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CTRI Number  CTRI/2024/08/072809 [Registered on: 21/08/2024] Trial Registered Prospectively
Last Modified On: 01/09/2025
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   Analgesic Efficacy of Ultrasound Guided Sacral Erector Spinae Block for Paediatric Patients Undergoing Lower Limb Orthopaedic Surgery 
Scientific Title of Study   Comparison of Analgesic Efficacy of Ultrasound Guided Sacral Erector Spinae Block vs Caudal Block for Paediatric Patients Undergoing Lower Limb Orthopaedic Surgery: A 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  Vikram Chandra 
Designation  Senior Resident 
Affiliation  AIIMS, patna 
Address  All India institue of medical sciences, patna, Bihar

Patna
BIHAR
801507
India 
Phone  9661681476  
Fax    
Email  vikram93chandra@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Chandni sinha 
Designation  professor 
Affiliation  AIIMS, patna 
Address  All India institue of medical sciences, patna, Bihar

Patna
BIHAR
801507
India 
Phone  7250333148  
Fax    
Email  chandni.doc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vikram Chandra 
Designation  Senior Resident 
Affiliation  AIIMS, patna 
Address  All India institue of medical sciences, patna, Bihar

Patna
BIHAR
801507
India 
Phone  9661681476  
Fax    
Email  vikram93chandra@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of medical sciences,Phulwarisharif, Patna, Bihar-801507 
 
Primary Sponsor  
Name  AIIMS Patna 
Address  All India institute of medical sciences, Phulwarisharif, Patna, Bihar-801507 
Type of Sponsor  Research institution and hospital 
 
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 Vikram Chandra  All India institute of medical sciences, patna  6th floor OT complex , Department of Anaesthesiology
Patna
BIHAR 
9661681476

vikram93chandra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee, All India institute of medical sciences, Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Caudal block  Caudal block with 1ml per kg body weight with 0.2 percent ropivacaine. Will assess pain score till 24-hour postoperative period 
Intervention  SACRAL ERECTOR SPINAE BLOCK  Ultrasound-guided Sacral ESP block with 1ml per kg body weight with 0.2 percent ropivacaine. Will assess pain score till 24-hour postoperative period 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1. Age 1-8 years
2. ASA I and II patients scheduled for unilateral lower limb orthopaedic surgery 
 
ExclusionCriteria 
Details  1. Parent refusal to participate in the study.
2. Patients with coagulation disorders.
3. Patients hypersensitive to study medications.
4. Patients with developmental or mental delay.
5. Skin lesions or infection at the planned site of needle insertion
6. 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 
To compare time to first rescue analgesia in sacral ESP block with caudal epidural block
in paediatric lower limb orthopaedic surgery. 
at 30 minutes,2,4,6,8,12
and 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare postoperative pain scores using the FLACC scale at 30 minutes,2,4,6,8,12
and 24 hours
2. To compare postoperative rescue analgesia consumption

3. To compare side effects like nausea, vomiting & lower limb weakness 
30 minutes,2,4,6,8,12 & 24 hours posoperatively 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/09/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 22-07-2025 and end date provided 22-07-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The erector spinae plane block (ESPB) is an interfascial plane block, which appears to be increasing in popularity. Introduced in 2016, primarily to alleviate thoracic neuropathic pain, the indications for the block have been expanding since then.In pediatric surgery, caudal block is a low-cost, simple, and effective procedure for postoperative analgesia and as the only anaesthetic strategy . Caudal block is recommended for most surgical operations in the lower body, primarily below the umbilicus, including lower limb surgeries, inguinal hernia repair, urinary and digestive system surgery. Lower limb is supplied from nerve terminals arising from both sacral (sciatic L4-S3) and lumber (femoral (L2-L4) plexus. Erector spinae muscles overlay on the sacral lamina and continue over the transverse processes of lumbar vertebrae, thus a sacral ESP block performed with an adequate volume will spread in interfacial plane and through sacral foramina blocking both femoral and sciatic nerve, thus providing adequate analgesia for paediatric lower limb surgeries. Caudal block has been successfully used as a part of multimodal analgesic regime in surgeries in paediatric patients. There is a lack of comprehensive research on Sacral erector spinae block in paediatric patients. Effectiveness of sacral ESPB determined by our study will add to the existing body of scientific literature supporting its use as analgesic technique in current practice.No randomised controlled trial has been conducted till date comparing sacral ESPB block to caudal block in paediatric patients. We expect that sacral ESP block will provide analgesia noninferior to caudal block in paediatric patients undergoing lower limb surgeries.
 
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