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CTRI Number  CTRI/2023/07/054945 [Registered on: 07/07/2023] Trial Registered Prospectively
Last Modified On: 06/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparing two different nerve Blocks for Reducing Pain in Patients with Hip Fracture before Positioning for Subarachnoid Block. 
Scientific Title of Study   Comparison of Ultrasound Guided Pericapsular Nerve Group Block with Suprainguinal Fascia Iliaca Block for Reducing Pain in Patients with Hip Fracture before Positioning for Subarachnoid Block. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prachi Ranjan 
Designation  Post Graduate Resident 
Affiliation  Vardhman Mahavir College And Safdarjung Hospital 
Address  Department Of Anaesthesia Vardhman Mahavir Medical College And Safdarjung Hospital New Delhi

South
DELHI
110029
India 
Phone  7908277893  
Fax    
Email  prachifcb3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nidhi Agrawal 
Designation  Professor & Consultant 
Affiliation  Department Of Anaesthesia Vardhman Mahavir Medical College And Safdarjung Hospital  
Address  Department Of Anaesthesia Vardhman Mahavir Medical College And Safdarjung Hospital New Delhi

South
DELHI
110029
India 
Phone  9811030408  
Fax    
Email  nidhi.agrawal1970@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nidhi Agrawal 
Designation  Professor & Consultant 
Affiliation  Department Of Anaesthesia Vardhman Mahavir Medical College And Safdarjung Hospital  
Address  Department Of Anaesthesia Vardhman Mahavir Medical College And Safdarjung Hospital New Delhi

South
DELHI
110029
India 
Phone  9811030408  
Fax    
Email  nidhi.agrawal1970@gmail.com  
 
Source of Monetary or Material Support  
Department Of Anaesthesia Vardhman Mahavir Medical College And Safdarjung Hospital New Delhi 
 
Primary Sponsor  
Name  Prachi Ranjan 
Address  Department of Anaesthesia Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi- 110029 
Type of Sponsor  Other [SELF] 
 
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 
Prachi Ranjan  Vardhman Mahavir College And Safdarjung Hospital  Department Of Anaesthesia, Ground floor, Main OT Building.
South
DELHI 
7908277893

prachifcb3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, Vardhaman Mahavir College and Safdargunj Hospital  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, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: M20-M25||Other joint disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ULTRASOUND GUIDED PERICAPSULAR NERVE GROUP BLOCK  : For ultrasound guided pericapsular nerve group block The regional block will be performed with the patient in the supine position. Using strict aseptic precautions a curvilinear low-frequency ultrasound probe (2-5 MHz, M Turbo, SonoSite Inc., USA) will be initially placed in the transverse plane over the anterior inferior iliac spine and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view the iliopubic eminence, the iliopsoas muscle and tendon, the femoral artery and pectineus muscle will be observed. A skin wheal of local anaesthetic will be made 1 cm away from the lateral edge of the ultrasound probe. A 22-gauge, 100-mm long echogenic needle will be inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anaesthetic solution (20 ml of 0.25% bupivcaine) will be injected in 5-mL increments while observing for adequate fluid spread in this plane. Duration of procedure is 20-30 minutes.  
Comparator Agent  ULTRASOUND GUUIDED SUPRAINGUINAL FASCIA ILIACA BLOCK  Ultrasound guided suprainguinal fascia iliaca block The suprainguinal approach to the FICB has also been described using a more proximal needle insertion point.With the patient supine, a linear high frequency probe (6-14 MHz)is placed in the sagittal plane to obtain an image of the ASIS.The probe is moved medially and the fascia iliaca and sartorius, iliopsoas, and internal oblique muscles are identified. After identifying the ‘bowtie sign’ formed by the muscle fasciae, a 100 mm needle is introduced from caudal to cephalad using an in plane approach. The needle tip is positioned beneath the fascia iliaca,cephalad to inguinal ligament and hydro-dissection isused to separate the fascia iliaca from the iliacus muscle. The needle is further advanced in this space in a cranial and slightly dorsal direction. The deep circumflex artery lies superficial to the fascia iliaca and upward movement of this artery upon injection can be used as a marker of fascia iliaca penetration. Following negative aspiration, the local anesthetic solution (30 ml of 0.25% bupivacaine) will be injected in 5 ml increments while observing for adequate fluid spread in this plane. An injection is considered successful if spread of local anaesthetic is observed cranial to the point where the iliac muscle passes under the abdominal muscles. Duration of procedure is 20-30 minutes.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Study will be conducted in patients in age group of 18 to 80 years belonging to American society of Anaesthesiologist (ASA) physical status I and II scheduled for Hip fracture surgery under Subarachnoid block 
 
