
2023-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 1- Obstetrics

Interventions

Intervention1: Under all aseptic precautions subarachnoid block will be performed at L3-L4 or L4-L5 interspace with patient in sitting position, using 2ml of 0.75% hyperbaric ropivacaine: Spinal anaes

Sponsors

Pt B D Sharma University of Health Sciences PGIMS Rohtak Haryana
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Parturients between 20 to 35 years of age (American Society of Anaesthesiologists, ASA II) undergoing caesarean section under spinal anaesthesia

Exclusion criteria

Exclusion criteria: 1 Patient refusal 2 3 BMI > 35kg/m2 4 Height 5 Any contraindication to regional anesthesia 6 Twin pregnancy 7 Drug allergy to local anaesthetics/study drugs 8 Refusal to give consent 9 Conversion to general anesthesia

Design outcomes

Primary

MeasureTime frame
To compare the two drugs in terms of Onset of sensory and motor block. 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

MeasureTime frame
To compare the maximum level of sensory block achieved 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 Adverse effects like hypotension, bradycardia, nausea, vomiting, arrythmias, any episode of desaturation(spo2 less than 90%)

Countries

India

Contacts

Public ContactDr SK Singhal

Pt B.D. Sharma PGIMS, Rohtak Haryana

ssinghal12@gmail.com9416391115

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026