FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/06/053932 [Registered on: 15/06/2023] Trial Registered Prospectively
Last Modified On: 14/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of pericapsular nerve group block and femoral nerve block for analgesia after hip fracture surgery 
Scientific Title of Study   Randomized Comparative Study of Ultrasound Guided Pericapsular Nerve Group Block vs Femoral Nerve Block for postoperative analgesia in hip fracture surgery in Department of Anaesthesia, SMS Medical College, Jaipur. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mamta Khandelwal  
Designation  Senior Professor 
Affiliation  SMS Medical College 
Address  Department of Anaestehsia, SMS Medical College, Jaipur.

Jaipur
RAJASTHAN
302004
India 
Phone  9929338174  
Fax    
Email  drmamtakhandelwal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mamta Khandelwal  
Designation  Senior Professor 
Affiliation  SMS Medical College 
Address  Department of Anaestehsia, SMS Medical College, Jaipur.


RAJASTHAN
302004
India 
Phone  9929338174  
Fax    
Email  drmamtakhandelwal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Darshan N 
Designation  Junior Resident 
Affiliation  SMS MEDICAL COLLEGE 
Address  Department of Anaestehsia, SMS Medical College, Jaipur.

Jaipur
RAJASTHAN
302004
India 
Phone  9611831038  
Fax    
Email  drdarshan817@gmail.com  
 
Source of Monetary or Material Support  
SMS Medical College 
 
Primary Sponsor  
Name  Sawai Man Singh Medical College 
Address  Department of Anaestehsia, Second Floor, Dhanwantri OPD Block, 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 
9929338174

drmamtakhandelwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of the Ethics Committee, SMS Medical College and Attached Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  USG guided FNB in 40 patients  Patients will receive ultrasound guided Femoral nerve block with 20 ml of 0.5% Ropivacaine(13.3mL of 0.75% Ropivacaine + 6.7mL 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 40 patients  Patients will receive ultrasound guided Pericapsular Nerve Group Block with 20ml of 0.5% Ropivacaine (13.3mL of 0.75% Ropivacaine + 6.7mL 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  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients undergoing elective surgery for hip fracture, with NRS >7.
Patients consenting to participate.
Adult patients aged 30-70 Years.
Patients belonging to American Society of Anesthesiologists (ASA) grade I, II and III.
 
 
ExclusionCriteria 
Details  Patients with psychiatric illness, anxious, agitated.
Patients with peripheral sensorineural deficit.
Patients allergic to local anesthetics.
Patients with contraindications to regional anaesthesia.
o Patients with suspected compartment syndrome in lower limbs.
Patients on analgesia within 8 hours before performing nerve block.
Block failure cases (If NRS score is not < 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 in the postoperative period in both the groups.
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 hourly intervals till 6hrs and two hourly intervals till 24 hrs postoperatively.
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 
1.To asses quadriceps muscle strength using Oxford muscle strength grading.
2. To determine the change in the haemodynamic parameters (HR, SBP, DBP, MAP & SpO2) in both groups.
3. To assess patient satisfaction.
4. To observe side effect or complication, if any.
 
1.To asses quadriceps muscle strength using Oxford muscle strength grading at hourly intervals till 6hrs & two hourly intervals till 24 hrs postoperatively.
2.To determine the change in the haemodynamic parameters (HR, SBP, DBP, MAP & SpO2) in both groups at hourly intervals till 6hrs & at two hourly intervals till 24 hrs .
3.To assess patient satisfaction after 24hrs postoperatively.
4.To observe side effect or complication, if any.
 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 1/ Phase 2 
Date of First Enrollment (India)   25/06/2023 
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="0"
Months="10"
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 - NO
Brief Summary  

Hip fractures are regarded as a worldwide epidemic and a major public health concern inmany countries (1). Globally, hip fractures rank among the top 10 causes of disability (2). Hipfractures are a common orthopaedic emergency in the elderly, and is associated with significant mortality and morbidity. Surgical reduction and fixation are the definitive treatment in most patients (3).

The majority of hip fractures in the elderly population results from an inadvertent fall,whereas, it is more commonly caused due to a high energy trauma in the younger and adultpopulation

(4). Irrespective of the aetiology, hip fractures are a painful condition, and early pain relief and definitive management is of utmost importance, especially in the elderly population.

Pre-operative pain from hip fractures can be managed by several modalities. The 2011 NICE guidelines for management of hip fractures recommend the use of IV paracetamol, opioids,and peripheral nerve blocks (5). 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, alteredmetabolic functions and physiology, or due to the under or over treatment of pain (6, 7).

Peripheral nerve blocks have several advantages such as, adequate pain management in thepre- operative and post-operative time, facilitate early mobilization, and reduction in the dose of opioids required and their related side effects (3, 8).

The hip joint is innervated by branches of the obturator nerve, anterior obturator nerve, andthe femoral nerve. Studies suggest that the anterior capsule of the hip joint is richlyinnervated by these nerves and is targeted to provide analgesia. Regional anaesthetic techniques such as Femoral Nerve Block (FNB), and Fascia Iliaca Block (FIB) are routinely used for effective peri-operative analgesia due to opioid sparing effects. But, these blockades only provide moderate analgesia as the obturator nerve is inadequately affected (3, 9).

 

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

The Femoral Nerve Block targets the lateral femoral cutaneous nerve, femoral nerve, and the obturator nerve (9). The Pericapsular Nerve Group Block targets the articular branches of obturator nerve, anterior obturator nerve, and the femoral nerve, and is found to be aneffective regional anaesthetic technique for hip fracture surgeries (10).

After thorough review, there are very few studies that compare the efficacy of ultrasound guided PENG vs FNB for postoperative analgesia in patients who underwent surgery for hip fracture using 20mL of 0.5% Ropivacaine.

 
Close