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Clinical Trials/CTRI/2024/07/071598
CTRI/2024/07/071598
Not yet recruiting
Phase 4

Comparison of ultrasound versus landmark-guided caudal block in neonates and infants: A randomized controlled study

Medical college baroda department of anaesthesia india gujrat1 site in 1 country80 target enrollmentStarted: August 5, 2024Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Medical college baroda department of anaesthesia india gujrat
Enrollment
80
Locations
1
Primary Endpoint
1.1st Attempt success rate

Overview

Brief Summary

The aim of our study is compare the first attempt success rate and efficacy of ultrasound versus landmark guided caudal block.80 patients belonging to age group <= 1 year with ASA II or III are randomly selected into two groups.In group US ultrasound guided caudal block given to neonates and infants and in group LB landmark guided caudal block given to neaonates and infants. The primary objective is to compare the first attempt success rate in both group.Block performance time, number of needle puncture,tachycardia on putting incision, duration if post operative analgesia,complication of block are the secondary parameters and also noted in both the groups. The proposed advantage of our study is first attempt success rate is higher in ultrasound guided caudal block.

Study Design

Study Type
Interventional
Allocation
Randomized

Eligibility Criteria

Ages
1.00 Day(s) to 1.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients undergoing posted for elective or emergency lower abdominal surgery like non-obstructed inguinal hernia, anoplasty, colostomy, circumcision etc.
  • Term neonates and age £ 1 year
  • Patients conformed to American Society of Anaesthesiologists (ASA) physical status -II-III in preoperative assessment
  • Ability to follow the study protocol by parents.

Exclusion Criteria

  • Neonates with upper/midgut obstruction 2) Coagulation abnormalities 3) Sacral anomalies 4) Long-duration surgeries with major fluid shifts 5) Neuromuscular or metabolic disorders 6) Systemic infection 7) Meningitis 8) Local infection at the site of puncture 9) Raised intra-cranial tension.

Outcomes

Primary Outcomes

1.1st Attempt success rate

Time Frame: At basline

Secondary Outcomes

  • 1. Time to perform the block(2. Number of needle punctures required for successful block)

Investigators

Sponsor
Medical college baroda department of anaesthesia india gujrat
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Jayanam patel

Government medical college,baroda

Study Sites (1)

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