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CTRI Number  CTRI/2023/11/059919 [Registered on: 16/11/2023] Trial Registered Prospectively
Last Modified On: 15/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of pericapsular nerve group block in patients with hip fracture for spinal anaesthesia positioning 
Scientific Title of Study   Effect of pericapsular nerve group block in patients with hip fracture for spinal anaesthesia positioning: A randomized controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prince Bhatia 
Designation  Post graduate resident  
Affiliation  B.J. Medical College Ahmedabad  
Address  Room no E109 Phase 1 Dept of Anaesthesia, BJ Medical College and Hospital, Asarwa, Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  9541488600  
Fax    
Email  prince1996bhatia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Siddharthkumar B Parmar 
Designation  Associate professor 
Affiliation  B.J. Medical College Ahmedabad  
Address  Dept of Anaesthesia, B.J. Medical College and hospital, Asarwa, Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  9426332701  
Fax    
Email  drsid25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prince Bhatia 
Designation  Post graduate resident  
Affiliation  B.J. Medical College Ahmedabad  
Address  Room no E109 Phase 1, Dept of Anaesthesia, BJ Medical College and Hospital, Asarwa, Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  9541488600  
Fax    
Email  prince1996bhatia@gmail.com  
 
Source of Monetary or Material Support  
Dept of Anaesthesia, B.J.Medical College and Civil Hospital Ahmedabad  
 
Primary Sponsor  
Name  Prince Bhatia  
Address  BJ Medical College Asarwa Ahmedabad  
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 
Dr Prince Bhatia   BJ Medical College and Civil Hospital Ahmedabad   Dept of Anaesthesia, BJ Medical College, Asarwa Ahmedabad Gujarat
Ahmadabad
GUJARAT 		 9541488600

prince1996bhatia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee B.J. Medical College and Civil Hospital Ahmedabad   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pericapsular nerve group block followed by spinal anaesthesia in patients with hip fracture  Dose -20 ml 0.5% Ropivacaine, route of administration - Ultrasound guided in musculofascial plane, frequency - 30 minutes before spinal anaesthesia  
Comparator Agent  Spinal anaesthesia in patients with hip fracture   Dose- 3 ml 0.5% Bupivacaine heavy, route of administration - intrathecal 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade I, II, III undergoing elective surgery under spinal anaesthesia.
Unilateral hip fracture surgery under spinal anaesthesia
Willingness of patient
 
 
ExclusionCriteria 
Details  Age <18year and >60 years
Patients having any drug allergy.
Local site infection
Patients having Neuromuscular disorder and neurological symptoms
Patients having coagulation disorder
Pregnancy
Patients having bilateral hip fracture
Patient giving negative consent for procedure
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain profile during positioning for Subarachnoid Block after giving PENG block  Pain profile is measured after 30 minutes of giving PENG block 
 
Secondary Outcome  
Outcome  TimePoints 
Best angle obtained for spinal anaesthesia positioning
Time to CSF flow(sec)
Operator satisfaction
Number of trials for subarachnoid block
Any side effects 		 All outcomes mentioned above are measured after 30 minutes of giving PENG block 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   24/11/2023 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code
    Response - None of the above

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [prince1996bhatia@gmail.com].

  6. For how long will this data be available start date provided 01-03-2025 and end date provided 01-03-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Various peripheral nerve blocks have been described for use in hip fracture and are being used like Femoral nerve block(FNB) and Fascia iliaca compartment block(FICB). FICB sometimes spare femoral nerve and obturator nerve. FNB does not block articular branches of capsule of hip joint. In contrast to these blocks, PENG block targets articular branches of femoral and obturator nerves, also blocks articular branches of hip joint capsule. The PENG block supposedly provide superior dynamic pain relief following fracture neck of femur without causing motor weakness. PENG block has been introduced for analgesia purposes for hip fractures but usefulness of PENG block for spinal anaesthesia positioning has not been elaborated. We therefore decided to study effect of PENG block for spinal anaesthesia positioning. 
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