Pain Management in children undergoing Hernia repair

Active, not recruiting

Conditions: paediatric patients posted for herniotomy

Registration Number: CTRI/2014/06/004679

Lead Sponsor: Department of Anaesthesiology

Brief Summary: Caudal block is widely used in children, it significantly decreases the requirements of systemic anaesthetic and analgesic agents. This results in better post operative outcome. Bupivacaine has been widely used and extensively studied over decades. The cardiac toxicity of Bupivacaine stimulated interest in developing less toxic , long lasting local anaesthetic.

Levobupivacaine, a pure S enantiomer of bupivacaine, was approved by the US FDA in 1999. It has a wider margin of safety with same analgesic efficacy and less post operative motor blockade. It has been studied extensively in the western world.

Levobupivacaine has been recently introduced in the Indian market. It has been used in paediatric population without any untoward event and with acceptable level of motor blockade. To the best of our nowledge there have been no studies in the Indian paediatric population.

Hence we decided to do an observational study comparing same concentrations of Levobupivacaine and Bupivacaine for caudal analgesia.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 60

Inclusion Criteria

American society of anaesthesiologists Class 1 and Class 2 Paediatric patients scheduled for elective herniotomy.

Exclusion Criteria

history of previous surgeries requiring handling of spinal cord neurological disorder cardiac disorder local infection pre existing bleeding disorder hypersensitivity to any drugs sacral abnormalities.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
clinical efficacy of caudal blockade during surgery	caudal block efficacy is absence of gross motor movents or more than 20% change in heart rate and respiratory rate on application of forcep after 15 minutes following caudal block. \| residual motor blockade defined as motor block score of more than 1 at wake up and 180 minutes after caudal block
residual motor blockade	caudal block efficacy is absence of gross motor movents or more than 20% change in heart rate and respiratory rate on application of forcep after 15 minutes following caudal block. \| residual motor blockade defined as motor block score of more than 1 at wake up and 180 minutes after caudal block

Secondary Outcome Measures

Name	Time	Method
pain scores	15 minutes for first hour postoperatively and then half hourly for next two hours
requirement of rescue analgesia	rescue analgesia when pain score of more than 4
duration of analgesia	15 minutes for first hour postoperatively and then half hourly for next two hours

Trial Locations

Locations (1): Lokmanya Tilak Municipal Medical College and General Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Lokmanya Tilak Municipal Medical College and General Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Poonam Jadhav
Principal investigator
919819136902
poons910@gmail.com