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Study to Compare the Effectiveness of Fractionated dose versus Bolus dose of 0.5% Hyperbaric Bupivacaine in patients undergoing Elective Lower Segment Caesarean Section under Spinal Anaesthesia

A Prospective Randomized Double Blinded Study to Compare the Effect of Fractionated dose versus Bolus dose of 0.5% Hyperbaric Bupivacaine in patients undergoing Elective Lower Segment Caesarean Section under Subarachnoid block

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030423
Enrollment
214
Registered
2021-01-13
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: Fractioned Dose of Hyperbaric 0.5% Bupivacaine: Patients will receive 0.5% hyperbaric bupivacaine as fractionated dose. First two third of calculated dose is given initially at 0.2ml/se

Sponsors

Aravindan M
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA status Iââ?¬â??III 2. Age from 18 to 40 years 3. Height from 140 to 180 cm 4. Singleton pregnancies scheduled for elective lower segment caesarean section under subarachnoid block

Exclusion criteria

Exclusion criteria: 1. Patients with pre-existing diseases 2. Pregnancy-induced hypertension 3. Cardiovascular or cerebrovascular disease 4. Any contraindication to SA -spine deformities or history of Laminectomy 5. Patients weighing 100 kg 6. Patients taller than 180 cm or shorter than 140 cm

Design outcomes

Primary

MeasureTime frame
Hemodynamic stability ââ?¬â?? Variations in Heart rate, systolic and diastolic blood pressure, Mean arterial pressure between two groupsTimepoint: After subarachnoid block ââ?¬â?? soon after positioning the patient Every 3mins till delivery of baby Thereafter every 10mins till completion of surgery Postoperative vitals every 30mins in PACU and WARD for the next 6 hours—

Secondary

MeasureTime frame
Intraoperative vasopressor (Ephedrine or Phenylephrine) requirement between the two groupsTimepoint: After subarachnoid block ââ?¬â?? soon after positioning the patient till completion of the surgery and shifting the patient to PACU;return of Bromage score to 0Timepoint: For every 5minutes for the initial 30 minutes after the administration of subarachnoid block At the beginning and at the end of the surgery After the surgery- every 30minutes until the block regress to bromage motor scale 0.;Sensory level Regression time to S2Timepoint: From the administration of subarachnoid block - every 5 minutes until maximum sensory block level is achieved (3 consecutive values with same dermatome level ) At the end of the surgery every 30 mins thereafter until block regresses to S2;Time to first post-operative analgesiaTimepoint: from the time of administration of subarachnoid block till 6 hours post operatively.—

Countries

India

Contacts

Public ContactAravindan M

Sri Ramachandra Institute of Higher Education and Research

thames25@gmail.com9841552333

Outcome results

None listed

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