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CTRI Number  CTRI/2021/01/030612 [Registered on: 20/01/2021] Trial Registered Prospectively
Last Modified On: 13/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the effectiveness of two nerve blocks which help patient to sit during spinal anaesthesia during surgery for hip fracture. 
Scientific Title of Study   Comparison of preoperative ultrasound guided peri capsular nerve group block and femoral nerve block for facilitating positioning prior central neuraxial blockade in patients undergoing hip fracture surgery- a randomised controlled pilot 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 Athul C A 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences,Ansari nagar, New Delhi
Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences,Ansari nagar, New Delhi
South
DELHI
110029
India 
Phone  7907897736  
Fax    
Email  athulca001@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Darlong V 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi
room no:5018,department of anaesthesiology,5th floor,academic block,ansari nagar,new delhi,110029
South
DELHI
110029
India 
Phone  9868397809  
Fax    
Email  darlongv@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Darlong V 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi
room no:5018,department of anaesthesiology,5th floor,academic block,ansari nagar,new delhi,110029
South
DELHI
110029
India 
Phone  9868397809  
Fax    
Email  darlongv@yahoo.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences 
 
Primary Sponsor  
Name  AIIMS 
Address  Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 
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 
Athul C A  AIIMS  Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
South
DELHI 		 7907897736

athulca001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Intitute ethics committee,All India Institute of Medical Sciences  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: 4||Measurement and Monitoring, (3) ICD-10 Condition: 4||Measurement and Monitoring, (4) ICD-10 Condition: O||Medical and Surgical, (5) ICD-10 Condition: S721||Pertrochanteric fracture,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  femoral nerve block group  femoral nerve block will be given with 20 ml of 0.25% bupivacine 
Intervention  pericapsular nerve group block   pericapsular nerve group will be given with 20 ml 0.25% bupivacaine  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  Patient with age above 18 years, posted for surgical repair of
1. Neck of femur fracture
2. Inter trochanteric fracture 
 
ExclusionCriteria 
Details  Patient refusal
Any contraindication to neuraxial blockade
Known allergy to local anesthetic drugs
Peripheral neuropathy
Hemodynamically unstable polytrauma patients
Patients with any pelvic fractures
ï‚· Patients who are ASA 4 and above 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
heart rate,blood pressure,VAS score,sitting angle and patient positioning score  baseline(prior to intervention)and 30 minutes after the block 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of patient positioning by a subjective patient positioning score  30 minutes after the block under study(while doing central neuraxial blockade) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   26/01/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   In this study we are comparing USG guided pericapsular nerve group block (PENG) with USG guided femoral nerve block (FNB) for improving positioning before central neuraxial block in patients undergoing surgery for neck of femur and inter trochanteric fracture.Single blinded randomized controlled pilot study with sample size of 30.two groups are taken in the study,Group P (PENG) and Group F (FNB).baseline vitals,VAS score and sitting angle will be measured.Each group will be give respective USG guide blocks with 20 ml of 0.25% bupivacaine.parameters are again measured 30 minutes after the block,while attemptin positioning for central neuraxial block.after positioning,patient position score is obtained.Use fentanyl if positioning is difficult.if positioning is not at all possible,covert the procedure to general anaesthesia and proceed futher. 
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