FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/078491 [Registered on: 24/12/2024] Trial Registered Prospectively
Last Modified On: 13/12/2024
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   Comparison of two methods of pain relieving methods in paediatric patients undergoing surgeries in the inguinal region.  
Scientific Title of Study   Comparison of Analgesic Efficacy of Ultrasound Guided Retrolaminar Block vs Caudal Block for Paediatric Patients Undergoing Open Inguinal Surgeries: A Non-Inferiority Randomised 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 Suman Das 
Designation  Academic Junior Resident  
Affiliation  AIIMS Patna 
Address  Department of Anaesthesiology OT Complex,5th floor AIIMS Patna Phulwarisharif Patna Bihar 801507 India

Patna
BIHAR
801507
India 
Phone    
Fax    
Email  drsumandasapu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhyuday Kumar 
Designation  Associate Professor  
Affiliation  AIIMS Patna 
Address  Department Of Anaesthesiology OT Complex,5th Floor AIIMS Patna Phulwarisharif,Patna,Bihar,India

Patna
BIHAR
801507
India 
Phone  9013512403  
Fax    
Email  drabhyu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhyuday Kumar  
Designation  Associate Professor  
Affiliation  AIIMS Patna 
Address  Department of Anaesthesiology OT Complex,5th Floor AIIMS Patna Phulwarisharif,Patna,Bihar,India

Patna
BIHAR
801507
India 
Phone  9013512403  
Fax    
Email  drabhyu@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, All India Institute of Medical Sciences,Patna,Phulwarisharif,Bihar,India,Pin :801507 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Patna 
Address  Department of Anaesthesiology,OT Complex 5th floor, AIIMS Patna,Phulwarisharif,Patna,Bihar, Pin :801507, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suman Das  All India Institute of Medical Sciences,Patna  Department of Anaesthesiology,OT Complex,6th floor,Patna,Bihar
Patna
BIHAR 		 6297672646

drsumandasapu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Caudal Block  Block will be given after general anesthesia in lateral position under ultrasound guidance by an experienced anaesthesiologist. A volume of 1 ml per kg body weight of 0.25% levobupivacaine will be given in the block.  
Intervention  Retrolaminar Block  Block will be given after general anesthesia in lateral position under ultrasound guidance by an experienced anaesthesiologist. A volume of 0.5 ml per kg body weight of 0.25% levobupivacaine will be given in the block.  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Age 1-6years
ASA I and II patients scheduled for inguinal surgeries. 
 
ExclusionCriteria 
Details  Patients with coagulation disorders
Patients hypertensive to study medications
Patients with developmental or mental delay
Skin lesions or infection at the planned site of needle insertion
Congenital vertebral anomalies
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to first rescue analgesia  assessment within 24 hours post surgery estimated at 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours.  
 
Secondary Outcome  
Outcome  TimePoints 
Intraoperative fentanyl use
Number of patients requiring rescue analgesia in 24hours/till the time of discharge
Total dose of rescue analgesia in 24hours
FLACC score at 30minutes,2,4,6,8,12 and 24 hours
Complications like hypotension,bradycardia,motor blockage and urinary retension. 		 30minutes,2hour,4hour,6hour,8hour,12hour,24hours/till the time of discharge 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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 4 
Date of First Enrollment (India)   24/12/2024 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will provided by the primary investigator on request through email after approval from the institute.

  6. For how long will this data be available start date provided 01-06-2026 and end date provided 01-06-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Regional anaesthesia for inguinal surgeries in children has attracted increasing interest and different technique like like subarachnoid,caudal,epidural block,wound infiltration,ilioinguinal and paravertebral block have been used with varying success.
In Paediatric surgery caudal block is a low cost,simple and effective procedure for post operative analgesia.
Retrolaminar Block is one of the newer and simpler alternative technique to the traditional caudal block.Drug is deposited into the retrolaminar spacebetween the lamina of T12 and paraspinal muscle.
Caudal block is most common regional anaesthesia technique used for inguinal surgeries in paediatric patients. Caudal block is not free of complications and can include side effects and complications like hypotension,motor blockage,urinary retension,subdural,intravascular or intraosseus injections of the drug,injury to nerve roots and spinal cord infections etc.Retrolaminar block in other hand is less invasive and the target is away from neuroaxis,rendering it potentially safe.
Through this study,we are trying to explorean alternative regional anaesthesia technique that is less invasive with non-inferior analgesic benefit compared to Caudal block.
No RCT has been conducted till date comparing Retrolaminar Block to Caudal block in paediatric patients.
We expect that Retrolaminar Block will provide analgesia non inferior to Caudal block in Paediatric patients undergoing inguinal surgeries.This will help us to inculcate this block as routine practice in our setup in this subset of patients.
 
Close