A study to compare ropivacaine with fentanyl and bupivacaine fentanyl for caudal epidural in paediatric surgeries

Not yet recruiting

• Conditions: Diseases of the genitourinary system,

• Registration Number: CTRI/2020/02/023184
• Lead Sponsor: Divya S

Brief Summary

This is a randomized controlled trial to compare the efficacy of Ropivacaine with Fentanyl and Bupivacaine with Fentanyl and to assess post operative early ambulation in single shot caudal epidural in paediatric infra umbilical surgeries among 60 patients over a period of 18 months. The primary objective is to To compare the time taken for regression of motor blockade in terms of post operative early ambulation. The secondary outcomes  to assess intra operative and post operative hemodynamic stability upto 24 hours, duration of sensory analgesia and the time to the first demand for rescue analgesia and Post Operative Nausea, Vomiting and Sedation Score

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-06-02
• Study Start: 2020-10-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients undergoing infra umbilical surgeries of either sex American Society of Anaesthesiologist I or II.

Exclusion Criteria

Patients allergic to local anesthetics/Fentanyl American Society of Anaesthesiologist III and above Patients with coagulation disorders Local site infection Congenital sacral anomalies Severe CVS abnormalities Renal or Hepatic Failure Neuromuscular disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the time taken for regression of motor blockade in terms of post operative early ambulation	Post Operative Period

Secondary Outcome Measures

Name	Time	Method
To assess intra operative and post operative hemodynamic stability upto 24 hours	Duration of sensory analgesia and the time to the first demand for rescue analgesia

Trial Locations

Locations (1)

Shri Sathya Sai Medical College and Research Institute; 🇮🇳 Kancheepuram, TAMIL NADU, India

Shri Sathya Sai Medical College and Research Institute

🇮🇳Kancheepuram, TAMIL NADU, India

Divya S

Principal investigator

9003268274

divyaroja1994@gmail.com