| CTRI Number |
CTRI/2025/10/095765 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study testing if adding a small dose of steroid medicine makes anaesthesia for children’s lower-body surgeries work better and last longer |
|
Scientific Title of Study
|
Efficacy of caudal block with or without Dexamethasone as an adjuvant by using perfusion index as an indicator in paediatric patients undergoing infra-umbilical surgeries- A Randomized double-blind, controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shreja Saha |
| Designation |
Post Graduate Trainee - 1(M.D Anaesthesiology) |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology, Kalinga Institute of Medical Sciences, Third Floor, Bhuwaneswar,Orissa
Khordha
Khordha
ORISSA
751024
India |
| Phone |
8017128573 |
| Fax |
|
| Email |
shrejasaha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh Kumar Dash |
| Designation |
Professor(Anaesthesiology) |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology, Kalinga Institute of Medical Sciences, Third Floor, Bhuwaneswar,Orissa
Khordha
ORISSA
751024
India |
| Phone |
8779478574 |
| Fax |
|
| Email |
gasdoc2001@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sapna Das |
| Designation |
Assistant Professor |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology, Kalinga Institute of Medical Sciences, Third Floor, Bhuwaneswar,Orissa
Khordha
ORISSA
751024
India |
| Phone |
9078826164 |
| Fax |
|
| Email |
dr.sapnadas88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical Sciences,
Third Floor,
Bhuwaneswar,
Orissa
Khordha
751024
India |
|
|
Primary Sponsor
|
| Name |
Dr Shreja Saha |
| Address |
Department of Anaesthesiology, Kalinga Institute of Medical Sciences, Third Floor, Bhuwaneswar,Orissa
PIN-751024 |
| 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 Shreja Saha |
Pradyumna Bal Memorial Hospital, Kalinga Institute of Medical Sciences |
Department of Anaesthesiology, Kalinga Institute of Medical Sciences,Bhuwaneswar,Orissa
Khordha, 751024
Khordha
ORISSA |
8017128573
shrejasaha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE KALINGA INSTITUE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1 ml/kg of 0.125% Bupivacaine with 0.1 mg/kg Dexamethasone |
Group D: Patients will receive caudal block with local anaesthetic 0.125% bupivacaine 1ml/kg and dexamethasone (0.1 mg/kg to be prepared with volume of 2 ml) as adjuvant once the patient induced |
| Comparator Agent |
1 ml/kg of 0.125% Bupivacaine with saline |
Group S: Patients will receive caudal block with local anaesthetic 0.125% bupivacaine 1ml/kg with 2ml of normal saline once the patient is induced. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anaesthesiologists (ASA) physical status I, II and III
2. Age- 2 -10 yrs patients
3. Posted for elective infra umbilical surgeries (e.g., inguinal hernia repair, orchidopexy, circumcision, lower limb procedures) requiring caudal block.
|
|
| ExclusionCriteria |
| Details |
1. Suspected coagulopathy
2.Patients with severe peripheral vascular disease, Raynauds disease, or poor peripheral circulation.
3. Known allergy to drugs used in the study
4. Patients with infection at the site of caudal block, sacral bone abnormalities.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in perfusion index (PI) after caudal block |
baseline value, intraoperatively in intervals of 15 minutes and postoperatively at intervals of 3 hours, 6 hours, 9 hours and 12-hour.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess change in intraoperative heart rate, Blood pressure and Spo2 after caudal block |
Intraoperatively every 15 mins and postoperative hemodynamic changes and postoperatively at intervals of 3 hours, 6 hours, 9 hours and 12-hours. |
| Post operative pain is observed using Face Pain Scale |
At intervals of 3 hours, 6 hours, 9 hours and up to 12 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
19/10/2025 |
| 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="2"
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 - NO
|
|
Brief Summary
|
Caudal block is used for pain relief in paediatric infraumbilical surgeries. Adding dexamethasone prolongs analgesia and improves perfusion. Perfusion Index, measured by pulse oximetry, serves as an early marker of block effectiveness. Children will undergo preanesthetic evaluation, consent, and premedication with IV midazolam. Standard monitoring will be applied, and anaesthesia induced with sevoflurane or propofol, along with fentanyl and muscle relaxant. After airway management, anaesthesia will be maintained with oxygen, Nitrous oxide, and sevoflurane. A caudal block will be performed: Group S will receive 0.125% Bupivacaine with saline, while Group D will receive 0.125% bupivacaine with 0.1mg/kg dexamethasone. Intraoperative monitoring of PI,HR, BP, oxygen saturation will be recorded every 15 minutes. Postoperatively, PI and hemodynamic parameters will be assessed at 3, 6, 9, and 12 hours, along with pain scores using the Faces Pain Scale. |