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CTRI Number  CTRI/2024/02/062805 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 02/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare two drugs dexamethasone and fentanyl as addition to ropivacaine in PENG block for hip joint surgeries to reduce pain 
Scientific Title of Study   “Efficacy and safety of Dexamethasone and Fentanyl as an adjuvant to Ropivacaine in PENG block for proximal femur surgery.”  
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 Vrishali Apte 
Designation  Assistant Professor 
Affiliation  Smt. Kashibai Navale Medical College and General Hospital, Narhe, Pune 
Address  Department of Anaesthesia, SKNMC & GH, Narhe, Pune
Department of Anaesthesia, SKNMC&GH,Narhe, Pune
Pune
MAHARASHTRA
411041
India 
Phone    
Fax    
Email  vya1210@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Vrishali Apte 
Designation  Assistant Professor 
Affiliation  Smt. Kashibai Navale Medical College and General Hospital, Narhe, Pune 
Address  Department of Anaesthesia, SKNMC & GH, Narhe, Pune
Department of Anaesthesia, SKNMC & GH, Narhe, Pune
Pune
MAHARASHTRA
411041
India 
Phone    
Fax    
Email  vya1210@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Vrishali Apte 
Designation  Assistant Professor 
Affiliation  Smt. Kashibai Navale Medical College and General Hospital, Narhe, Pune 
Address  Department of Anaesthesia, SKNMC & GH, Narhe, Pune
Department of Anaesthesia, SKNMC & GH, Narhe, Pune
Pune
MAHARASHTRA
411041
India 
Phone    
Fax    
Email  vya1210@yahoo.co.in  
 
Source of Monetary or Material Support  
SKNMC&GH, Narhe, Pune 
 
Primary Sponsor  
Name  Dr Vrishali Apte 
Address  Department of Anaesthesia, SKNMC & GH, Narhe, Pune 
Type of Sponsor  Other [Self interest] 
 
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 Vrishali Apte  Smt. Kashibai Navale Medical College and General Hospital  Department of Anaesthesia, SKNMC & GH, Narhe, Pune
Pune
MAHARASHTRA 		 9860857338

vya1210@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Smt. Kashibai Navale Medical College and General Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S720||Fracture of head and neck of femur, (2) ICD-10 Condition: S722||Subtrochanteric fracture of femur,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fentanyl   In Group RF (Fentanyl 50mcg + 15ml 0.2% Ropivacaine) will be given to the patient in USG guided PENG (pericapsular nerve group) block perineurally on operative side before start of surgery and patient will be monitored postoperatively till pain score(VAS) becomes more than 3.  
Intervention  Dexamethasone   In Group RD (Dexamethasone 4mg + 15ml 0.2% Ropivacaine) will be given to the patient in USG guided PENG (pericapsular nerve group) block perineurally on operative side before start of surgery and patient will be monitored postoperatively till pain score(VAS) becomes more than 3.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.ASA I &II patients
2.Patients posted for proximal femur surgery under spinal anaesthesia
 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Contraindication to subarachnoid block.
3. Central or peripheral neuropathies
4. Patients with bleeding disorders and those on anticoagulant therapy.
5. History of allergy to local anesthetics.
6. Infection at site of block.
7. Obesity
8. Pregnant women.
9. Patients with psychiatric behavior

 
 
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 
To study postoperative duration of analgesia and requirement of rescue analgesics  VAS will be assessed after shifting the patient to PACU-initially every 30 minutes for 2 hours, then every 2 hours for next 8 hours and then after every 4 hours till 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To study ease for positioning for spinal Anesthesia,Patient’s satisfaction score And adverse effects if any.
 		 Patient will be followed up for 24 hours from the time of PENG block 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   26/02/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  26/02/2024 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study will be conducted at Smt. Kashibai Navale Medical College and general hospital, Pune. After taking written informed consent, patients aged between 18 to 65 years, of either sex will be randomly allocated into two groups. Group RD patients will receive Dexamethasone 4mg as an adjuvant to 15ml 0.2% Ropivacaine in PENG block and Group RF patients will receive Fentanyl 50mcg as an adjuvant to 15ml of 0.2% Ropivacaine in PENG block. 
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