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CTRI Number  CTRI/2025/05/086994 [Registered on: 15/05/2025] Trial Registered Prospectively
Last Modified On: 28/04/2025
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   Comparison of pericapsular nerve group block and fascia iliaca compartment block for analgesia after hip fracture surgery 
Scientific Title of Study   A randomized comparative study to evaluate pre operative and post operative analgesic effect of ultrasound guided pericapsular nerve group block Vs fascia iliaca block in patients undergoing elective hip fracture surgery in Department of Anaesthesiology, SMS Medical College and Attached Hospitals, Jaipur 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohamed Eshan P 
Designation  MD 3rd year 
Affiliation  SMS MEDICAL COLLEGE,JAIPUR 
Address  department of anaesthesia,2nd floor, Dhanwantari building, SMS medical college, Jaipur Rajastan 302004 INDIA

Jaipur
RAJASTHAN
302004
India 
Phone  9072751125  
Fax    
Email  ESHANICHU50@GMAIL.COM   
 
Details of Contact Person
Scientific Query
 
Name  Mamta Khandelwal 
Designation  Senior Professor 
Affiliation  SMS medical college, Jaipur 
Address  department of anaesthesia 2nd floor Dhanwantari building SMS medical college Jaipur Jaipur RAJASTHAN 302004 India

Jaipur
RAJASTHAN
302004
India 
Phone  9929338174  
Fax    
Email  drmamtakhandelwal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mamta Khandelwal 
Designation  Senior Professor 
Affiliation  SMS medical college, Jaipur 
Address  department of anaesthesia 2nd floor Dhanwantari building SMS medical college Jaipur Jaipur RAJASTHAN 302004 India

Jaipur
RAJASTHAN
302004
India 
Phone  9929338174  
Fax    
Email  drmamtakhandelwal@gmail.com  
 
Source of Monetary or Material Support  
SMS Medical College 
 
Primary Sponsor  
Name  SMS medical college, Jaipur 
Address  department of anaesthesia 2nd floor dhanwantari building sms medical college jaipur 
Type of Sponsor  Government medical college 
 
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 Mamta Khandelwal  SMS medical college  Department of Anaesthesia, Second Floor, Dhanwantri OPD Block, SMS Medical College Jaipur RAJASTHAN
Jaipur
RAJASTHAN 
9929338174

drmamtakhandelwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
office of ethic comittee sms medical college and attached hospital, jaipur  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 
Comparator Agent  USG guided FASCIA ILIACA COMPARTMENT block in 30 patients  Patients will receive ultrasound guided Pericapsular Nerve Group Block with 20ml of 0.4% Ropivacaine (11.0mL of 0.75% Ropivacaine + 9 mL of Normal Saline). NRS score will be assessed at an interval of 1 minute, up to 20 minutes until NRS less than 3. This time will be noted. In the postoperative period, the analgesic efficacy will be assessed at various intervals for 24 hours.  
Intervention  USG guided PENG block in 30 patients  Patients will receive ultrasound guided pericapsular nerve group block with 20 ml of 0.4% Ropivacaine(11.0mL of 0.75% Ropivacaine + 9mL of Normal Saline). NRS score will be assessed at an interval of 1 minute, up to 20 minutes until NRS less than 3. This time will be noted. In the postoperative period, the analgesic efficacy will be assessed at various intervals for 24 hours.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  64.00 Year(s)
Gender  Both 
Details  1. Patients undergoing elective surgery for hip fracture.

2. Patient having baseline NRS more than 7

3. Patients consenting to participate.

4. Adult patients.

5 Patients belonging to American Society of Anesthesiologists (ASA) grade I,
II and III. 
 
ExclusionCriteria 
Details  1.Patients with psychiatric illness, anxious, agitated.

2.Patients with peripheral sensorineural deficit.

3.Patients allergic to local anesthetics.

4.Patients with contraindications to regional anaesthesia.

5. Patients with suspected compartment syndrome in lower limbs.

6.Patients on analgesia within 8 hours before performing nerve block.

