Comparison of efficacy between two Local anesthetic drugs[0.25 % BUPIVACAINE and 0.25% LEVOBUPIVACAINE] for caudal anesthesia in pediatric patients for below umbilical surgeries

COMPARISON OF EFFICACY BETWEEN 0.25% BUPIVACAINE AND 0.25% LEVOBUPIVACAINE FOR CAUDAL ANESTHESIA IN PEDIATRIC INFRAUMBILICAL SURGERIES

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/048753

Enrollment

Registered

2023-01-04

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

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

Conditions

Health Condition 1: Z768- Persons encountering health services in other specified circumstances

Interventions

Intervention1: LEVOBUPIVACAINE: 0.75ml/kg of 0.25% levobupivacaine will be administered.Duration ofanalgesia,duration of motor blockade,hemodynamic parameters and incidence of adverse effects will be

Eligibility

Inclusion criteria

Inclusion criteria: Patients posted for elective infraumbilical surgeries. Age between 2 years to 8 years of either sex. Weight between 9 to 35kg. Anticipated duration of surgery ASA grade Ð? or â?¡.

Exclusion criteria

Exclusion criteria: Emergency surgeries. Known hypersensitivity to amide local anaesthetics. History of active neurological, cardiac, respiratory and renal diseases. Blood dyscrasia, clotting disorders and platelet count Patients with cutaneous infections or anatomical malformation of the spine. Patients not willing to participate in the study

Design outcomes

Primary

Measure	Time frame
Duration of analgesiaTimepoint: pain score by FLACC score for every 15minutes in the first hour and every 30minutes for next hour	—

Secondary

Measure	Time frame
To compare the duration of motor blockade between 0.25%bupivacaine and 0.25%levobupivacaineTimepoint: duration of motor blockade by MODIFIED BROMAGE SCALE for every 15minutes in the first hour and every 30minutes for next hour;To compare the hemodynamic parameters between 0.25%bupivacaine and 0.25% levobupivacaineTimepoint: Pulse rate,Blood pressure and oxygen saturation from baseline to every 3minutes for 15minutes and every 5minutes for 30minutes and every 30 minutes fot 120 minutes;To compare the incidence of adverse effects between 0.25%bupivacaine and 0.25% levobupivacaineTimepoint: Number of adverse effects in the perioperative period	—

Measure

Time frame

To compare the duration of motor blockade between 0.25%bupivacaine and 0.25%levobupivacaineTimepoint: duration of motor blockade by MODIFIED BROMAGE SCALE for every 15minutes in the first hour and every 30minutes for next hour;To compare the hemodynamic parameters between 0.25%bupivacaine and 0.25% levobupivacaineTimepoint: Pulse rate,Blood pressure and oxygen saturation from baseline to every 3minutes for 15minutes and every 5minutes for 30minutes and every 30 minutes fot 120 minutes;To compare the incidence of adverse effects between 0.25%bupivacaine and 0.25% levobupivacaineTimepoint: Number of adverse effects in the perioperative period

—

Countries

India

Contacts

Public ContactJaisima Balaji S

Sri manakula vinayagar medical college and hospital

lazarus.suneeth@gmail.com9894332543

Outcome results

None listed

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