A study of comparison between the conventional anatomy based caudal analgesia and ultrasound guided caudal analgesia in paediatric patients undergoing surgeries below the level of umbilicus

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/02/040291
• Lead Sponsor: Department of Anaesthesiology IPGMER and SSKM Hospital

Brief Summary

This study will help us compare the effectiveness and safety profile for caudal epidural blocks given by anatomical landmark based conventional method and the same given by USG guidance. With the help of real-time ultrasound imaging the procedure is expected to be given more safely avoiding inadvertent injection of local anaesthetics into intravascular and subarachnoid spaces

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-17
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• a) Patients belonging to either sex of age 1 month to less than 12 years.
• b) Patients of ASA physical status I and II.
• c) Patients scheduled to undergo various elective infra-umbilical surgeries.

Exclusion Criteria

• a) Patients aged less than 1 month b) Refusal from parents to give consent for the procedure.
• c) Patients with evidence of peripheral neuropathy, neurological deficit or motor weakness.
• d) Patients with significant cardiac, respiratory, hepatic or renal disorders or any other uncontrolled systemic illness e) Bleeding diatheses or history of using anticoagulation medications f) History of pneumothorax g) History of allergy to amide local anaesthetics.
• h) Infection at the site of needle insertion.
• i) History of seizures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) proper needle placement	Outcome will be monitored during performing the procedure. This is not a therapeutic study hence duration of the procedure (from placing the ultrasound probe to placement of the needle in the caudal epidural space) will be considered as time points.
2) no aspiration of blood	Outcome will be monitored during performing the procedure. This is not a therapeutic study hence duration of the procedure (from placing the ultrasound probe to placement of the needle in the caudal epidural space) will be considered as time points.
3) no aspiration of cerebrospinal fluid	Outcome will be monitored during performing the procedure. This is not a therapeutic study hence duration of the procedure (from placing the ultrasound probe to placement of the needle in the caudal epidural space) will be considered as time points.
4) no swelling in the sacral region	Outcome will be monitored during performing the procedure. This is not a therapeutic study hence duration of the procedure (from placing the ultrasound probe to placement of the needle in the caudal epidural space) will be considered as time points.

Secondary Outcome Measures

Name	Time	Method
An effective caudal analgesia without major hemodynamic alterations and avoiding inadvertent intravascular injection or dural puncture	Intraoperative and 30 minutes after the surgery

Trial Locations

Locations (1)

IPGMER and SSKM Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

IPGMER and SSKM Hospital

🇮🇳Kolkata, WEST BENGAL, India

Dr Maitreyee Mukherjee

Principal investigator

9830415924

maitreyee1980.mm@gmail.com