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CTRI Number  CTRI/2023/04/051388 [Registered on: 06/04/2023] Trial Registered Prospectively
Last Modified On: 24/07/2024
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   Ultrasound guided Errector spinae plane block vs caudal epidural block for postoperative pain relief in children 
Scientific Title of Study   Ultrasound-Guided sacral erector spinae plane block versus caudal epidural block for postoperative analgesia in children undergoing hypospadias surgery: Randomized controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harishchandra Gupta  
Designation  Junior resident (PG-JR) 
Affiliation  Junior resident (PG-JR),AIIMS raipur 
Address  B block or complex 4th floor, B block AIIMS Raipur, Tatibandh, Raipur, Chhattisgarh 492099

Raipur
CHHATTISGARH
492009
India 
Phone    
Fax    
Email  harishgp2011@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mayank Kumar  
Designation  Associate Professor  
Affiliation  Associate Professor, Department of Anaesthesiology, AIIMS raipur 
Address  Department of Anaesthesiology AIIMS Raipur, Tatibandh, Raipur, Chhattisgarh 492099

Raipur
CHHATTISGARH
492099
India 
Phone    
Fax    
Email  mayanksonupmch@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mayank Kumar  
Designation  Associate Professor  
Affiliation  Associate Professor, Department of Anaesthesiology, AIIMS raipur  
Address  Department of Anaesthesiology AIIMS Raipur, Tatibandh, Raipur, Chhattisgarh 492099

Raipur
CHHATTISGARH
492099
India 
Phone    
Fax    
Email  mayanksonupmch@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Raipur medical college  
 
Primary Sponsor  
Name  AIIMS Raipur 
Address  Gate No, 1, Great Eastern Rd, opposite Gurudwara, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099 
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 Harishchandra Gupta   AIIMS Raipur  AIIMS Raipur, GE road B block OT complex, 4th floor, AIIMS Raipur, Tatibandh, Raipur Chhattisgarh - 492099
Raipur
CHHATTISGARH 
9664566706

harishgp2011@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institute Ethics Committee, AIIMS Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q549||Hypospadias, unspecified, (2) ICD-10 Condition: Q549||Hypospadias, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Caudal epidural block  1 ml/kg of 0.25% Bupivacaine And observed for 24 hr 
Intervention  Ultrasound-Guided sacral erector spinae plane block   1 ml/kg of 0.25% Bupivacaine under USG guided ESP observed for 24 hours  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  6.00 Year(s)
Gender  Male 
Details  from 1 yr of age to 6 yr of age 
 
ExclusionCriteria 
Details  Patients parents refusal
Patients with any contraindications to regional anaesthesia
History of development delay or mental retardation, which will make observational pain intensity assessment difficult
History of allergic reaction to local anaesthetic
Rash or skin infection at the site of injection
Anatomical abnormalities
Bleeding diathesis
Coagulation disorder
History of renal, hepatic, cardiac disorder, upper or lower infection or any neurological abnormalities  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Postoperative pain intensity by FLACC scale   Postoperative pain intensity by FLACC scale  
 
Secondary Outcome  
Outcome  TimePoints 
Total analgesic requirement
It is the duration required for 1st rescue postoperative analgesia
Hemodynamic- Heart rate, Systolic and Diastolic blood pressure and Oxygen saturation recorder before the block, every 10 minutes after caudal block and 15 minutes after recovery
Parents satisfaction on postoperative day 1[0- No satisfaction,10- Total satisfaction] 
Rescue analgesics and parents satisfaction  
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/04/2023 
Date of Study Completion (India) 10/06/2024 
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    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Hypospadias occurs in 1 in 200 new born males and its correction is one of the most common Urological surgeries performed in children [1]. Various methods and medications that have Been tried to provide postoperative pain relief in the paediatric population can be associated Side effects. Use of opioid in paediatrics shows somnolence, vomiting and also respiratory Depression as an alarming side effect [2].Regional analgesia utilized for this penile reconstructive surgery is typically either a caudal Or dorsal penile nerve block. Caudal blocks are the most commonly performed blocks in Children undergoing pelvic genitourinary surgery and are frequently performed for Hypospadias surgery [3].Caudal injection through the sacral hiatus is easy to perform. For most of the year’s caudal Block is considered to be effective in further prolonging postoperative analgesia. However,Variations in sacral anatomy, the potential for coagulopathy and the possible infection risks Contribute to the complexity of application and success of the block. Caudal block may also Lead to some complications like motor block, urinary retention, block failure, blood Aspiration, and intra- vascular injection. [2]Nowadays, the use of ultrasound (US)-guided nerve block resulted in the revolutionary Change in the field of regional anaesthesia in paediatrics. Many truncal blocks are used for Both upper and lower abdominal surgeries with a high success rate [4]. Nerve blockade has Been shown to be as effective as caudal block for infra umbilical surgeries. Recent literature Suggests that, as an alternative method, peripheral nerve blocks have longer analgesia Duration and fewer adverse effects than neuraxial blocks [5,6]Erector spinae plane block (ESPB) was first described by Foreroin 2016 as an interfascial 
plane block which was 1st performed at the upper thoracic levels for the treatment of thoracic neuropathic pain; eventually it was used in lower thoracic and lumbar levels.ESP block carries promise as a simpler and safer alternative to caudal block. The efficacy of this technique for the management of acute and chronic pain in the thoracic region is reported to be effective [7,8]. Case reports on sacral ESP block states that sacral erector spinae plane block provides surgical anaesthesia in ambulatory anorectal surgery [18].ESP block when used in paediatric patients presenting for hip surgery improved the postoperative analgesia. Therefore, we consider that in sacral region, it may have the same anatomical considerations to get good result.

 
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