FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/07/034715 [Registered on: 09/07/2021] Trial Registered Prospectively
Last Modified On: 28/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pain relief obtained with ultrasonography guided Pericpasular Nerve group Block ( PENG) versus Femoral Nerve Block ( FNB) in hip fracture patients for sitting position spinal anaesthesia  
Scientific Title of Study   Effect Of ultrasound guided Pericapsular Nerve Group Block (PENG) Vs Femoral Nerve Block (FNB) for analgesia of positioning pain during spinal anaesthesia in hip fracture patients.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jalpa Arvind Kate 
Designation  Consultant Anaesthesiologist 
Affiliation  Bhabha Atomic research Centre Hospital 
Address  Operation theatre complex, Bhabha Atomic research Centre Hospital, Anushakti nagar, Mumbai.

Mumbai (Suburban)
MAHARASHTRA
400094
India 
Phone    
Fax    
Email  jakate@barc.gov.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Jalpa Arvind Kate 
Designation  Consultant Anaesthesiologist 
Affiliation  Bhabha Atomic research Centre Hospital 
Address  Operation theatre complex, Bhabha Atomic research Centre Hospital, Anushakti nagar, Mumbai.


MAHARASHTRA
400094
India 
Phone    
Fax    
Email  jakate@barc.gov.in  
 
Details of Contact Person
Public Query  
Name  Dr Ashok Naik B 
Designation  DNB trainee 
Affiliation  Junior resident , DNB 
Address  Operation theatre complex, Bhabha Atomic research Centre Hospital, Anushakti nagar, Mumbai.

Mumbai (Suburban)
MAHARASHTRA
400094
India 
Phone    
Fax    
Email  doctornaik89@gmail.com  
 
Source of Monetary or Material Support  
Bhabha Atomic Research Centre Hospital, Anushakti Nagar, Mumbai 400094 
 
Primary Sponsor  
Name  Dr Anjali Kulkarni  
Address  Head, Medical division, Bhabha Atomic Research Centre Hospital Anushakti Nagar Trombay Mumbai 400094 
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 Jalpa Arvind Kate  Bhabha Atomic Research Centre Hospital  Main operation theatre, 2nd floor
Mumbai (Suburban)
MAHARASHTRA 		 9820655883

jakate@barc.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medical Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  USG guided Femoral nerve block in hip fracture patients receiving spinal anaesthesia in sitting position.   20ml LA mixture comprising of 10 ml 2% adrenalised lignocaine with 10 ml 0.25% bupivacaine  
Intervention  USG guided Pericapsular Nerve Group Block ( PENG) for pain relief in hip facture patients receiving spinal anaesthesia   20 ml LA mixture comprising 10cc 2% adrenalised lignocaine and 10 ml 0.25% bupivacaine 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult patients (Age >18 years) of ASA Class I, II, III undergoing hip fracture surgery under spinal anaesthesia and willing to participate in the study.

 
 
ExclusionCriteria 
Details  1. Patient refusal.
2. Local skin infection at block site.
3. Patients with difficulty to express pain scores.
4. Neuropsychiatric disorders.
5. Patients having allergy to drugs to be used in the block.
6. Pregnant patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare analgesia using Numerical Rating Scale (NRS) achieved with PENG and FNB at the time of positioning for spinal anaesthesia in patients with hip fractures  Analgesia obtained at the end of 15 minutes after nerve block 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the time taken to perform block, least NRS achieved and duration of post-operative analgesia with PENG & FNB.

 		 1) Total time taken for performing the block. This will be defined as time from lifting the probe to completion of LA injection.
2) check NRS every 5 minutes till 15 minutes. least NRS achieved with either block will be noted
3) Post operatively every 4 hours NRS will be checked. time when NRS more than 4 will be noted ( duration of analgesia) 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/07/2021 
Date of Study Completion (India) 26/05/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 26/05/2022 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   We will be conducting a prospective randomised comparative study to evaluate efficacy of Ultrasonography ( USG) guided Pericapsular nerve group block ( PENG) and Femoral nerve block(FNB) for analgesia of positioning pain during spinal anaesthesia for hip fracture surgery. USG guided PENG and FNB will be performed before spinal anaesthesia in patients undergoing  hip fracture correction. Reduction in pain perceived during spinal anaesthesia positioning will be assessed using Numerical rating scale ( NRS). Both blocks will also be compared with respect to other parameters like time taken to perform block, least NRS achieved and duration of post operative analgesia achieved.
 
Close