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CTRI Number  CTRI/2022/07/043834 [Registered on: 07/07/2022] Trial Registered Prospectively
Last Modified On: 06/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Two different block for pain relief after hip surgeries 
Scientific Title of Study   To evaluate the effect of ultrasound guided Fascia iliaca compartment block (FIC) and Pericapsular Nerve Group (PENG) block on the postoperative analgesia in patients undergoing 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 Geeta Singariya 
Designation  Senior Professor 
Affiliation  Dr S N Medical Collage Jodhpur 
Address  Dr S N medical collage Jodhpur
123 Vaishali Avenue Jhawar road JODHPUR
Jodhpur
RAJASTHAN
342001
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manish Garg 
Designation  Junior Resident 
Affiliation  Dr S N medical Collage Jodhpur 
Address  Dr S N Medical Collage Jodhpur
Main OT Complex, First floor, M D M Hospital, Shastri Nagar, Jodhpur (Rajasthan)
Jodhpur
RAJASTHAN
342001
India 
Phone  8930877119  
Fax    
Email  mkgarg93@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Geeta Singariya 
Designation  Senior Professor 
Affiliation  Dr .S N Medical collage Jodhpur 
Address  Dr S N medical Collage Jodhpur
Main OT Complex, First floor, M D M Hospital, Shastri Nagar, Jodhpur (Rajasthan)
Jodhpur
RAJASTHAN
342001
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Source of Monetary or Material Support  
Dr S N Medical College Jodhpur  
 
Primary Sponsor  
Name  Dr S N Medical Collage and attached hospital Jodhpur  
Address  Shastri Nagar Jodhpur Rajasthan 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Geeta Singariya  MDM hospital, Dr S N Medical Collage, Jodhpur  Main OT Complex, first floor, Department of Anaesthesia, MDM hospital, Dr. S.N. medical collage, Jodhpur
Jodhpur
RAJASTHAN 
9414803554

geetamanojkamal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr S N Medical College Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M970||Periprosthetic fracture around internal prosthetic hip joint, (2) ICD-10 Condition: M970||Periprosthetic fracture around internal prosthetic hip joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group FIC  Participants will receive fascia iliaca compartment block after spinal anesthesia, patients will receive 30 ml of 0.5% levobupivacaine  
Comparator Agent  Group PENG  Participants will receive pericapsular nerve group block after spinal anesthesia, patients will receive 30 ml of 0.5% levobupivacaine  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ASA physical status I and II undergoing hip surgeries (duration about 2.5 hours) 
 
ExclusionCriteria 
Details  Patient refusal
Uncooperative patient
Hypersensitivity to local amide anaesthetics Infection at the injection site
Pregnant woman
Obesity
Uncooperative patients
Prior surgery at the corresponding area
Bleeding disorders
Peripheral neuropathy or neurological deficit Known hepatic or renal insufficiency
Patient on concurrent chronic opioid or any other analgesic therapy,  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of analgesia after ultrasound-guided Fascia iliaca compartment (FIC) block and Pericapsular Nerve Group (PENG) block on the postoperative analgesia in patients undergoing hip surgeries  24 HOURS 
 
Secondary Outcome  
Outcome  TimePoints 
1. Analgesic consumption in post operative 24 hours
2. To assess quality of analgesia by using NRS score
3. Assessment of motor block during post operative 24 hours
4. Haemodynamic parameters
5. Complications
6. Patient satisfaction
 
24 HOURS 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   11/07/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 24-09-2022 and end date provided 24-09-2027?
    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  

The study will be conducted in Mahatama Gandhi hospital and Mathura Das Mathur Hospital of Dr S. N. Medical College and associated group of hospitals, Jodhpur after seeking clearance from the institutional ethical committee and obtaining written, informed consent from the patients. All patients will be examined during the preoperative visits, prior to surgery by an attending anesthesiologist. During the preoperative visit patient’s detailed history, general physical examination and systemic examination will be carried out. Basic demographic data like name, age, sex, height, and weight will be recorded. A detailed assessment of the airway will be performed to rule out any airway difficulty. Routine investigations will be carried out. Patients will be explained in detail about the procedure, drugs and the Numerical rating scale (NRS) ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain). The standard instruction of fasting will be given to all patients. After the arrival of the patient in the operation theatre, saturation monitors like continuous electrocardiogram (ECG), non-invasive blood pressure (NIBP) and peripheral oximetry will be applied on arrival to the operation theatre and baseline vitals will be recorded. A peripheral intravenous (IV) line will be secured with an 18 G cannula on the forearm and a 0.5ml/kg/hr crystalloid solution will be started. All the patients will receive spinal anaesthesia with 0.5% bupivacaine 15 mg (3 ml) heavy under all aseptic precautions. The block will be performed as per randomization, once the spinal anaesthesia effect is confirmed.

The block will be performed with an ultrasound machine. With the participants in a supine position, in group FIC block, the probe will place in a horizontal direction over the anterior part of the thigh just below the inguinal ligament. The ultrasound setting uses to visualise at a frequency of 10 MHz and a depth of 3-4 cm. The femoral artery will identify first. Group FIC, the iliacus muscle, covered by fascia iliaca will be identified lateral to the artery. A 20 G needle was then inserted in-plane into the ultrasound beam. The needle advance until the tip of the needle will place beneath the fascia iliaca and after negative aspiration, the local anaesthetic of 30 ml of 0.5% levobupivacaine will be injected and its spread visualized on the ultrasound screen

Group PENG block, the anterior inferior iliac spine, the femoral artery (FA), the pectineus muscle, the iliopubic eminence, the iliopsoas muscle and tendon could be observed using a curvilinear low-frequency ultrasound probe. The puncture site will be set 0.5-1.0 cm away from the lateral of the ultrasound probe. A 22-gauge, 80-mm needle will be inserted carefully in an in-plane approach from lateral to inner. Following the tip of the needle reaches the musculofascial between the tendon of the psoas muscle anteriorly and the pubic ramus posteriorly, which is between the iliopubic eminence and anterior inferior iliac spine, 1 mL of 0.9% saline solution will be injected to ensure that the solution will be spread in the plane beneath the iliopsoas muscle. After negative aspiration, a total volume of 30mL of 0.5% levobupivacaine will be slowly injected after negative aspiration every 5 mL. The ultrasound view of the fluid spread in the plane will be observed to ensure that the LA is injected right into the targeted location. 

 
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