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

Phase 3

Not yet recruiting

• Conditions: Persons encountering health services in other specified circumstances,

• Registration Number: CTRI/2023/01/048753
• Lead Sponsor: Jaisima Balaji S

Brief Summary

In Anaesthesia, provision of pain relief is an essential part. One of the most popular regional blocks in children with higher success rate is caudal block for surgeries below the level of umbilicus. It is a useful adjunct technique during general  anesthesia and for providing post of analgesia for infra umbilical operations. This technique is  easier to perform and reduces the requirement of inhaled and intravenous anesthetic agent. It also attenuates the stress response to surgery, facilitates rapid and smooth recovery and provides reliable analgesia in the immediate post operative period. The quality and level of caudal block is dependent on the dose, volume and concentration of the drug injected. Bupivacaine is long-acting amide local anesthetic that has provided reliable anesthesia and analgesia with differential motor sensory blockade for more than 40years. Cardio toxicity and incidents of prolonged motor blockade urged the need for the development of a drug with wider margin of safety and similar clinical efficacy. So, S-enantiomers of bupivacaine were isolated and synthesized. One of the pure S-enantiomer of bupivacaine is levobupivacaine. It is claimed to have a wider margin of safety like less cardio toxicity and less post operative motor blockade.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-12-15
• Study Start: 2023-10-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

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 <60 minutes.
• ASA grade І or â…¡.

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 <100000 mm3.
• Patients with cutaneous infections or anatomical malformation of the spine.
• Patients not willing to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of analgesia	pain score by FLACC score for every 15minutes in the first hour and every 30minutes for next hour

Secondary Outcome Measures

Name	Time	Method
To compare the duration of motor blockade between 0.25%bupivacaine and 0.25%levobupivacaine	duration of motor blockade by MODIFIED BROMAGE SCALE for every 15minutes in the first hour and every 30minutes for next hour
To compare the incidence of adverse effects between 0.25%bupivacaine and 0.25% levobupivacaine	Number of adverse effects in the perioperative period
To compare the hemodynamic parameters between 0.25%bupivacaine and 0.25% levobupivacaine	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

Trial Locations

Locations (1)

Sri manakula vinayagar medical college and hospital; 🇮🇳 Pondicherry, PONDICHERRY, India

Sri manakula vinayagar medical college and hospital

🇮🇳Pondicherry, PONDICHERRY, India

JAISIMA BALAJI S

Principal investigator

7708787091

jaibalaji39@gmail.com