MedPath

A study to compare effects of different combinations of drugs when given in caudal block for surgery involving below umblicus.

Recruiting
Conditions
any child undergoing lower abdominal surgery for any disease
Registration Number
CTRI/2018/09/015673
Lead Sponsor
Jyoti
Brief Summary

The study will be comparing the effect of drug combinations given in caudal block analgesia for the post  operative pain relief in the patients. The patients will be children in the age group of 2 to 10 years who will be randomly allocated into 3 groups which will be receiving a particular combination of the drugs.  Group I - Levo Bupivacaine 0.25% 1 ml/kg , Group II - Levo Bupivacaine 0.25% 1ml/kg + tramadol 1mg/kg and Group III - Levo bupivacaine 1 ml/kg + Clonidine 1ug/kg after administration of general anaesthesia but before the start of surgery. Outcome will be measured as haemodynamic stability measured in terms of HR, MAP every 5, 10, 15, 30, 45, 60 and 90 mins intra operatively till the completion of the surgery and then duration of post operative analgesia in these patients measured with the help of CHIPPS score and Ramsay sedation score and also hemodynamic parameters at 1 hour interval till the 6th hour and then at 24 hours.

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
All
Target Recruitment
75
Inclusion Criteria

children in ASA status 1 and 2 undergoing any type of surgical procedure in the lower abdominal region.

Exclusion Criteria

ASA status 3,4 or 5 Any contraindication to caudal block such as scaral agenesis, tumors, local infection history of seizures hypersensitivity to any of the drugs in the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
time duration of analgesia in the post operative periodtime duration of analgesia in the post operative period measured at 5, 10, 15,30,45,60,90 minutes
Secondary Outcome Measures
NameTimeMethod
hemodynamic stability in the intra operative period5,10,15,30,45,60,90 intra operatively

Trial Locations

Locations (1)

King geroge medical university

🇮🇳

Lucknow, UTTAR PRADESH, India

King geroge medical university
🇮🇳Lucknow, UTTAR PRADESH, India
Jyoti Rawat
Principal investigator
9616377999
jyotipoojakuhu@gmail.com

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.