Skip to main content
Clinical Trials/CTRI/2025/07/091837
CTRI/2025/07/091837Not yet recruitingNot Applicable

A prospective observational clinical trial to assess the efficacy of perfusion index (PI) as a predictor of onset of pediatric caudal block under general anesthesia

SINGAREDDY SUMANTH KUMAR REDDY1 site in 1 country77 target enrollmentStarted: August 10, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
77
Locations
1
Primary Endpoint
To compare the role of PI, HR, and Mean Arterial Pressure (MAP) in detecting the onset and adequacy of caudal block.

Study Overview

Brief Summary

Caudal block under general anesthesia is quite popular for pediatric lower limb surgeries as it is one technique that fits all. It is relatively easy to learn with a high mean success rate and a remarkable safety record. However, failure of the caudal block is about 4% due to abnormal anatomy, operator inexperience and wrong choice of block.

It is often very difficult to assess the quality of analgesia in children intra-operatively as most of the regional blocks are performed under general anesthesia or sedation in contrast to adults. Conventionally one waits to see the patient’s response to the surgical skin incision to make a clinical decision of working caudal block. Unsuccessful block causes a raise in HR, Blood Pressure on skin due to pain. This calls for more reliable and faster objective parameters that can confirm the efficacy of caudal block in children.

Recent advances in Pulse Oximeter technology have broadened the ability to measure more parameters such as Perfusion Index (PI). PI is a noninvasive numerical assessment of the pulsatile strength at a monitoring site providing useful information about the peripheral perfusion status of the patient. A decrease in PI can occur because of local vasoconstriction while vasodilatation results in an increase in PI in the skin at the monitoring site. Recent studies recommended that PI can be used as an early and sensitive indicator to detect the development of epidural-induced sympathectomy leading to vasodilation and increased perfusion in adults. In adult population many numbers of studies done and most of them concluded that PI is the best tool in predicting the onset and adequacy of caudal block. In children especially in Indian population, the studies that have been done are very limited. This study that mainly focusing on pediatric population might be helpful to assess whether PI can be applied to detect the onset and adequacy of caudal block under GA similar to adults. Hence in this study we tried to compare the role of PI, HR and Mean Arterial Pressure (MAP) in detecting the onset and adequacy of caudal block.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
1.00 Year(s) to 6.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA grade 1 and 2, undergoing infraumbilical surgeries.

Exclusion Criteria

  • who are allergic to local anaesthetics, with coagulation abnormalities, spinal abnormalities, neurological deficits and infection at the site of caudal block.

Outcomes

Primary Outcomes

To compare the role of PI, HR, and Mean Arterial Pressure (MAP) in detecting the onset and adequacy of caudal block.

Time Frame: first 20 minutes during surgery

Secondary Outcomes

  • To monitor PI trends after caudal epidural anesthesia in children(first 20 minutes during surgery)

Investigators

Sponsor
SINGAREDDY SUMANTH KUMAR REDDY
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

SINGAREDDY SUMANTH KUMAR REDDY

Jawaharlal Nehru Medical College

Study Sites (1)

Loading locations...

Similar Trials