7. Block failure cases -If NRS score is not less than 3 within 20 min of performing
peripheral nerve block. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To assess and compare pain by NRS at
different time intervals after administration of block.

2.To observe the change in NRS at one
minute interval maximum up to 20 minutes
after administration of block, until NRS less
than 3 for positioning of patient for spinal
anaesthesia.

3.To determine the difference in mean time
of first rescue analgesia by using NRS and
mean dose of analgesic required in 24 hours
in both groups.
 
1.To assess and compare pain by
NRS at 30min,1st,2nd,4th and 6th hr followed by every 6th hourly till 24 hours after administering block.

2.To observe the change in NRS at
one minute interval up to 20 minutes
after administration of block, for
positioning of patient for spinal
anaesthesia.

3.To determine the mean dose of
analgesic required in 24 hours in
both groups. 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the change in the hemodynamic parameters (HR, SBP, DBP, MAP and
SpO2) in both groups.
 
at 30 min,1,2,4,6 hour and 6 hourly afterwards till 24 hours after block 
2. To assess and compare patient satisfaction by using three point likert rating scale
between both the groups 
at 30 min,1,2,4,6 hour and 6 hourly afterwards till 24 hours after block 
To observe side effect or complication, if any  in pre-operative,peri-operative and post-operative period 
 
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 2 
Date of First Enrollment (India)   20/05/2025 
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="5"
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 - NO
Brief Summary  

Hip fractures are considered as a widespread problem on a global scale and significant public health issue in numerous nations.  On a worldwide scale, hip fractures are listed as one of the top 10 causes of disability.  Hip fractures frequently occur as urgent orthoedic incidents in the elderly population,and they are linked to notably high rates of morbidity and mortality.In most cases,surgical reduction and fixation represent definitive treatment approach.

Irrespective of the type of surgical procedure, hip surgeries cause significant postoperative pain which can result in further complications and patient dissatisfaction. Indeed, the need for optimal analgesia cannot be underestimated for hip surgeries wherein the patient clientele is mostly elderly and the joint is primarily involved in patient mobility.

The 2011 NICE guidelines for management of hip fractures recommend the use of IV paracetamol, opioids, and peripheral nerve blocks . Oral or intravenous analgesics, particularly opioids can cause unwarranted sedation, nausea, vomiting, respiratory depression, and delirium. The elderly population have a significant risk of delirium due to their age, co-morbidities, altered metabolic functions and physiology, or due to the under or over treatment of pain

Regional anesthetic techniques are increasingly being used to provide better pain control. Peripheral nerve blocks have several advantages such as, adequate pain management in the pre-operative and post-operative time, facilitate early mobilization, and reduction in the dose of opioids required and their related side effects .

The femoral nerve block block and the fascia iliaca compartment block (FICB) are commonly used analgesic techniques in hip surgeries. Both blocks have equivalent analgesic efficacy.

However, a disadvantage of the fascia iliaca block is the associated motor weakness of the surgical limb which can delay recovery and patient discharge 

The hip joint is innervated by branches of the obturator nerve, anterior obturator nerve, and the femoral nerve. Studies suggest that the anterior capsule of the hip joint is richly innervated by these nerves and is targeted to provide analgesia.

 

Recently, GirĂ³n-Arango (9), have described a novel anaesthetic modality named the pericapsular nerve group (PENG) block which anesthetizes the femoral nerve, obturator nerve, and the accessory obturator nerve while sparing the motor components. Studies have shown that the PENG block is efficient in providing postoperative analgesia in patients undergoing hip surgeries with preservation of quadriceps muscle strength

Ultrasound guidance improves visualization of anatomical structures, success rate, quality of sensory block, onset time, decreases dose of local anesthetics and complications.

 

 

There are very few studies that compare the efficacy of PENG vs FIB for postoperative analgesia in patients who underwent surgery for hip fracture.

In this study we aim to compare the preoperative and postoperative analgesic efficacy of ultrasound guided Pericapsular Nerve Group Block vs Fascia iliaca Block In Patients Undergoing Hip Fracture Surgery 

 
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