| CTRI Number |
CTRI/2025/03/083164 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Method to Abolish or Minimizing Pain in Paediatric Patients Undergoing Surgery |
|
Scientific Title of Study
|
Evaluation of analgesic effect of continous caudal epidural levobupivacaine and ropivacaine in Infraumbilical paediatric surgeries |
| 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 Rohit Raman |
| Designation |
Junior resident |
| Affiliation |
Gandhi Medical College |
| Address |
Block 1 Second Floor Operation theatre Gandhi Medical College and Associated Hamidia Hospital Sultania Road Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
7321812471 |
| Fax |
|
| Email |
ramanrohit1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brajesh Kaushal |
| Designation |
Associate Proffesor |
| Affiliation |
Gandhi Medical College |
| Address |
Block 1 Second Floor Department of Anaesthesiology Gandhi Medical College and Associated Hamidia Hospital Sultania Road Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9425772151 |
| Fax |
|
| Email |
brajeshkaushal3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Brajesh Kaushal |
| Designation |
Associate Proffesor |
| Affiliation |
Gandhi Medical College |
| Address |
Block 1 Second Floor Department of Anaesthesiology Gandhi Medical College and Associated Hamidia Hospital Sultania Road Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9425772151 |
| Fax |
|
| Email |
brajeshkaushal3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gandhi Medical College
Block 1 Second Floor Operation theatre Gandhi Medical College and Associated Hamidia Hospitals Sultania Road Bhopal Madhya Pradesh Pincode 462001 India
|
|
|
Primary Sponsor
|
| Name |
Gandhi Medical College |
| Address |
Block 1 Second Floor Operation theatre Gandhi Medical College and Associated Hamidia Hospitals Sultania Road Bhopal Madhya Pradesh Pincode 462001 India |
| Type of Sponsor |
Government medical college |
|
|
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 Brajesh Kaushal |
Hamidia Hospital |
Department of Anaesthesiology Block 1 Second Floor Operation theatre Gandhi Medical College Sultania Road Bhopal Madhya Pradesh Pincode 462001 India
Bhopal
MADHYA PRADESH |
09425772151
brajeshkaushal3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Receive inj Levobupivacaine 0.25% as bolus followed by inj Levobuoivacaine 0.1% as infusion
|
levobupivacaine 0.25% will be used as a bolus dose
Pharmacological Profile
1. *Levobupivacaine*: A long-acting local anesthetic, S-enantiomer of bupivacaine.
2. *0.25% concentration*: A relatively low concentration, suitable for pediatric patients or for procedures requiring mild to moderate analgesia.
Bolus Dose in Continuous Caudal Epidural
1. *Initial bolus dose*: Typically 0.5-1 mL/kg of 0.25% levobupivacaine.
2. *Continuous infusion*: Followed by a continuous infusion of 0.1-0.2 mL/kg/h of 0.1% levobupivacaine.
Safety Profile
Levobupivacaine has a lower risk of systemic toxicity compared to bupivacaine
|
| Comparator Agent |
Receive Inj. Ropivacaine 0.25% as bolus followed by ini Ropivacaine 0.1% as infusion |
Ropivacaine 0.25% as a bolus dose
Pharmacological Profile
1. *Ropivacaine*: A long-acting local anesthetic, less lipophilic than bupivacaine.
2. *0.25% concentration*: A relatively low concentration, suitable for pediatric patients or for procedures requiring mild to moderate analgesia.
Bolus Dose in Continuous Caudal Epidural
1. *Initial bolus dose*: Typically 0.5-1 mL/kg of 0.25% ropivacaine.
2. *Continuous infusion*: Followed by a continuous infusion of 0.1-0.2 mL/kg/h of 0.25% ropivacaine.
Safety Profile
Ropivacaine has a lower risk of systemic toxicity compared to bupivacaine.
Pediatric Considerations
1. *Dosing*: Pediatric dosing typically starts at 0.5 mL/kg of 0.25% ropivacaine.
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|
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Inclusion Criteria
|
| Age From |
30.00 Day(s) |
| Age To |
4.00 Year(s) |
| Gender |
Both |
| Details |
Either sex of age 30 days to 4 years undergoing infraumbilical surgeries.
ASA Grades I and II. |
|
| ExclusionCriteria |
| Details |
Patients/Parent refusal
Coagulation abnormalities/bleeding diathesis
ASA Grades III and IV
Patients having a history of significant neurological,psychiatric,neuromuscular disorders
Any cardiac disease
History of allergic reactions to local anaestheic agents |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the analgesic effect and to compare the duration of postoperative pain relief achieved in continuous caudal epidural in infraumbilical pediatric surgeries |
Assessment of post operative pain after completion of surgery at 2,4,6 hr after surgery and thereafter 6 hourly till 24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To asess the requirement of any add on analgesia in post operative period |
Assessment of post operative pain after completion of surgery at 2,4,6 hr after surgery and thereafter 6 hourly till 24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
24/05/2025 |
| 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="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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-identiļ¬cation.
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ramanrohit1995@gmail.com].
- For how long will this data be available start date provided 17-02-2025 and end date provided 18-02-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
Caudal Epidural Anaesthesia will be administered under sedation with Ketamine or Midazolam in standard dose as per requirement of surgery. The patient will be positioned in the left lateral and under full aseptic precautions; a sterile 22 gauge needle will be introduced in the caudal epidural space. After confirming the position of the needle with Loss of resistance technique the allocated drug will be given slowly over 60sec. Epidural Catheter will be inserted and secured in caudal space. Intraoperatively bolus dose of levobupivacaine or ropivacaine will be administered. After 15 minutes infusion will be started. Then, the patient will be turned to supine position; anesthesia will be maintained with Midazolam/Ketamine and oxygen will be connected.
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