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CTRI Number  CTRI/2025/05/087962 [Registered on: 30/05/2025] Trial Registered Prospectively
Last Modified On: 22/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ultrasound guided Pericapsular nerve group block vs. Suprainguinal fascia iliaca compartment block in paediatric hip surgery  
Scientific Title of Study   Comparison of ultrasound guided Pericapsular nerve group block versus Suprainguinal Fasia iliaca compartment block in pediatric patients undergoing hip surgery a randomized control 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  Rakesh kumar 
Designation  Pg student  
Affiliation  PGIMER Chandigarh  
Address  Level 4 ,Nehru building , office of Dept of anaesthesia and intensive care,PGIMER Chandigarh ,sec12 ,Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9812371711  
Fax    
Email  Rakeshnehra73@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjay Jaswal  
Designation  ASSOCIATE PROFESSOR  
Affiliation  PGIMER Chandigarh  
Address  Level 4 ,Nehru building , office of Dept of anaesthesia and intensive care,PGIMER Chandigarh ,sec12 ,Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9779170944  
Fax    
Email  Sanjayjaswal247@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanjay Jaswal  
Designation  ASSOCIATE PROFESSOR  
Affiliation  PGIMER Chandigarh  
Address  Level 4 ,Nehru building , office of Dept of anaesthesia and intensive care,PGIMER Chandigarh ,sec12 ,Chandigarh


CHANDIGARH
160012
India 
Phone  9779170944  
Fax    
Email  Sanjayjaswal247@gmail.com  
 
Source of Monetary or Material Support  
PGIMER Chandigarh ,SECTOR 12,Chandigarh,India, Postal code 160012 
 
Primary Sponsor  
Name  Rakesh kumar 
Address  Department of anaesthesia , PGIMER Chandigarh, sec 12 , Chandigarh  
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 RAKESH KUMAR   OT , HOSPITAL   APC OT , PGIMER CHANDIGARH,SEC 12 , CHANDIGARH
Chandigarh
CHANDIGARH 
9812371711

Rakeshnehra73@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE (INTRAMURAL),PGIMER CHANDIGARH   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q659||Congenital deformity of hip, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  USG guided Pericapsular nerve group block (PENG)  Ultrasound-guided Pericapsular Nerve Group (PENG) block, performed under general anaesthesia in pediatric patients. The block involves the administration of 0.4 ml/kg of 0.2% ropivacaine, not exceeding a maximum dose of 2 mg/kg. The ultrasound probe is initially placed transversely over the anterior superior iliac spine (ASIS) and gradually moved to locate the anterior inferior iliac spine (AIIS) and the iliopubic eminence (IPE). After optimal visualization of key anatomical landmarks, including the psoas tendon and iliopsoas muscle, an in-plane needle insertion is performed from lateral to medial, targeting the fascial plane between the psoas tendon and the ilium near the IPE. The local anaesthetic is deposited in this plane to block the articular branches of the femoral, obturator, and accessory obturator nerves, with caution taken to avoid the femoral neurovascular bundle. Interventions are performed by an experienced anaesthesiologist, ensuring consistent technique and blinding throughout the study. 
Comparator Agent  USG guided Suprainguinal fascia iliaca compartment block (SIFICB)  Ultrasound-guided Suprainguinal Fascia Iliaca Compartment Block (SIFICB), also performed under general anaesthesia using the same dose and concentration of ropivacaine (0.4 ml/kg of 0.2% ropivacaine, up to a maximum of 2 mg/kg). In this technique, the ultrasound probe is placed inferior and medial to the ASIS to visualize the iliac crest and iliacus muscle. The fascia iliaca is identified as a hyperechoic line overlying the iliacus muscle. Using an in-plane approach, the needle is advanced laterally to medially, and the local anaesthetic is injected beneath the fascia iliaca but above the iliacus muscle. This technique aims to block the femoral, obturator, and lateral femoral cutaneous nerves. Interventions are performed by an experienced anaesthesiologist, ensuring consistent technique and blinding throughout the study. 
 
Inclusion Criteria  
Age From  18.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Asa 1 ans 2  
 
ExclusionCriteria 
Details  Any history of allergic to any drugs, presence of a congenital heart disease,any renal ,hepatic disease, asa 3 and 4 , local infection and coagulopathy  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare pain between PENG and SIFICB groups using pain score ( FLACC,VAS)  POSTOPERATIVE 24 HRS 
 
Secondary Outcome  
Outcome  TimePoints 
Intraoperative and postoperative opioid consumption    

Total 24 hr of analgesia consumption  
 
Postoperative pain assessment   0,4,8,12,24 hrs 

To assess functional recovery , 
 

Time to first rescue analgesia 
 

Duration of PACU stay  
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
Date of First Enrollment (India)   09/06/2025 
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="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 - NO
Brief Summary  

Comparison of Ultrasound Guided Pericapsular Nerve Group (PENG) Block Versus Suprainguinal Fascia Iliaca Compartment Block (SIFICB) in Paediatric Patients Undergoing Hip Surgery: A Randomised Controlled Trial is a prospective, doubleblind, randomised controlled study conducted by Dr. Rakesh Kumar at PGIMER, Chandigarh. The study is scheduled from March 2025 to May 2026 and will include 60 pediatric patients aged 18 months to 12 years, classified as ASA physical status I or II, who are scheduled for elective hip surgery. The primary aim of the study is to compare the analgesic efficacy of PENG block and SIFICB by evaluating postoperative pain scores using the FLACC or VAS scale at 24 hours. Secondary objectives include assessing intraoperative and postoperative opioid consumption, time to first rescue analgesia, duration of stay in the post-anesthesia care unit (PACU), total 24 hour analgesic use, functional recovery, and complications related to the block procedures.

All patients will undergo general anesthesia and receive either a PENG block or SIFICB using ultrasound guidance with 0.2% ropivacaine (0.4 ml/kg, maximum 2 mg/kg). Pain will be assessed at multiple intervals using FLACC scores for children under 7 and VAS scores for older children. Rescue analgesia with fentanyl, acetaminophen, or ketorolac will be administered as needed. Intraoperative hemodynamics and block effectiveness will also be monitored. Randomization will be achieved through computer-generated numbers and allocation concealment with sealed envelopes. Blinding will be maintained for the anaesthetist assessing outcomes and the surgical team.

 
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