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CTRI Number  CTRI/2019/04/018654 [Registered on: 18/04/2019] Trial Registered Prospectively
Last Modified On: 04/11/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Analgesic efficacy of Pre-Emptive USG guided Pericapsular Nerve Group (PENG) block vs Femoral nerve block vs articular branch block while positioning the patient during neuraxial anaesthesia for unilateral hip fracture surgery 
Scientific Title of Study   A Comparative Study of analgesic efficacy of Pre-Emptive USG guided Pericapsular Nerve Group (PENG) block vs Femoral nerve block vs articular branch block while positioning the patient during neuraxial anaesthesia for unilateral hip fracture surgery- A Prospective Randomised Comparative 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 Kartik Sonawane 
Designation  Consultant Anaesthesiologist  
Affiliation  Ganga Medical Centre and Hospital Private Limited  
Address  Ganga Medical Centre and Hospital Private Limited Dept of Anaesthesia 313 Mettypallyam Road Coimbatore

Coimbatore
TAMIL NADU
641043
India 
Phone  9561840842  
Fax    
Email  drkartiksonawane@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kartik Sonawane 
Designation  Consultant Anaesthesiologist  
Affiliation  Ganga Medical Centre and Hospital Private Limited  
Address  Ganga Medical Centre and Hospital Private Limited Dept of Anaesthesia 313 Mettypallyam Road Coimbatore

Coimbatore
TAMIL NADU
641043
India 
Phone  9561840842  
Fax    
Email  drkartiksonawane@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kartik Sonawane 
Designation  Consultant Anaesthesiologist  
Affiliation  Ganga Medical Centre and Hospital Private Limited  
Address  Ganga Medical Centre and Hospital Private Limited Dept of Anaesthesia 313 Mettypallyam Road Coimbatore

Coimbatore
TAMIL NADU
641043
India 
Phone  9561840842  
Fax    
Email  drkartiksonawane@gmail.com  
 
Source of Monetary or Material Support  
Ganga Medical Centre and Hospital Private Limited Dept of Anaesthesia 313, Mettupallyam Road Coimbatore 641043 Tamil Nadu 
 
Primary Sponsor  
Name  Ganga Medical Centre and Hospital Private Limited  
Address  313 Mettypallyam Road Coimbatore 
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 Kartik Sonawane  Ganga Medical Centre and Hospital Private Limited   Dept of Anaesthesia 313 Mettypallyam Road Coimbatore
Coimbatore
TAMIL NADU 		 9561840842

drkartiksonawane@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board (Anaesthesia) Ganga Medical Centre and Hospital Private Limited   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, (2) ICD-10 Condition: S721||Pertrochanteric fracture, (3) ICD-10 Condition: S722||Subtrochanteric fracture of femur, (4) ICD-10 Condition: S39||Other and unspecified injuries ofabdomen, lower back, pelvis and external genitals,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Per-Emptive Femoral Nerve block  Ultrasound Guided Femoral Nerve Block given to the patient in the Preop holding area before shifting to OT Using 20 cc of 0.2% Ropivacaine/0.25% Bupivacaine of plus 8 mg Dexamethazone 
Comparator Agent  Pre-Emptive Femoral Articular Branch Block  Ultrasound Guided Femoral Articular Branch Block given to the patient in the Preop holding area before shifting to OT Using 20 cc of 0.2% Ropivacaine/0.25% Bupivacaine of plus 8 mg Dexamethazone 
Comparator Agent  Pre-Emptive PENG Block  Ultrasound Guided PENG Block given to the patient in the Preop holding area before shifting to OT Using 20 cc of 0.2% Ropivacaine/0.25% Bupivacaine of plus 8 mg Dexamethazone 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients with Unilateral hip fractures like,
NOF fracture,
IT Fracture,
ST fracture,
ACETABULAR fracture
Patient who already received/ not received on arrival Block for unilateral hip fracture 
 
ExclusionCriteria 
Details  Patient Refusal,
Polytrauma Patient,
Allergic to LA,
Patient with Cognitive dysfunction
Age less than 10 yrs or more than 90 yrs
Patient with mental illness
Bilateral hip fractures
Patient not fit for Neuraxial anaesthesia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Analgesic Efficacy of Pre-Emptive Block   Rest / Dynamic VAS score (0-10) at 0, 5,10,15,20,25,30 minutes after giving block or before shifting to OT whichever is earlier 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of patient positioning for Neuraxial anaesthesia inside OT  (0-3) 0- worst, 1- Bad, 2- Good, 3- Best 
Assistants required for patient Positioning  1,2,3,4, more than 4 
Patient Acceptance  Yes or No 
Time taken for Neuraxial Anaesthesia  Time from supine position inside OT before Neuraxial anaesthesia till Supine position after Neuraxial anaesthesia in minutes 
Pain score inside OT after Pre-Emptive Block  VAS score (0-10) in Supine position
VAS Score (0-10) in Sitting Position 
Active Hip Flexion inside OT after Pre-Emptive Block  0, 15,30,45,90, more than 90 degrees 
Opioid consumption for positioning patient for Neuraxial anaesthesia inside OT  Yes or No 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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   N/A 
Date of First Enrollment (India)   20/04/2019 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Hip fracture is associated with Significant Pain. There are lot of described regional anaesthesia/ analgesia techniques described for hip fracture. These blocks can be given as an On-Arrival Block ( given immediately once patient arrives in the hospital) as well as Pre-Emtive Block (given before shifting patient inside OT for positioning patient for Neuraxial procedures).
In our study we are comparing analgesic efficacy of Femoral Nerve Block with Articular Branch Block with PENG Block which are given as Pre-Emptive Block in the Preop holding area before shifting patient inside OT. We presume that these Block will help patient to tackle pain during positioning for Neuraxial procedure inside OT. Also, these blocks will decrease total time required in Neuraxial procedure by helping patient positioning with adequate assistants with tolerable or little amount of Pain.
Inclusion Criteria:
Age 10-90 yrs patient with
Unilateral hip fracture which includes,
NOF FRACTURE,
IT Fracture,
ST Fracture,
ACETABULAR fracture,
Patients who received on-arrival Block also included in this study to compare nature of pain
 
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