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CTRI Number  CTRI/2020/07/026448 [Registered on: 09/07/2020] Trial Registered Prospectively
Last Modified On: 09/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of perioperative efficacy of analgesia and spinal position between the ultrasound guided PENG block and SIFI block in hip surgeries 
Scientific Title of Study   Comparative efficacy of peri-operative analgesia and ease of spinal position between ultrasound guided Pericapsular Nerve Group (PENG) block and Supra Inguinal Fascia Iliaca (SIFI) block in hip surgeries – A double blinded randomized controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Basavaraja 
Designation  Assistant professor, MD, DNB (Anaesthesiology) 
Affiliation  S Nijalingappa Medical College Navanagar Bagalkot 587102 
Address  Department of anaesthesiology major OT complex S N Medical college and HSK Hospital Navanagar Bagalkot Bagalkot KARNATAKA 587102 India

Bagalkot
KARNATAKA
587102
India 
Phone  9886334039  
Fax    
Email  basavarajapothnal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Basavaraja 
Designation  Assistant professor, MD, DNB (Anaesthesiology) 
Affiliation  S Nijalingappa Medical College Navanagar Bagalkot 587102 
Address  Department of anaesthesiology major OT complex S N Medical college and HSK Hospital Navanagar Bagalkot Bagalkot KARNATAKA 587102 India

Bagalkot
KARNATAKA
587102
India 
Phone  9886334039  
Fax    
Email  basavarajapothnal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Naveen R 
Designation  Resident in Anaesthesiology Dept 
Affiliation  S Nijalingappa Medical College Navanagar Bagalkot 587102 
Address  Department of anaesthesiology major OT complex S N Medical college and HSK Hospital Navanagar Bagalkot Bagalkot KARNATAKA 587102 India

Bagalkot
KARNATAKA
587102
India 
Phone  9916588994  
Fax    
Email  nandaraginaveenr@gmail.com  
 
Source of Monetary or Material Support  
Major OT Complex 2nd floor Department of anaesthesia S N Medical College and HSK Hospital Navanagar Bagalkot 
 
Primary Sponsor  
Name  S Nijalingappa Medical College and HSK Hospital 
Address  S N Medical college and HSK Hospital Navanagar Bagalkot 587102 
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 Basavaraja  S Nijalingappa Medical College and HSK Hospital   Department of Anaesthesiology 2nd Floor Major OT complex. Bagalkot KARNATAKA
Bagalkot
KARNATAKA 		 9886334039

basavarajapothnal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SNMC_INSTITUTIONAL ETHICS COMMITTEE ON HUMAN SUBJECTS RESEARCH  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  Comparison of analgesia between Ultrasound guided periencapsular nerve group block versus ultrasound guided suprainguinal fascia iliac block  Comparative efficacy of perioperative analgesia and ease of spinal position between ultrasound guided Pericapsular Nerve Group (PENG) block and Supra Inguinal Fascia Iliaca (SIFI) block these done through regional block route in hip surgeries 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA I–Ⅲ patients
Body mass index ≤30 kg/m2
Patients undergoing elective hip surgeries like femur neck intertrochanteric and subtrochanteric fracture
 
 
ExclusionCriteria 
Details  Patient refusal to give consent.
Infection at site of injection.
Allergy to local anaesthetics.
Patients receiving opioids for chronic analgesic therapy.
Coagulopathy
Patients with inguinal hernia on the same side of hip pathology
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of perioperative analgesia by numerical rating scale (NRS) between two study groups at rest and straight leg raise of affected limb to 15 degrees
 		 NRS pain score 30 minutes before and after administration of block
 
 
Secondary Outcome  
Outcome  TimePoints 
Ease of spinal position between two groups by using ease of spinal position scale (EOSP).
Comparison of amount of consumption of rescue analgesia between two groups.
Observation of any complications during the study.
 		 Every 2 hourly after performing block 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   10/07/2020 
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="0"
Months="6"
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)?  

Brief Summary   The objective of this randomized control study is comparison of analgesic efficacy and ease of spinal position between ultrasound guided pericapsular nerve group block versus suprainguinal fascia iliac block for patients posted to hip surgeries.  
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