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CTRI Number  CTRI/2021/08/036083 [Registered on: 31/08/2021] Trial Registered Prospectively
Last Modified On: 22/08/2021
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   Which block has better efficacy USG guided Pericapular Nerve Group Block versus Lumbar Plexus Block for postoperative analgesia in patients undergoing hip surgery 
Scientific Title of Study   A randomised controlled trial to assess the efficacy of Pericapsuler Nerve Group Block verses Lumbar Plexus Block for postoperative analgesia in patients undergoing hip surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SUNIL KUMAR SINHA 
Designation  Professor 
Affiliation  Lady Hardinge Medical College 
Address  Department of anaesthesiology, Lady Hardinge Medical College
Department of anaesthesiology, Lady Hardinge Medical College
Central
DELHI
110001
India 
Phone  9868493597  
Fax    
Email  sunilsinha248@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  SUNIL KUMAR SINHA 
Designation  Professor 
Affiliation  Lady Hardinge Medical College 
Address  Department of anaesthesiology, Lady Hardinge Medical College

Central
DELHI
110001
India 
Phone  9868493597  
Fax    
Email  sunilsinha248@gmail.com  
 
Details of Contact Person
Public Query
 
Name  ARSHAN ALI 
Designation  Post Graduate Student 
Affiliation  Lady Hardinge Medical College, 
Address  Department of anaesthesiology, Lady Hardinge Medical College
Department of anaesthesiology, Lady Hardinge Medical College
Central
DELHI
110002
India 
Phone  8700898608  
Fax    
Email  arshan47ali@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesiology, Lady Hardinge Medical College, Central Delhi 
 
Primary Sponsor  
Name  Lady Hardinge Medical College 
Address  Shaheed Bhagat Singh Marg, Central Delhi 
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 ARSHAN ALI  Lady Hardinge Medical College  Department of anaesthesiology, Lady Hardinge Medical College, Shaheed Bhagat Singh; Marg,Central Delhi
Central
DELHI 
8700898608

arshan47ali@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee for human research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lumbar Plexus Block  Nerve stimulator used along with USG guidance by using needle 22G needle 
Comparator Agent  Pericapsular Nerve Group Block  By using low frequency USG guided needle 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Adult patients ASA I and ASA II 18-70 years posted for hip surgery 
 
ExclusionCriteria 
Details  1.Any known drug allergies.
2.Contraindication to nerve block like coagulopathy, bleeding diathesis and local infection
3.Patient requires general anaesthesia during surgery
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean opioid consumption (in mg/kg) at the end of 24 hours postoperatively in both PENG block and lumbar plexus block group  Mean opioid consumption (in mg/kg) at the end of 24 hours postoperatively in both PENG block and lumbar plexus block group 
 
Secondary Outcome  
Outcome  TimePoints 
1.Mean NRS on rest at 0, 4, 8, 12&24 hr postoperatively in both the group

2.Mean NRS on limb movement at 0, 4, 8, 12&24 hr postoperatively in both the group

3.Proportion of patient developing Nausea, vomiting, numbness, sedation and motor weakness

 
24hour 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   07/09/2021 
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="2"
Days="2" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Results will be published in a scientific journal 
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, & associated with significant morbidity and mortality. Surgical reduction and fixation is the definitive treatment in most patients to improve mobility and quality of life. Adequate pain relief is essential in the postoperative period to enable ambulation and initiation of physiotherapy.
Various methods have been used to provide post op analgesia. Intravenous patient-controlled analgesia (IV PCA) or epidural analgesia are the most common methods. IV PCA is associated with poor pain control and opioid associated complications. Epidural analgesia may lead to hemodynamic instability and bilateral motor block.
Recently, peripheral nerve blockade has emerged alternative analgesic approach.4 Femoral nerve block and fascia illiaca block are useful however they are associated with inadequate pain control for hip surgery because of low propensity to block obturator nerve.
 Lumbar plexus block or psoas compartment blocks has been considered Gold standard, as it reliably block all its branches including obturator nerve and provide potent analgesia with reduce opioid consumption for hip surgery. It is a deep block and technically challenging even with the use of ultrasound.
 Recently ultrasound guided Pericapsular Nerve Group (PENG) block has been described which block articular branches of hip supplied by femoral, obturator, and accessory obturator nerve. Technique for PENG block is easy as it is quite superficial as well as initial data on its application and hip surgery is in encouraging.
 
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