| CTRI Number |
CTRI/2025/07/091837 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
“Studying Finger Pulse Changes to Detect the Effect of Nerve Block in Children Undergoing Surgery Under Anesthesia” |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SINGAREDDY SUMANTH KUMAR REDDY |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
J.N MEDICAL COLLEGE, BELAGAVI,
KARNATAKA -590010
DEPARTMENT OF ANAESTHESIOLOGY
J.N MEDICAL COLLEGE, BELAGAVI,
KARNATAKA -590010 Belgaum KARNATAKA 590010 India |
| Phone |
8448365364 |
| Fax |
|
| Email |
DOCSUMANTHREDDY@GMAIL.COM |
|
Details of Contact Person Scientific Query
|
| Name |
MANJUNATH C PATIL |
| Designation |
PROFESSOR |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
J.N MEDICAL COLLEGE, BELAGAVI,
KARNATAKA -590010
DEPARTMENT OF ANAESTHESIOLOGY
J.N MEDICAL COLLEGE, BELAGAVI,
KARNATAKA -590010 Belgaum KARNATAKA 590010 India |
| Phone |
9743322063 |
| Fax |
|
| Email |
MCPATIL52@GMAIL.COM |
|
Details of Contact Person Public Query
|
| Name |
SINGAREDDY SUMANTH KUMAR REDDY |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
J.N MEDICAL COLLEGE, BELAGAVI,
KARNATAKA -590010
DEPARTMENT OF ANAESTHESIOLOGY
J.N MEDICAL COLLEGE, BELAGAVI,
KARNATAKA -590010 Belgaum KARNATAKA 590010 India |
| Phone |
8448365364 |
| Fax |
|
| Email |
DOCSUMANTHREDDY@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi 590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
SINGAREDDY SUMANTH KUMAR REDDY |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
J.N MEDICAL COLLEGE, BELAGAVI,
KARNATAKA -590010 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SINGAREDDY SUMANTH KUMAR REDDY |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre |
2nd floor, Department of Anaesthesiology, JNMC,Belgaum Belgaum KARNATAKA |
08448365364
DOCSUMANTHREDDY@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Medical and Surgical |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2, undergoing infraumbilical surgeries |
|
| ExclusionCriteria |
| Details |
who are allergic to local anaesthetics, with coagulation abnormalities, spinal abnormalities, neurological deficits and infection at the site of caudal block |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the role of PI, HR, and Mean Arterial Pressure (MAP) in detecting the onset and adequacy of caudal block. |
first 20 minutes during surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor PI trends after caudal epidural anesthesia in children |
first 20 minutes during surgery |
|
|
Target Sample Size
|
Total Sample Size="77" Sample Size from India="77"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [DOCSUMANTHREDDY@GMAIL.COM].
- For how long will this data be available start date provided 13-07-2025 and end date provided 13-10-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
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. |