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Comparing Two Methods of Giving Spinal Anesthesia (Fractional vs. Single Dose) in Patients Undergoing Lower Abdominal or Leg Surgery: A Study on Safety and Effectiveness

Comparative Study on the Effect of Fractional versus Bolus Dose of Levobupivacaine Used in Spinal Anesthesia in Patients Undergoing Lower Abdominal and Lower Limb Orthopedic Surgery: A Prospective Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090371
Enrollment
120
Registered
2025-07-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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: Fractional Spinal Anaesthesia technique: o The 15 mg dose is divided into two equal portions. o The second half dose is administered after a 45-second interval while maintaining needle

Sponsors

Dr Kashish Garg
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: o ASA physical status I or II. undergoing elective lower abdominal or lower limb orthopedic surgeries.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
1. Fall in mean blood pressure 2. Total number of doses of vasopressor requiredTimepoint: Recorded at baseline and immediately after administering Spinal Anaesthesia, followed by every 2 minutes for the first 10 minutes of administering Spinal Anaesthesia, followed by every 3 min till the next 30 min, followed by every 5 minutes until surgery gets over Assessment will be done every 30 minutes in the postoperative period till sensory and motor variables returns back to normal—

Secondary

MeasureTime frame
1.Onset & duration of sensory & motor blockade. 2.Highest sensory block level achieved. 3.Post-operative pain & time to first rescue analgesia. 4.Incidence of adverse events (e.g., nausea, vomiting, shivering, respiratory distress). Timepoint: Recorded at baseline & immediately after administering Spinal Anaesthesia, followed by every 2 minutes for the first 10 minutes of administering Spinal Anaesthesia, followed by every 3 min till the next 30 min, followed by every 5 minutes until surgery gets over Assessment will be done every 30 minutes in the postoperative period till sensory & motor variables returns back to normal—

Countries

India

Contacts

Public ContactKashish Garg

PGIMER Satellite Centre Sangrur

kashishg83@gmail.com09501188562

Outcome results

None listed

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