ExclusionCriteria 
Details  Patients who can sit comfortably without requirement of analgesia
Patients having contraindication for Subarachnoid block
Patients with known allergy to local anesthetic drugs
Patients with Pre-existing peripheral nerve neuropathies and having fractures in multiple bones
Patients receiving chronic analgesic Therapy
Patients with infection over injection site
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Compare Analgesia provided by ultrasound guided pericapsular nerve group block with that of suprainguinal fascia Iliaca block measured by numerical rating scale score on passive limb elevation of 15 degrees at 30 minutes post block in patients with hip fracture before positioning for subarachnoid block.   Before the block & at 30 minutes after the block 
 
Secondary Outcome  
Outcome  TimePoints 
Total amount of supplemental fentanyl if required to reduce pain on 15 degrees limb elevation at 30 minutes after administration of block.
NRS score on positioning patient for subarachnoid block
Ease of positioning score
Quality of patient’s position for subarachnoid block
Patient’s satisfaction with the nerve block
 
30 minutes after the block  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   20/07/2023 
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="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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

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

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [prachifcb3@gmail.com].

  6. For how long will this data be available start date provided 01-07-2023 and end date provided 08-01-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This study is a Prospective randomized interventional comparative study with an aim to to compare analgesia provided by ultrasound guided pericapsular nerve group block with that of suprainguinal fascia iliaca block  in patients with hip fracture before positioning for subarachnoid block.This study will be done in single centre in india. In this study-

1.Pre Procedural pain will be assessed during rest as well as movement of 15° passive elevation of affected limb and recorded on numeric pain rating scale (NRS) 0=no pain,10=worst imaginable pain.

2. At 30mins after administering the block, pain will be measured by NRS at rest and on passive limb elevation of 15°. (Primary objective)

If the patient reports a NRS score ≥4 during 15° passive elevation of affected limb, intravenous fentanyl 0.5 μg/kg body weight will be given and 15° passive elevation of affected limb will be re-attempted after 5 minutes. If still NRS score is ≥4 then Inj. fentanyl 0.5 μg/kg body weight will be repeated every 5 minutes up to maximum of 3 doses.

3. Patient will be made to sit up for positioning for subarachnoid block after NRS score on 15 degree passive limb elevation is < 4 or after 3 doses of fentanyl have been given and NRS pain score  will be noted on sitting up the patient for positioning for subarachnoid block.

4. Total amount of supplemental fentanyl if required for decreasing NRS pain score on 15° passive elevation of affected limb at 30 minutes after administration of block will be noted.

5. The ease of spinal positioning (EOSP) will be assessed on the scale of 0–3 (0 = unable to position, 1 = patient had abnormal posturing due to pain and required support for positioning, 2 = mild discomfort but does not require support for positioning, 3 = optimal condition where the patient was able to position himself without pain).

6. Quality of patient position for subarachnoid block as assessed by anaesthesiologist performing subarachnoid block will be evaluated as

0=Unsatisfactory, 1=Satisfactory, 2=Good or 3=Optimal.

Subarachnoid  block will be performed using a median or paramedian approach at the L3-L4 or L4-L5 interspace using spinal needle using 3 ml of 0.5% bupivacaine + fentanyl 10 µg.

7. Heart rate, non invasive blood pressure (systolic ,diastolic, Mean), respiratory rate and SpO2 will be recorded ; a) at rest at 5, 10 ,20, 30 minutes after performing the block procedure, b) on  15 degree passive limb elevation at 30 minutes after performing the block and c) on positioning patient ( in sitting up position ) for subarachnoid block.

 Intraoperative monitoring of heart rate, noninvasive blood pressure (systolic, diastolic and mean) and SpO2 will be done.

8. Complications such as hypotension (a decrease of mean blood pressure >20% from preanaesthetic baseline values), bradycardia (HR <40 beats/min), hypoventilation (breathing rate <8 breaths/min), nausea and vomiting and signs of LA toxicity will be noted and treated. After surgery, all patients will be transferred to post anesthesia care unit, and hemodynamic parameters will be monitored. All patients will receive paracetamol 1gm intraveously 8 hourly.

9.Patient satisfaction score will be noted after positioning patient in sitting up position for subarachnoid block:

Score 1- Good (Will definitely accept the block again in future if required).

Score 2- Poor (will never accept the block again in future if required).

 

 
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