FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/04/084203 [Registered on: 07/04/2025] Trial Registered Prospectively
Last Modified On: 04/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Analysis of Ultrasound-Guided Sacral Erector Spinae Plane Block and Caudal Epidural Block for pain relief Efficacy in Pediatric Lower Limb Surgery 
Scientific Title of Study   Comparison of the analgesic efficacy of ultrasound guided Sacral Erector Spinae Plane Block with ultrasound guided Caudal epidural Block in paediatric patients undergoing lower limb surgery under general anaesthesia: a randomised controlled study 
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 Nishant Varlani 
Designation  Junior Resident 
Affiliation  AIIMS Bhopal 
Address  Department of Anesthesia and critical care,3rd floor hospital building, AIIMS Bhopal, Saket Nagar Bhopal Madhya Pradesh 462020 India

Bhopal
MADHYA PRADESH
462020
India 
Phone  7793066644  
Fax    
Email  nsvarlani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Zainab Ahmed 
Designation  Additional Professor 
Affiliation  AIIMS Bhopal 
Address  Department of Anesthesia and critical care,3rd floor hospital building,AIIMS Bhopal,Saket Nagar Bhopal Madhya Pradesh 462020 India Bhopal MADHYA PRADESH 462020 India

Bhopal
MADHYA PRADESH
462020
India 
Phone  8860048951  
Fax    
Email  drzainabhaq@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Zainab Ahmed 
Designation  Additional Professor 
Affiliation  AIIMS Bhopal 
Address  Department of Anesthesia and critical care,3rd floor hospital building,AIIMS Bhopal,Saket Nagar Bhopal Madhya Pradesh 462020 India Bhopal MADHYA PRADESH 462020 India


MADHYA PRADESH
462020
India 
Phone  8860048951  
Fax    
Email  drzainabhaq@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, Saket Nagar, Bhopal Madhya pradesh India 462020 
 
Primary Sponsor  
Name  Dr Zainab Ahmed 
Address  Department of Anesthesia and critical care,3rd floor hospital building, AIIMS Bhopal, Saket Nagar Bhopal Madhya Pradesh 462020 India 
Type of Sponsor  Other [self] 
 
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 Nishant Varlani  AIIMS Bhopal  AIIMS Bhopal, Saket Nagar Bhopal Madhya Pradesh 462020 India
Bhopal
MADHYA PRADESH 
07793066644

nsvarlani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Bhopal Instittutional Human Ethics Committee-Student Research(IHEC-SR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Caudal Epidural Block.  After inducing the ptient under general anesthesia, before the incision, local anesthetic will be injected in caudal epidural space in a dose of 0.25% Bupivacaine 1 ml/kg subject to a maximum dose of 2.5 mg/kg of Bupivacaine with 2mcg/kg clonidine. It will take around 10 mins. exact time will be noted. 
Intervention  Sacral Erector Spinae Plane Block  After inducing the patient under general anesthesia, before the incision, local anesthetic will be injected in sacral erector spinae plane in a dose 1ml/kg of 0.25% Bupivacaine subject to a maximum dose of 2.5 mg/kg of Bupivacaine + Clonidine 2 micrograms/kg. It will take around 10 mins. exact time will be noted 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  The study will include all paediatric patients of age 1 years - 9 years, of either sex, ASA(American Society of Anesthesiologists classification of Physical Status) grade I and II undergoing elective or emergency lower limb surgery whose plan of anesthesia is decided as general anesthesia with a regional anesthesia technique. 
 
ExclusionCriteria 
Details  1.Contraindications to regional technique e.g. allergy to local anesthetic drugs, local site infection, sepsis, coagulation disturbance, anatomical abnormalities etc
2.Infants ( because of challenging blocks in this age group).
3.More than 9 years of age (due to the anatomical difficulties expected during caudal epidural block because of progressive ossification of sacrococcygeal ligament making the identification of the sacral hiatus difficult.)
4.Patient with neurological disorders
5.Patient with cutaneous anomalies (angioma, hair tuft, naevus , dimple at the site of block)
6.Inability to identify landmarks.
7.Patients on anti-epileptic drugs or any other enzyme inducers as that would affect the metabolism of the drug.
8.Hypersensitivity/contra-indication to any of the study drugs- local anesthetic or analgesic
9.Patients with polytrauma and patients with fractures of both upper and lower limb. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of post-operative analgesia is defined as the time after surgery within the first 24 hours at which Face, Leg, Activity, Cry and Consolability score (FLACC score) (a validated pain score) more than 4 or a verbal request of analgesics from verbal children.  T0 0 hour
T1 1 hour
T2 2 hours
T3 6 hours
T4 12 hours
T5 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess & compare intraoperative opioid requirement in both the groups defined as total number of doses of fentanyl required.
2.To determine & compare the number & cumulative doses of rescue analgesics in the first 24 hours postoperatively.
3.To determine the fraction of patients requiring rescue analgesics within the first 24 hours postoperatively.
4.To determine Parental Satisfaction Score in both groups at postoperative day 1 (POD1). 
0 hour, 1hour, 2hours, 6hours, 24 hours 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   15/04/2025 
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="6"
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  

Regional anesthesia is now recommended as an adjunct to general anesthesia whenever feasible for its opioid and anesthetic sparing effect. Caudal epidural block (CEB) is one of the most routinely practiced regional anesthetic procedures for intra and post-operative analgesia in paediatric patients. Although complications are rare, adverse effects reported include intravascular, subarachnoid or intraosseous space injection, hypotension (more common in adults), epidural hematoma as well as urinary retention.  USG-guided ESPB is now a common regional anesthetic technique used in clinical practice for a variety of indications including breast reconstruction surgeries, lumbar spine fusion surgeries, post thoracotomy surgeries and hemorrhoidectomy surgeries. In paediatric patients it has shown effective pain control in hypospadias surgery, lower abdominal surgeries, hip surgeries and spine surgeries. It is considered a very safe block and very few adverse effects have been reported till date because the target area that is the vertebral transverse process is an avascular space and is away from all major vital structures and the neuraxis. The various approaches to the ESPB include thoracic, lumbar and sacral depending on the level of the target dermatomes. Sacral ESPB blocks lumbo-sacral dermatomes and is useful for lower abdominal and lower limb surgeries.

On extensive literature review, we could not find any study directly comparing sacral ESPB and caudal epidural block in pediatric patients undergoing lower limb surgery. Therefore, this study to compare sacral ESPB with caudal epidural block has been planned.


 
Close