FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/02/040557 [Registered on: 23/02/2022] Trial Registered Prospectively
Last Modified On: 06/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Pain relief in hip fracture patients using latest ultrasound technology. 
Scientific Title of Study   Comparison of analgesic efficacy between Fascia iliaca compartment block (FICB), Femoral nerve block (FNB) and PEricapsular Nerve Group block (PENG) in patients with Hip Fractures: A randomized double blind trial. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajendra kumar Sahoo 
Designation  Senior consultant, Pain and Palliative Care 
Affiliation  Kalinga Institute Of Medical Sciences 
Address  Kalinga Institute Of Medical Sciences,Kushabhadra Campus(KIIT Campus)Patia Bhubaneswar Khurda, Odisha
Kushabhadra Campus(KIIT Campus)Patia Bhubaneswar Khurda, Odisha 751024
Khordha
ORISSA
751024
India 
Phone  7750008259  
Fax    
Email  rajendra.sahoo@kims.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajendra kumar Sahoo 
Designation  Senior consultant, Pain and Palliative Care 
Affiliation  Kalinga Institute Of Medical Sciences 
Address  Kalinga Institute Of Medical Sciences,Kushabhadra Campus(KIIT Campus)Patia Bhubaneswar Khurda, Odisha
Kushabhadra Campus(KIIT Campus)Patia Bhubaneswar Khurda, Odisha 751024
Khordha
ORISSA
751024
India 
Phone  7750008259  
Fax    
Email  rajendra.sahoo@kims.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Rajendra kumar Sahoo 
Designation  Senior consultant, Pain and Palliative Care 
Affiliation  Kalinga Institute Of Medical Sciences 
Address  Kalinga Institute Of Medical Sciences,Kushabhadra Campus(KIIT Campus)Patia Bhubaneswar Khurda, Odisha
Kushabhadra Campus(KIIT Campus)Patia Bhubaneswar Khurda, Odisha 751024
Khordha
ORISSA
751024
India 
Phone  7750008259  
Fax    
Email  rajendra.sahoo@kims.ac.in  
 
Source of Monetary or Material Support  
kalinga institute of medical sciences 
 
Primary Sponsor  
Name  Dr Rajendra Kumar Sahoo 
Address  Kalinga Institute of medical sciences, kushabhadra campus -5, KIIT, patia, Bhubaneswar,odisha, 751024 
Type of Sponsor  Private 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 Rajendra Kumar Sahoo  Kalinga Institute of Medical Sciences  3rd floor OT COMPLEX, Kushabhadra Campus(KIIT Campus)Patia Bhubaneswar Khurda, Odisha 751024
Khordha
ORISSA 		 7750008259
916742725415
rajendra.sahoo@kims.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE , KALINGA INSTITUTE OF MEDICL SCIENCES(KIMS), KIIT DEEMED TO BE UNIVERSITY, BHUBA NESWAR-751024  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M848||Other disorders of continuity of bone, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  not applicable 
Intervention  Ultrasound guided femoral nerve block  Group II: FNB- ultrasound- guided femoral nerve block with 25ml 0.25% Ropivacaine+ 5 ml 0.25% Ropivacaine for lateral femoral cutaneous nerve block (LFCN)+ 4mg (1ml) dexamethasone once in the preoperative area and wait for 30 minute to record pain score followed by spinal anesthesia.  
Intervention  Ultrasound guided Pericapsular nerve group block  Group III: PENG-ultrasound-guided pericapsular nerve group block with 25 ml 0.25% Ropivacaine+ 5 ml 0.25% Ropivacaine for lateral femoral cutaneous nerve block (LFCN)+ 4mg (1ml) dexamethasone once in the preoperative area and wait for 30min to look for reduction in pain score followed by spinal anesthesia. 
Intervention  ultrasound- guided supra-inguinal fascia iliaca block   Group I: S-FICB- ultrasound- guided supra-inguinal fascia iliaca block with 40ml of 0.25% Ropivacaine + 4mg (1ml) dexamethasone once in the preoperative area and wait for 30 minute to record pain score followed by spinal anesthesia.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients aged 40 years and above of American Society of Anesthesiologists physical status (ASA) I-III with hip fracture scheduled for surgery under spinal anesthesia.  
 
ExclusionCriteria 
Details  1.Patient refusal to participate
2.Contraindication to Spinal anesthesia or peripheral nerve blocks
3.Patients with significant cognitive impairment
4.Patients on opioids for chronic pain
 
 
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 
-Visual analogue score (VAS) at rest and on passive 15° limb lifting, 30 min after the block.
- Ease of spinal positioning (EOSP).
 		 -Visual analogue score (VAS) at rest and on passive 15° limb lifting, 30 min after the block and it will be noted once and then patient will be taken inside operation theatre for spinal anesthesia.
- Ease of spinal positioning (EOSP) score while positioning for spinal anesthesia will be noted once.
 
 
Secondary Outcome  
Outcome  TimePoints 
-Visual analogue score (VAS) at rest and on passive 15° limb lifting at 3, 6,
12 and 24 hours postoperatively.
-Time to first rescue analgesic (tramadol) request.
-Total opioid consumption (in mg) in first 24 hours.
-Patient´s satisfaction.
-Quadriceps strength at 6, 12 and 24 hours.
 		 up to 24 hours in the post operative period. 
 
Target Sample Size   Total Sample Size="175"
Sample Size from India="175" 
Final Enrollment numbers achieved (Total)= "180"
Final Enrollment numbers achieved (India)="180" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/02/2022 
Date of Study Completion (India) 01/06/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
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   Hip fracture is a common orthopedic emergency in elderly people which can result in significant morbidity and mortality. Spinal anesthesia is the  most commonly used anesthetic technique to fix these fractures.Hip surgery leads to moderate to severe pain which, if poorly controlled is associated with longer hospital length of stay, delayed ambulation and increased risk of delirium. Regional analgesia techniques, including Femoral nerve block(FNB) and Fascia iliaca compartment block(FICB) have become increasingly popular and commonly used for better perioperative pain control and opioid sparing effects. But both of these blocks lead to lower limb weakness.
     In recent times, the Pericapsular nerve group block (PENG) has emerged superior to both FNB and FICB due to complete anesthesia of the joint capsule with motor sparing effects. To date, the analgesic efficacy of ultrasound guided FICB has not been directly compared with those of ultrasound guided FNB or PENG block. So this prospective randomised study is designed to compare immediate pain relief at 30min after the block and pain relief while positioning patients for spinal anesthesia before femoral neck fracture repair between PENG, FNB and FICB.
 
Close