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CTRI Number  CTRI/2021/02/031148 [Registered on: 09/02/2021] Trial Registered Prospectively
Last Modified On: 22/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two different types of pain relieving techniques in patients undergoing hip fracture surgery 
Scientific Title of Study   Comparison of continuous pericapsular nerve group block versus continuous fascia iliaca block in patients undergoing hip fracture surgery- a randomized double- blind study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ch Parimal Patel 
Designation  Junior Resident (Postgraduate trainee) 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room 5011, Teaching block, Department of Anaesthesiology, Pain medicine and Critical care All Institute of Medical Sciences, Ansari Nagar East, New Delhi
Room 5011, Teaching block, Department of Anaesthesiology, Pain medicine and Critical care All Institute of Medical Sciences, Ansari Nagar East, New Delhi, 110029
South West
DELHI
110049
India 
Phone  9182030551  
Fax    
Email  dr.parimalpatel@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kanil Ranjith Kumar 
Designation  Assistant Professor 
Affiliation  All Institute of Medical Sciences, New Delhi 
Address  Room 5011, Teaching block, Department of Anaesthesiology, Pain medicine and Critical care All Institute of Medical Sciences, Ansari Nagar East, New Delhi
Room 5011, Teaching block, Department of Anaesthesiology, Pain medicine and Critical care All Institute of Medical Sciences, Ansari Nagar East, New Delhi, 110029
South West
DELHI
110029
India 
Phone  8800314575  
Fax    
Email  kanil.aiims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kanil Ranjith Kumar 
Designation  Assistant Professor 
Affiliation  All Institute of Medical Sciences, New Delhi 
Address  Room 5011, Teaching block, Department of Anaesthesiology, Pain medicine and Critical care All Institute of Medical Sciences, Ansari Nagar East, New Delhi
Room 5011, Teaching block, Department of Anaesthesiology, Pain medicine and Critical care All Institute of Medical Sciences, Ansari Nagar East, New Delhi, 110029
South West
DELHI
110029
India 
Phone  8800314575  
Fax    
Email  kanil.aiims@gmail.com  
 
Source of Monetary or Material Support  
Room 5011, Teaching block, Department of Anaesthesiology, Pain medicine and Critical care All Institute of Medical Sciences, Ansari Nagar East, New Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
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 
Ch Parimal Patel  All Institute of Medical Sciences, New Delhi, Delhi 110029  Room 5011, Department of Anaesthesia, Academic block, AIIMS New Delhi 110029
South West
DELHI 
9182030551

dr.parimalpatel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics committee for postgraduate research, AIIMS  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 
Comparator Agent  Continuous Fascia iliaca block (cFIB)  Under USG guided cFIB with 30 ml 0.25% Ropivacaine followed by 0.2% ropivacaine at 5 ml/hr infusion 
Intervention  Continuous Pericapsular nerve group block (cPENG)  Under USG guided cPENG with 20 ml 0.25% Ropivacaine followed by 0.2% ropivacaine at 5 ml/hr infusion 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1)ASA physical status grade I and II patients
2)Greater than 18 years of age
3)Patients undergoing an operation for neck of femur, sub-capital and intertrochanteric fracture under spinal anaesthesia
 
 
ExclusionCriteria 
Details  1)Patient refusal
2)ASA physical status III and IV
3)Known allergy to local anesthetics
4)Local site infection
5)Severe kidney and liver disease
6)Severe cardiac illness (NYHA Class III and IV)
7)Pre-operative opioid tolerance
8)Intrathecal morphine receivers
9)Postoperative epidural infusion receivers
 
 
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 measure total fentanyl requirements in continuous pericapsular nerve group block versus continuous fascia iliaca block  48 hours post operative 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the following between two groups
1) To assess NRS pain scores at rest and at 15° leg elevation
2) To compare block related adverse events, in terms of local anaesthetic systemic toxicity, hematoma formation and injection site infections.
 
At 0,15 minutes,30 minutes during surgery and 2, 6, 12, 24 and 48 hours post surgery 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   15/02/2021 
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="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)?  

Response - NO
Brief Summary  
Brief Summary:

The aim of the study is to compare the analgesic effect of continuous pericapsular nerve group block (cPENG) and continuous fascia iliaca block (cFIB) in hip fracture patients. The subject and the anaesthetist performing the block will be blinded to the type of block the subject receives. Patients aged 18 years or older with hip fracture scheduled for surgical treatment only under spinal anaesthesia will be assessed for eligibility to participate in the study. Patients with allergy to local anaesthesia, severe medical illness with end-organ damage, ASA physical status Grade III and IV will be excluded from the study trial.

The followings will be assessed: subject’s vitals and numerical rating pain scale before and after nerve block at different time points (15 minutes, 30 minutes and during positioning for spinal anaesthesia). Block success is assessed 30 minutes post nerve block procedure if the patient’s pain score on the numerical rating scale drops by 2 points. Ease of positioning patient for spinal anaesthesia is assessed by a grading score and additional fentanyl requirements needed for positioning is noted. Once the block is given, catheter is inserted in both groups and ropivacaine 0.2% at 5ml/hr infusion is started. All patient will receive paracetamol 1gm, 8hourly for 48 hours post spinal placement.

Patients are monitored post their surgery at regular intervals of 2,6,12,24 and 48 hours to assess their pain scores and to note the additional fentanyl requirements they might need during this time frame. Any breakthrough pain measured with numerical rating scale more than 4 will be treated with 0.5 mcg per kg fentanyl.

 
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