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CTRI Number  CTRI/2022/11/047757 [Registered on: 29/11/2022] Trial Registered Prospectively
Last Modified On: 24/11/2022
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   Pain management in elderly hip fractures 
Scientific Title of Study   Comparison between Femoral nerve block and Pericapsular nerve group block as Preemptive analgesia in Geriatric hip fractures : A prospective randomised controlled clinical 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 Ajoy Prasad Shetty 
Designation  Senior Consultant,Department of Orthopaedics 
Affiliation  Ganga Medical Centre and Hospitals  
Address  Ganga Hospitals, 313, Mettupalayam Rd, Saibaba Colony, Coimbatore 313, Mettupalayam Rd, Saibaba Colony, Coimbatore, Tamil Nadu
313, Mettupalayam Road , Coimbatore, Tamil Nadu
Coimbatore
TAMIL NADU
641043
India 
Phone  9849182362  
Fax    
Email  ajoyshetty@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dheenadhayalan J 
Designation  Head of Trauma 
Affiliation  Ganga Medical centre and Hospital 
Address  No.3, Gandhinagar, Behind Cheran Nagar, G N Mills Post, Coimbatore 313, Mettupalayam Rd, Saibaba Colony, Coimbatore, Tamil Nadu Coimbatore
313 Mettupalayam Road, Saibaba Kovil, Coimbatore, Tamil Nadu
Coimbatore
TAMIL NADU
641029
India 
Phone  98438726156  
Fax    
Email  dheenu.dhayalan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashutosh Kumar Gupta 
Designation  Primary DNB Candidate,Department of Orthopaedic  
Affiliation  Ganga Medical Centre and Hospitals Pvt. Ltd Address 
Address  2E, Signature Shravana Suites, Venkittapuram, Ambedkar Road, Coimbatore, Tamil Nadu

Coimbatore
TAMIL NADU
641029
India 
Phone  8660022355  
Fax    
Email  ashutoshkumargupta96@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Ganga Medical Centre and Hospitals Pvt Ltd 
Address  313, Mettupalayam Rd, Saibaba Colony, Coimbatore, Tamil Nadu, India 641043  
Type of Sponsor  Private hospital/clinic 
 
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 S Rajasekharan  Ganga Medical Centre and Hospitals Pvt. Ltd  Division of trauma, Department of orthopaedics, Ganga Hospitals, 313, Mettupalayam Rd, Saibaba Colony
Coimbatore
TAMIL NADU 		 9843022325

rajasekaran.orth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRB ORTHOPAEDICS  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: S721||Pertrochanteric fracture,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Femoral nerve block group  This study proposes to include patients aged more than 65 years identified to have either intertrochanteric fracture or neck of femur fracture. They will be be initially checked if they meet the inclusion criteria and upon that will be included in study. They will be divided into two groups either Femoral nerve group or Pericapsular nerve group block according to Computer generated randomisation. Participants receiving the Femoral nerve block are the comparator group. They will undergo block administration on arrival. Their pain assessment (according to VAS scale) and vitals monitoring would be done at regular intervals. They will receive block again in immediate preoperative period and then will be taken up for surgery. Their pain assessment , vitals monitoring and muscle strength would be assessed at regular intervals 
Intervention  Pericapsular nerve group block group  This study proposes to include patients aged more than 65 years identified to have either intertrochanteric fracture or neck of femur fracture. They will be be initially checked if they meet the inclusion criteria and upon that will be included in study. They will be divided into two groups either Femoral nerve group or Pericapsular nerve group block according to Computer generated randomisation. Participants receiving the Pericapsular nerve group block are the intervention group. They will undergo block administration on arrival. Their pain assessment (according to VAS scale) and vitals monitoring would be done at regular intervals. They will receive block again in immediate preoperative period and then will be taken up for surgery. Their pain assessment , vitals monitoring and muscle strength would be assessed at regular intervals 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients with Neck of femur and intertrochanteric fracture above 65 years of age will be included in the study 
 
ExclusionCriteria 
Details  Patients with polytrauma, open fractures, fractures with subtrochanteric extension, non-ambulatory patients, unable to communicate, patients having history of opioid abuse, patients currently on opioid medication and patients who do not consent for the study will be excluded from the study 
 
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 reduction in pain would be done using VAS scoring, opioid use will be calculated in terms of milliequivalents of morphine, muscle strength will be calculated according to MRC grading, duration of hospital stay will be calculated and compared between participants receiving Femoral nerve block and Pericapsular nerve group block  Assessment to be done till discharge of patient from hospital 
 
Secondary Outcome  
Outcome  TimePoints 
Blood loss during surgery, Ease of positioning patient during surgery, Incidence of Delirium in post operative period will be assessed  Assessment of reduction in pain would be Assessment to be done till discharge of patient from hospital 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   01/12/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
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-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ashutoshkumargupta96@gmail.com].

  6. For how long will this data be available start date provided 27-10-2024 and end date provided 27-10-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study proposes to include patients aged more than 65 years identified to have either intertrochanteric fracture or neck of femur fracture. They will be initially checked if they meet the inclusion criteria and upon that will be included in the study. They will be divided into two groups either Femoral nerve group or Pericapsular nerve group block according to Computer generated randomization. They will undergo block administration on arrival according to their group. Their pain assessment (according to VAS scale) and vitals monitoring would be done at regular intervals. They will undergo surgical management for the fracture. They will receive block again in the preoperative period according to the earlier decided group. Their pain assessment, vitals monitoring and muscle strength would be done at regular intervals. Other complications such as post-operative onset delirium would be assessed. Finally total opioid administration during their stay, and duration of hospital stay would be assessed. Results will be analyzed to know whether Femoral nerve block is better than the Pericapsular nerve group block as preemptive analgesia in Geriatric hip fracture patients. This would help us to better understand the role of the block as preemptive analgesia in Geriatric hip fracture patients 
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