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CTRI Number  CTRI/2025/11/096783 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 02/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing Two Types of Nerve Blocks (PENG and Supra-inguinal Fascia Iliaca) for Pain Relief and Muscle Strength After Hip Surgery 
Scientific Title of Study   Peng block vs. supra-inguinal fascia iliaca block: a comparative analysis of analgesia duration and motor blockade in hip surgery patients 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  G Sada Shiva Reddy 
Designation  Postgraduate Resident  
Affiliation  Armed Forces Medical College 
Address  14/A, Old Golibar Maidan, Camp, Pune
Southern Command, Solapur-Pune hwy, Near Race Course, Wanowrie, Pune, Maharashtra
Pune
MAHARASHTRA
411037
India 
Phone  9003126126  
Fax    
Email  sadashivreddy3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Aditya Sapra 
Designation  Head of Department 
Affiliation  Armed Forces Medical College 
Address  Department of Anaesthesiology, Armed Forces Medical College, Southern Command, Solapur-Pune hwy, Near Race Course, Wanowrie, Pune, Maharashtra
Southern Command, Solapur-Pune hwy, Near Race Course, Wanowrie, Pune, Maharashtra
Pune
MAHARASHTRA
411040
India 
Phone  8197084270  
Fax    
Email  adityaspara@gmail.com  
 
Details of Contact Person
Public Query
 
Name  John M K 
Designation  Associate Professor 
Affiliation  Armed Forces Medical College 
Address  Department of Anaesthesiology, Armed Forces Medical College, Southern Command, Solapur-Pune hwy, Near Race Course, Wanowrie, Pune, Maharashtra
Southern Command, Solapur-Pune hwy, Near Race Course, Wanowrie, Pune, Maharashtra
Pune
MAHARASHTRA
411040
India 
Phone  9765167438  
Fax    
Email  majjohnmk9090@gmail.com  
 
Source of Monetary or Material Support  
Armed Forces Medical College, Southern Command, Solapur-Pune hwy, Near Race Course, Wanowrie, Pune, Maharashtra, 411040 
 
Primary Sponsor  
Name  G Sada Shiva Reddy 
Address  Department of Anaesthesiology, Armed Forces Medical College, Southern Command, Solapur-Pune hwy, Near Race Course, Wanowrie, Pune, Maharashtra  
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 
John M K  Armed Forces Medical College  Department of Anaesthesiology, 1st floor, Southern Command, Solapur-Pune hwy, Near Race Course, Wanowrie, Pune, Maharashtra
Pune
MAHARASHTRA 
9765167438

majjohnmk9090@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECAFMCPUNE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S720||Fracture of head and neck of femur,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A will receive the Pericapsular Nerve Group (PENG) block  Will be performed preoperatively under ultrasound guidance by trained anesthesiologists. For the PENG block, 25 ml of 0.25 ropivacaine will be administered targeting the pericapsular region between the psoas tendon and pubic ramus. For the SIFI block, 25 ml of 0.25 ropivacaine will be deposited in the supra-inguinal plane deep to the fascia iliaca, aiming for spread toward the femoral, lateral femoral cutaneous, and obturator nerves. Postoperatively, patients will be assessed for pain using the Visual Analog Scale (VAS) at regular intervals (0, 4, 8, 12, and 24 hours). 
Comparator Agent  Group B will receive the Supra-inguinal Fascia Iliaca (SIFI) block  Will be performed preoperatively under ultrasound guidance by trained anesthesiologists. For the PENG block, 25 ml of 0.25 ropivacaine will be administered targeting the pericapsular region between the psoas tendon and pubic ramus. For the SIFI block, 25 ml of 0.25 ropivacaine will be deposited in the supra-inguinal plane deep to the fascia iliaca, aiming for spread toward the femoral, lateral femoral cutaneous, and obturator nerves. Postoperatively, patients will be assessed for pain using the Visual Analog Scale (VAS) at regular intervals (0, 4, 8, 12, and 24 hours). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients aged 18 to 80 years.
ASA Physical Status I to III.
Scheduled for hip surgery (e.g., fracture fixation or arthroplasty).
Able to provide informed consent
 
 
ExclusionCriteria 
Details  Allergy to local anesthetics.
Coagulopathy or on anticoagulant therapy.
Infection at the block site.
Pre-existing motor/sensory deficit in lower limbs.
Cognitive impairment interfering with pain scoring.
 
 
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 
Duration of Analgesia (in hours)
Degree of Motor Blockade 
0, 2, 4, 8, 12, and 24 hours postoperatively.
 
 
Secondary Outcome  
Outcome  TimePoints 
Pain Scores at Defined Intervals
Time to First Rescue Analgesia
Total Rescue Analgesic Consumption
Patient Satisfaction Score
Time to First Ambulation
Incidence of Adverse Effects or Complications 
0, 2, 4, 8, 12, and 24 hours postoperatively 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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/ Phase 4 
Date of First Enrollment (India)   01/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/12/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="3"
Days="1" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Hip fractures and surgeries in the elderly are associated with significant morbidity and mortality. Optimal pain control is crucial in perioperative management, facilitating early mobilization, reducing complications such as deep vein thrombosis and pulmonary embolism, and improving overall outcomes. Regional anesthesia techniques are frequently employed to provide effective analgesia while preserving motor function.
The Pericapsular Nerve Group (PENG) block and Supra-inguinal Fascia Iliaca Block (SIFI) have gained attention for hip surgery analgesia. The PENG block, a newer technique, specifically targets articular branches of the femoral, obturator, and accessory obturator nerves innervating the anterior hip capsule. Performed under ultrasound guidance, it is designed to spare motor nerves, minimizing quadriceps weakness. This motor-sparing property is particularly advantageous in elderly patients, allowing early physiotherapy and ambulation.
The SIFI block, a modification of the traditional fascia iliaca block, involves a higher injection site to facilitate spread toward the lumbar plexus. It provides broad coverage of the femoral, lateral femoral cutaneous, and obturator nerves. While offering robust analgesia, it has higher potential for motor blockade due to extensive nerve involvement, particularly affecting the quadriceps, which may delay postoperative mobilization.
Despite growing utilization, there is lack of consensus regarding their comparative efficacy. Current literature presents conflicting results, with most studies limited by small sample sizes or heterogeneous methodologies.
Our study aims to compare the PENG block versus SIFI block in hip surgery patients. Primary endpoints include analgesia duration, measured using standardized pain scores and time to first rescue analgesia, and degree of motor blockade assessed through objective motor function scales. Secondary outcomes include patient satisfaction, ease of administration, and incidence of complications.
Understanding these techniques’ differential effects is crucial for guiding anesthesiologists toward the most appropriate block based on individual patient needs. In an aging population where functional preservation is as important as pain control, selecting a block providing effective analgesia without compromising mobility is essential
 
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