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A study to compare the fractionated and single bolus dose of hyperbaric bupivacaine during spinal anesthesia in lower limb orthopedic surgeries - A randomised controlled trial.

A comparative study of fractionated versus single bolus dose of hyperbaric bupivacaine during spinal anesthesia in lower limb orthopedic surgeries - A randomised controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110129
Enrollment
100
Registered
2026-05-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Fractionated dose of spinal anesthesia: Giving fractionated dose of 3ml divided into two aliquots of 2ml and 1ml in spinal anesthesia in patients undergoing lower limb orthopedic surger

Sponsors

NESHITA NASKAR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients that have given written, informed consent to participate in the study. 2. ASA physical status 1 and 2. 3. Patients aged between 18-65 years of age of either sex. 4. Patients undergoing orthopedic surgery under spinal anesthesia.

Exclusion criteria

Exclusion criteria: 1. Refusal to consent. 2. Repeated attempts and failure to block. 3. Allergy to local anesthestics or drugs involved in the study. 4. Pregnancy and lactation. 5. Contraindication to regional nerve block(bleeding disorder, infection at site). 6. Pre- existing neurological deficits.

Design outcomes

Primary

MeasureTime frame
To compare the incidence of hypotension after spinal anesthesia between fractionated and single bolus dose of spinal anesthesia.Timepoint: Blood pressure will be monitored continually at 5 minutes interval for first 30 minutes and then at 10minutes interval for the rest of the surgery.

Secondary

MeasureTime frame
To compare incidence of bradycardia, assess requirement of vasopressor drugs, & to compare the block characteristics (onset & duration of sensory & motor block)Timepoint: Heart rate & SpO2 will be continuously monitored at 5 minutes interval for 30minutes & then at 10minutes interval for the rest of the surgery.

Countries

India

Contacts

Public ContactDr Parvin Banu

Institute of Postgraduate Education and Research and SSKM hospital

Parvin_dear@yahoo.com9433133027

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026