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CTRI Number  CTRI/2023/04/052079 [Registered on: 27/04/2023] Trial Registered Prospectively
Last Modified On: 27/04/2023
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 compare the efficacy of Pericapsular Nerve Group (PENG) Block versus Supra-Inguinal Fascia Iliaca (SIFI) Block for post-operative pain relief in hip surgeries. 
Scientific Title of Study   Comparison of Pericapsular Nerve Group (PENG) Block versus Supra-Inguinal Fascia Iliaca (SIFI) Block for post-operative analgesia in Hip surgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M Rupinder Singh 
Designation  Professor Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia Dayanand Medical College and Hospital
Civil Lines Tagore Nagar
Ludhiana
PUNJAB
141001
India 
Phone  9814046459  
Fax    
Email  drmrupindersinghdmch@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tanusha Saini 
Designation  PG Resident Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia Dayanand Medical College and Hospital
Civil Lines Tagore Nagar
Ludhiana
PUNJAB
141001
India 
Phone  6239510393  
Fax    
Email  tanushasaini01@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tanusha Saini 
Designation  PG Resident Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia Dayanand Medical College and Hospital
Civil Lines Tagore Nagar
Ludhiana
PUNJAB
141001
India 
Phone  6239510393  
Fax    
Email  tanushasaini01@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Medical College and Hospital, Ludhiana. 
 
Primary Sponsor  
Name  Dayanand Medical College and Hospital 
Address  Civil Lines, Tagore Nagar, Ludhiana, Punjab, India. 141001 
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 M Rupinder Singh  Dayanand Medical College and Hospital  Department of Anaesthesia, Dayanand Medical College and Hospital, Civil Lines, Tagore Nagar, Ludhiana 141001.
Ludhiana
PUNJAB 
9814046459

drmrupindersinghdmch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethics Committee, Dayanand Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pericapsular Nerve Group (PENG) Block for postoperative analgesia in Hip surgeries  Patients in group A will receive an ultrasound-guided Pericapsular Nerve Group (PENG) Block with 30ml of 0.2% Ropivacaine and 4mg and dexamethasone. Post-operative pain will be measured using VAS pain scores at 24 hours at rest. 
Comparator Agent  Supra Inguinal Fascia iliaca (SIFI) Block for postoperative analgesia in Hip surgeries  Patients in group B will receive an ultrasound-guided Supra Inguinal Fascia Iliaca (SIFI) Block with 30ml of 0.2% Ropivacaine and 4mg dexamethasone. Post-operative pain will be measured using VAS pain scores at 24 hours at rest. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Patients aged 40-85 years of age
2. ASA Physical status I, II, III
3. Electively scheduled for hip surgeries.
4. Body mass index between 18-35 kg/m2
 
 
ExclusionCriteria 
Details  1. Known allergy to study drugs
2. Contraindication to neuraxial blockade or
peripheral nerve blocks
3. Chronic opioid use
4. Diabetic neuropathy
5. Infection at the site of block
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
For PRIMARY OUTCOME: Postoperative pain will be measured using VAS pain scores at 24 hours at rest in both the groups.  The patients will be monitored hourly for the first 4 hours, 2 hourly for the next 4 hours and then every 4 hourly till 24 hours post-operatively. 
 
Secondary Outcome  
Outcome  TimePoints 
For SECONDARY OUTCOMES:
• functional mobility will be
assessed by assessing
quadriceps muscle strength
by Manual Muscle Testing
scale and maximum weight-
bearing possible at 24 hours
and 48 hours post-
operatively.
• time for first rescue
analgesia.
• total opioid consumption in
first 24 hours.
• overall patient satisfaction
for pain management within
24 hours in both the groups.
• surgeon’s satisfaction to
anaesthesia services for
overall pain management post
operatively.

 
Functional mobility and weight bearing will be measured at 24 and 48 hours. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/05/2023 
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="1"
Months="6"
Days="29" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not Yet Published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Hip procedures are common orthopedic surgeries performed routinely and are associated with significant amount of pain. Adequate analgesia is very crucial post-operatively to enhance dynamic pain relief, early patient recovery, reduced hospital stay, prevention of readmissions along with overall improved patient satisfaction to recovery. Peripheral nerve blocks have the advantage of potent analgesia, minimal systemic complications which are associated with central neuraxial blockades and less motor blockade, therefore leading to early patient recovery and overall better outcomes. A prospective, double-blinded randomized study will be conducted on 60 adult patients, ASA- I to III undergoing orthopedic surgeries for hip fractures, under sub-arachnoid block in which they will be randomly allocated to either group A which will receive 30ml of 0.2% Ropivacaine with 4mg dexamethasone USG-guided pericapsular nerve group (PENG) block or to group B which will receive 30ml of 0.2% Ropivacaine with 4mg dexamethasone USG-guided supra-inguinal fascia iliaca (SIFI) block. The primary outcome is comparing VAS scores at rest at 24 hours in both the groups. The secondary outcome is functional mobility at 24 and 48 hours postoperatively by assessing the quadriceps muscle strengthmaximum weight bearing possible at 24 hours and 48 hours post-operatively, time to need for first rescue analgesia, total opioid consumption in first 24 hours along with overall patient satisfaction to recovery and surgeon’s satisfaction to overall pain management in both the groups.


 
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