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
|
|
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
|
|
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. |