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CTRI Number  CTRI/2024/06/068790 [Registered on: 12/06/2024] Trial Registered Prospectively
Last Modified On: 12/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   The advantage of combining two nerve blocks to decrease the post operative pain in hip fracture surgeries. 
Scientific Title of Study   Analgesic efficacy of combining pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve block (LFCN) in fractured hip surgeries under spinal anaesthesia - a randomised 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  Ujjaini Ray 
Designation  post graduate student 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology Kalinga institute of medical sciences, KIIT university Patia, Bhubaneshwar.

Khordha
ORISSA
751024
India 
Phone  9958538812  
Fax    
Email  2387013@kims.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Laxman Kumar Senapati 
Designation  Associate Professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology , Kalinga institute of medical sciences , KIIT University Patia Bhubaneshwar

Khordha
ORISSA
751024
India 
Phone  9958538812  
Fax    
Email  meet.laxmans1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ujjaini Ray 
Designation  post graduate student 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology Kalinga institute of medical sciences, KIIT university Patia, Bhubaneshwar.

Khordha
ORISSA
751024
India 
Phone  9958538812  
Fax    
Email  2387013@kims.ac.in  
 
Source of Monetary or Material Support  
Institutional- Kalinga Institute Of Medical Sciences 
 
Primary Sponsor  
Name  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology , Kalinga Institute of Medical Sciences , KIIT University, 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 Ujjaini Ray  Pradyuman Bal Memorial Hospital, Kalinga Institute Of Medical Sciences   Department of Anaestgesiology, Kushabhadra Campus (KIIT Campus-5) Patia, Bhubaneswar Odisha, India – 751024
Khordha
ORISSA 		 9958538812

2387013@kims.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kalinga Institute of Medical Sciences  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 
Intervention  Ultrasound guided Pericapsular Nerve Group Block  USG guided Pericapsular Nerve Group Block with 25 ml of 0.25% of Ropivacaine + 4 mg dexamethasone Duration of procedure: 15 minutes 
Comparator Agent  Ultrasound guided pericapsular nerve group block with lateral femoral cutaneous nerve block  USG guided combined Pericapsular nerve group block and Lateral Femoral Cutaneous Nerve Block with 20ml of 0.25% Ropivacaine + 0.25% Ropivacaine 5ml for LFCN block + 4mg dexamethasone. Duration of procedure: 20 minutes  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All willing and consenting participants,
American Society of Anaesthesiologist (ASA) physical status I-III 
 
ExclusionCriteria 
Details  Participants with coagulopathy , cardiovascular disease , psychiatric illness, speech and hearing impairment, morbidly obese and those allergic to anaesthetic drugs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The time required to request for the 1st rescue analgesia with tramadol in minutes.  at 0 minutes , 30 minutes , 60 minutes, 90 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
The Numerical Rating Scale (NRS) for Pain recorded post block at rest and upon movement i.e. by passively lifting the limb 15° above the resting level.  30 minutes 
Ease of spinal Positioning score assessed using a four-point scale.   30 MINUTES 
Total tramadol consumption.  24 HOURS 
Any complications or adverse effect would be measured.  24 HOURS 
Patient satisfaction score.  24 hours 
 
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 2 
Date of First Enrollment (India)   01/07/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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   Orthopaedic surgeries, especially those around the hip joint are extremely painful for the patient as it involves extensive soft tissue, muscles, ligaments and bone dissection. 
The Pericapsular nerve group block is an ultrasound-guided approach for the blockade of the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule. 
Most hip surgeries require a lateral incision, which involves the cutaneous supply by the branches of the Lateral Femoral Cutaneous Nerve (LFCN).
Hence, we will conduct a double blinded, randomized study to compare PENG block with a combination of PENG block and LFCN block for efficacy of analgesia in fractured hip surgery.
 
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