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A Study To Compare The Sensory And Muscle Paralysis Characteristics Of A Drug Named Levobupivacaine 0.5% Heavy And 0.5% Bupivacaine Heavy For Spinal Anaesthesia for surgery in pregnant patients named caesarean section

A Comparative Study Of Hyperbaric Levobupivacaine 0.5% With Hyperbaric Bupivacaine 0.5% For Spinal Anaesthesia In Elective Lower Segment Cesarean Section Cases - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062467
Enrollment
112
Registered
2024-02-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: - Health Condition 2: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Intervention1: 0.5% Hyperbaric Levobupivacaine: Patient will be positioned in left lateral position and under strict aseptic conditions, lumbar puncture done using midline approach at L2-L3 intervert

Sponsors

Dr Madhu S N
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Parturients posted for Elective Cesarean section and who give written informed consent for spinal anaesthesia. 2.Parturients aged between 18 years and 40 years

Exclusion criteria

Exclusion criteria: 1.Patients refusal to participate in the study. 2.Contraindications to spinal anaesthesia(sepsis, local infections, spinal deformity,coagulopathies). 3.Period of gestation less than 35 weeks and more than 40 weeks. 4.Height less than155cm and more than 175cm. 5.BMI less than 18.5 kg/m2and more than 30 kg/m2. 6.Parturients with gestational hypertension, cardiovascular disorders and other coexisting systemic disorders.

Design outcomes

Primary

MeasureTime frame
To compare the effect of hyperbaric levobupivacaine 0.5% with hyperbaric bupivacaine 0.5% on : Sensory and motor characteristics in subarachnoid block Timepoint: and at every 1minute interval for first 3 consecutive minutes followed by 5 minute intervals for the next 15minutes and at 15 minute intervals till the end of the surgery.

Secondary

MeasureTime frame
To compare the effects of the 2 drugs on heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, saturation of oxygen & the incidence of adverse effects if any Timepoint: and at every 1minute interval for first 3 consecutive minutes followed by 5 minute intervals for the next 15minutes and at 15 minute intervals till the end of the surgery.

Countries

India

Contacts

Public ContactDr Vinay Marulasiddappa

Bangalore Medical College and Research Institute

drvinaym@gmail.com8073997005

Outcome results

None listed

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