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CTRI Number  CTRI/2024/03/064491 [Registered on: 20/03/2024] Trial Registered Prospectively
Last Modified On: 19/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effects of two nerve blocks, pericapsular nerve group block with lateral femoral cutaneous nerve block as an adjunct to spinal anaesthesia and comparing it with effect of Combined spinal epidural anaesthesia in patients undergoing total hip replacement. 
Scientific Title of Study   A COMPARATIVE EVALUATION BETWEEN A COMBINATION OF PERICAPSULAR NERVE GROUP (PENG) BLOCK AND LATERAL FEMORAL CUTANEOUS NERVE (LFCN) BLOCK AS AN ADJUNCT TO SPINAL ANAESTHESIA VERSUS COMBINED SPINAL EPIDURAL ANAESTHESIA FOR POSTOPERATIVE ANALGESIA AND FUNCTIONAL RECOVERY FOLLOWING TOTAL HIP ARTHROPLASTY: A RANDOMISED CONTROLLED 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  Sudarshan Kumar Garg 
Designation  Junior Resident 
Affiliation  Army Hospital Research and Referrall, New Delhi 
Address  Department of Anaesthesiology, Army Hospital Research and Referral, New Delhi, Delhi Cantt

New Delhi
DELHI
110010
India 
Phone  9915421282  
Fax    
Email  sudarshan.garg@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajeev Nair 
Designation  Professor  
Affiliation  Army Hospital Research and Referral, New Delhi 
Address  Head of Department, Department of Anaesthesiology, Army Hospital Research and Referral, New Delhi, Delhi Cantt

New Delhi
DELHI
110010
India 
Phone  7757024594  
Fax    
Email  rjv.nr1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sudarshan Kumar Garg 
Designation  Junior Resident 
Affiliation  Army Hospital Research and Referral, New Delhi 
Address  Department of Anaesthesiology, Army Hospital Research and Referral, New Delhi, Delhi Cantt

New Delhi
DELHI
110010
India 
Phone  9915421282  
Fax    
Email  sudarshan.garg@gmail.com  
 
Source of Monetary or Material Support  
Army Hospital Research and Referral, Delhi Cantt 
 
Primary Sponsor  
Name  Dr Rajeev Nair 
Address  Army Hospital Research and Referral, New Delhi 110010 
Type of Sponsor  Other [self] 
 
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 Sudarshan Garg  Army Hospital Research and Referral   Department of Anaesthesiology
New Delhi
DELHI 
9915421282

sudarshan.garg@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Army Hospital R&R, Delhi Cantt  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  Combined Spinal Epidural Anaesthesia  Patient will receive two injections in the spine which will be given after locally anaesthetising the area. A catheter will be placed through one of the injection which will be connected to a continuous drug infusion pump to control postoperative pain. Injection will be given reparative just before surgery and monitoring will be done for 48 hours. 
Intervention  Pericapsular Nerve Group Block with Lateral Femoral Cutaneous Nerve along with Spinal Anaesthesia  Patient will receive Spinal Anaesthesia in which an injection will be given in the spine of the patient and lower part of the body will be anaesthetised. After achieving complete anaesthesia of the lower limbs, two injections will be given in the thigh through which drugs will be given to control the postoperative pain. Injections will be given preoperatively just before surgery and monitoring will be done for 48 hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. ASA Physical status I- III
2. Patient consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Refusal to participate in the study.
2. Patients having coagulopathy.
3. Patients allergic to local anesthetic (LA)
4. Patients having sepsis.
5. Patients with hepatic or renal failure,
6. Pregnant patients  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Postoperative Pain Scores
Postoperative Motor strength 
0,6,12,24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Use of Rescue Analgesia
Time to 1st walk 
12, 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 4 
Date of First Enrollment (India)   30/03/2024 
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="1"
Months="8"
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  

Eligible patients will be randomly allocated into two groups to receive either Pericapsular Nerve Group (PENG) block with Lateral Femoral Cutaneous Nerve (LFCN) block as an adjunct to Spinal Anaesthesia (Group - A) or Combined Spinal Epidural Anaesthesia (Group B). Randomization will be achieved using computer-generated lists and treatment allocation concealed using consecutively numbered, sealed, opaque envelopes. Every patient will be informed of the sequence of procedures during anaesthesia and surgery, and signed informed consent in their vernacular language will be obtained before enrolment. 

Group A will receive Spinal Anaesthesia under all aseptic precautions using Quincke spinal needle 25G/26G in L2-L3 / L3-L4 space. Inj Bupivacaine H 0.5% 2.5ml with Inj Fentanyl 25mcg 0.5ml will be administered in the subarchnoid spaceAfter receiving spinal anaesthesia patients will be givenultrasound guided Pericapsular Nerve Group (PENG) block and Lateral Femoral Cutaneous nerve block preoperatively using stimuplex needleand Inj Bupivacaine 0.25% plain 20ml will be given for PENG block and 5ml for Lateral Cuteness Femoral Nerve Block.  

Group B will receive Combined Spinal Epidural Anaesthesia under all aseptic conditions. Spinal Anaesthesia using Quincke spinal needle 25G/26G in L2-L3 / L3-L4 space and Inj Bupivacaine H 0.5% 2.5ml with Inj Fentanyl 25mcg 0.5ml will be given. Epidural Anaesthesia will be given using 18G Touhy’s needle and catheter will be left in situ. Postoperative controlled drug administration of InjBupivacaine 0.125% through epidural catheter will be done and infusion will be started at 5ml/hr initially which will be titrated in the next 1-2 days according to the pain. In both the groups, rescue analgesia of Inj Tramadol 100mg iv will be administered as requirement basis

At all postoperative time points (0, 6, 12, 24 hr) patients will be asked to indicate perceived pain using a 0-10 VAS score (0- No pain, 10- Worst pain). Motor recovery of the hip joint will be assessed at 24 h using range of motion, where active hip flexion (between 0° and 90°) will be measured using a goniometer. In addition, ‘time to first walk’, defined as the time between the end of surgery and the ability to take at least three steps with the help of the walker, will be recorded after the first 12 postoperative hours, and re-evaluated on the first postoperative day. Outcome assessment will be performed by a different clinician who will be blinded to the group allocation. 

 
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