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CTRI Number  CTRI/2025/08/093105 [Registered on: 14/08/2025] Trial Registered Prospectively
Last Modified On: 04/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the post operative pain reduction between two interventional nerve block techniques in the participants involving the patients undergoing hip surgeries and analyzing their outcomes 
Scientific Title of Study   Comparing the postoperative analgesic effect between the ultrasound guided Pericapsular Nerve Group PENG block and Fascia Iliaca Compartment Block FICB in intertrochanteric hip fracture surgeries  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Palani Sukumar 
Designation  Junior Resident 
Affiliation  Esic Medical College and Hospital 
Address  Department of Anaesthesiology,B block, 1st floor,Modular OT, Esic Medical College and Hospital, Ashok Pillar Main Rd,KK Nagar,Chennai,Tamilnadu

Chennai
TAMIL NADU
600078
India 
Phone  9361349906  
Fax    
Email  sukuvinoth@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aswini L 
Designation  Associate Professor 
Affiliation  Esic Medical College and Hospital 
Address  Department of Anaesthesiology,B block, 1st floor,Modular OT, Esic Medical College and Hospital, Ashok Pillar Main Rd,KK Nagar,Chennai,Tamilnadu

Chennai
TAMIL NADU
600078
India 
Phone  9442011352  
Fax    
Email  aswini.mbbs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aswini L 
Designation  Associate Professor 
Affiliation  Esic Medical College and Hospital 
Address  Department of Anaesthesiology,B block, 1st floor,Modular OT, Esic Medical College and Hospital, Ashok Pillar Main Rd,KK Nagar,Chennai,Tamilnadu

Chennai
TAMIL NADU
600078
India 
Phone  9442011352  
Fax    
Email  aswini.mbbs@gmail.com  
 
Source of Monetary or Material Support  
ESIC MEDICAL COLLEGE AND HOSPITAL,ASHOK PILLAR MAIN ROAD,KK NAGAR,CHENNAI 
 
Primary Sponsor  
Name  Esic Medical College and Hospital 
Address  B block, 1st floor, Department of Anaesthesiology,Ashok Pillar Main Road, KK Nagar,Chennai 600078 
Type of Sponsor  Government medical college 
 
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 
SUKUMAR  ESIC MEDICAL COLLEGE AND HOSPITAL  B block , 1st floor, Department of Anaesthesiology, Operating Room no 3,4 .
Chennai
TAMIL NADU 
9361349906

sukuvinoth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Esic medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fascia Iliaca Compartment Block under Ultrasound guidance  30 ml local anesthetic injected with 0.25 percent bupivacaine (28 ml) and 8 mg of Dexamethasone (2 ml)  
Intervention  Pericapsular Nerve Group Block under Ultraound guidance  30 ml of local anesthetic 0.25percent bupivacaine (28 ml) and 8 mg of dexamethasone (2 ml) 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients of age 40 to 70 years old who underwent isolated intertrochanteric fracture surgeries provided written consent
Both sex
Belonging to
ASA 1 ASA 2 and 3 physical status 
 
ExclusionCriteria 
Details  Patient refusal for PENG or FICB
Patients who are not cooperative
Revision surgeries
Known allergies to local anaesthetics
Infection at the site of injection
ASA physical status of 4 and above  
 
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 postoperative analgesic effect between PENG (pericapsular nerve
group block) and FICB (fascia iliaca compartment block) in intertrochanteric hip
fracture surgeries via the visual analog scale (VAS)  
30 minutes to 24 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the time of first request of rescue analgesia between pericapsular nerve group block
and fascia iliac compartment block.  
0 minutes to 24 hours 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 2 
Date of First Enrollment (India)   15/08/2025 
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="11"
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  

This randomized double blinded clinical trial will be conducted at ESIC Medical College and Hospital Chennai, after approval from the institutional ethics committee. Informed written consent will be obtained from all the participants of the study. All the patients scheduled for elective intertrochanteric hip fracture surgeries between the age group 40 to 70 years of either sex  belonging to ASA 1,2 and 3 will be included in the study. On the day of surgery, spinal anaesthesia will be given for the surgery as per standard institutional protocol. Randomization will be done by a computer-generated table of random numbers. The allocation list will be generated and concealed in sealed envelopes. One envelope will be opened for each eligible candidate and the patient will be allocated to one of the two groups. The patient and the principal investigator will be blinded to this study. An Anaesthesiologist trained in these blocks will be performing the procedure. After surgery, under sterile aseptic precautions, patients in the Group A will receive an ultrasound guided pericapsular nerve group block using 0.25 percentage bupivacaine 28 ml and 8 mg of dexamethasone 2 ml. Patients in the Group B will receive an ultrasound guided Fascia Iliac compartment block using 0.25 percentage bupivacaine 28 ml, and 8 mg of dexamethasone 2 ml. Once the regional block is complete the patient will be shifted to the PACU post anaesthesia care unit for further observation. The study will start from the time the patient is shifted to PACU. The postoperative analgesia effect and other parameters such as heart rate, blood pressure, oxygen saturation spo2, first time of rescue analgesia, total opioid consumption, adverse effects, degree of range of motion by HARRIS HIP SCORE  at 0min, 15 min,30min,1 hour,2 hrs, 4hrs,8hrs,12 hrs and 24hrs after blockade. The injection of tramadol 1mg per kg mg intravenous sos will be considered as rescue analgesia if Visual Analogue Scale more than 4. Nausea, which is one of the most common side effects of tramadol, will be treated with injection Ondansetron 0.1 mg per kg  intravenous.

 
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