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CTRI Number  CTRI/2024/06/068666 [Registered on: 11/06/2024] Trial Registered Prospectively
Last Modified On: 10/06/2024
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Suprainguinal fascia iliaca block versus anterior quadratus lumborum block comparison in perioperative patients in hip surgeries. 
Scientific Title of Study   A comparison of ultrasound guided suprainguinal fascia iliaca(SIFI) block versus anterior quadratus lumborum block(via suprailiac approach) for perioperative analgesia in patients posted for surgeries involving hip joint. 
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. Priyanka Bansal 
Designation  Associate Professor  
Affiliation  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science. 
Address  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science, Department of Anaesthesiology and Critical Care, Second floor, Room no: 16, Rohtak.

Rohtak
HARYANA
124001
India 
Phone  8683921867  
Fax    
Email  dr.priyankabansal1986@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Nidvanche Swapnil 
Designation  Post Graduate 
Affiliation  Pandit Bhagwat Dayal Sharma Institute of Medical Science. 
Address  Pandit Bhagwat Dayal Sharma Institute of Medical Science, Department of Anesthesiology and Critical Care, Doctors PG Hostel, Room No:06,Rohtak.

Rohtak
HARYANA
124001
India 
Phone  6303535394  
Fax    
Email  Swapnilnidvanche123@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Priyanka Bansal 
Designation  Associate Professor 
Affiliation  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science. 
Address  Pandit Bhagwat Dayal Institute of Medical Science, Department of Anaesthesiology and Critical Care, Second floor, Room no: 16, Rohtak.

Rohtak
HARYANA
124001
India 
Phone  8683921867  
Fax    
Email  dr.priyankabansal1986@gmail.com  
 
Source of Monetary or Material Support  
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science, Rohtak, Haryana-124001, India. 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Nidvanche Swapnil   Pandit Bhagwat Dayal Post Graduate Institute of Medical Science.  Department of Anaesthesiology and Critical Care,Second floor, Seminar Room no:32
Rohtak
HARYANA 		 6303535394

Swapnilnidvanche123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bio Medical Research Ethics Comittee, Pt. B.D. Sharma PGIMS/UHS, Rohtak.  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  ANTERIOR QUADRATUS LUMBORUM BLOCK  USG GUIDED ANTERIOR QL BLOCK VIA SUPRA INGUINAL APPROACH USING 0.25% ROPIVACAINE. Probe first will be placed in a parasagittal orientation 3–4 cm lateral to the midline and over the sacrum to identify the tip of the L5 transverse process. The probe will then rotated into a transverse orientation with slight medial and caudal angulation to obtain a transverse oblique view at L5 transverse process. The ultrasound probe will further tilted so the lateral end of the ultrasound probe will be more cranial than the medial side of the probe to avoid the acoustic shadow of the iliac crest. This served to direct the angle of the probe, and thus the sonographic beam, caudally into the pelvis. It will allow the latissimus dorsi aponeurosis (laterally), QL muscle, psoas major muscles, and L5 transverse process (medially) to be visualized. An 8 cm, 17 G echogenic Tuohy needle will advanced in plane in a lateral-to-medial direction, through the latissmus dorsi aponeurosis and QL muscle to position the tip between the QL and psoas major muscles close to the transverse process. Correct needle tip position will be confirmed by injecting 2–3 mL of sodium chloride 0.9%. Spread will be deemed appropriate when injectate will be seen between QL and psoas major muscles and tracking medially towards the L5 transverse process. In the all patients,30 mL of 0.25% Ropivacaine will be given. 
Intervention  SUPRAINGUINAL FASCIA ILIACA BLOCK  USG GUIDED SIFI BLOCK USING 0.25% ROPIVACAINE. In Fascia iliaca block the transducer will be placed transversely on the inguinal crease, followed by slow movement laterally or medially. Tilting the probe while pressing helps to identify the hyperechoic fascia iliaca superficial to the hypoechoic iliopsoas muscle. Medially, the femoral nerve will be visualized deep to the fascia and lateral to the artery. Laterally, the muscle is seen by its typical triangular shape when compressed by the transducer. After a skin wheal is made, the needle will be inserted in-plane. As the needle passes through fascia iliaca, the fascia is first seen indented by the needle. After negative aspiration, 30 mL of local anaesthetic (Ropivacaine 0.25%) will be injected between the fascia and the iliopsoas muscle. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1: Patients belonging to ASA Physical status I-III.
2: Patients scheduled for surgeries involving hip joint. 
 
ExclusionCriteria 
Details  1: Patients having bleeding tendency
2: Patients on Anticoagulants
3: Patients with peripheral neuropathy
4: Patients allergic to amide local anesthetics
5: Patients with mental disorder
6: Patients with local infection at injection site.
7: Patient who refuse to participate. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Total Analgesic Requirement after surgery, calculated by Oral Morphine Milligram Equivalent.   First 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
NRS SCORE  2,4,6,8,12,24 HOURS 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   24/06/2024 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.priyankabansal1986@gmail.com].

  6. For how long will this data be available start date provided 02-01-2026 and end date provided 01-01-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   We intend to undertake the study to compare ultrasound guided suprainguinal fascia iliaca block versus anterior qudratus lumborum block for perioperative analgesia in patients posted for surgeries involving hip joint. The Primary objective of study is to calculate the total analgesic requirement in the first 24 hours calculated in terms of OMME. The total of 40 patients between the age of 18 to 75 years of eithers sex belonging to ASA physical status I-III scheduled for surgeries involving hip joint will be included. The patients will be randomized into two groups using computer generated random numbers. 
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