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CTRI Number  CTRI/2021/08/035976 [Registered on: 26/08/2021] Trial Registered Prospectively
Last Modified On: 20/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   “Comparative evaluation of 2 Nerve Blocks (Ultrasound Guided Pericapsular Nerve Group Block with Femoral Nerve Block) for reducing pain associated with positioning for subarachnoid block in patients undergoing hip fracture surgery”. 
Scientific Title of Study   Comparative evaluation of Ultrasound Guided Pericapsular Nerve Group Block with Femoral Nerve Block for reducing pain associated with positioning for subarachnoid block in patients undergoing hip fracture surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Animesh Tah 
Designation  Post graduate resident  
Affiliation  Safdarjung Hospital and Vardhman Mahavir Medical College 
Address  Department of Anaesthesia and Intensive care ,Ground floor,Main operation theatre building,Safdarjung Hospital and Vardhman Mahavir Medical College,New Delhi

New Delhi
DELHI
110029
India 
Phone  7982575566  
Fax    
Email  animeshtah1995@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nidhi Agrawal 
Designation  Specialist Grade 1(Anaesthesia) 
Affiliation  Safdarjung Hospital and Vardhman Mahavir Medical College 
Address  Department of Anaesthesia and Intensive care ,Ground floor,Main operation theatre building,Safdarjung Hospital and Vardhman Mahavir Medical College,New Delhi

New Delhi
DELHI
110029
India 
Phone  9811030408  
Fax    
Email  nidhi.agrawal1970@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Animesh Tah 
Designation  Post graduate Resident  
Affiliation  Safdarjung Hospital and Vardhman Mahavir Medical College 
Address  Department of Anaesthesia and Intensive care ,Ground floor,Main operation theatre building,Safdarjung Hospital and Vardhman Mahavir Medical College,New Delhi

New Delhi
DELHI
110029
India 
Phone  7982575566  
Fax    
Email  animeshtah1995@gmail.com  
 
Source of Monetary or Material Support  
Safdarjung hospital and Vardhman Mahavir Medical College,New Delhi,India 
 
Primary Sponsor  
Name  Safdarjung hospital and Vardhman Mahavir Medical CollegeNew DelhiIndia 
Address  Department of Anaesthesia and intensive care. Ground floor, main operation theatre building. Safdarjung hospital and Vardhman Mahavir Medical College, New Delhi 110029  
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 
Animesh Tah  Safdarjung Hospital   Department of Anaesthesia and intensive care. Ground floor, main operation theatre building. New Delhi 110029
New Delhi
DELHI 
7982575566

animeshtah1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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  Ultrasound guided femoral nerve group block  Femoral block will be performed with the patient in the supine position. Using strict aseptic precautions a linear transverse high frequency probe(8-18 MHz M Turbo Sonosite) will be positioned over the femoral crease to identify the femoral artery and nerve. If the nerve is not immediately apparent lateral to the artery, the transducer will be tilted proximally or distally to highlight the nerve from the iliacus muscle and the more superficial adipose tissue. In doing so, an effort will be made to identify the iliacus muscle and its fascia, as well as the fascia lata. Once the femoral nerve is identified, a skin wheal of local anaesthetic will be made 1 cm away from the lateral edge of the transducer. The 80mm long , 22 gauge echogenic needle will be inserted in-plane in a lateral to medial orientation and advanced toward the femoral nerve after piercing fascia lata and layer of fascia iliaca. After negative aspiration 20 ml of 0.5% ropivacaine will be injected and spread of the drug will be noted by displacement of the femoral nerve. 
Intervention  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 0.5% ropivcaine) will be injected in 5-mL increments while observing for adequate fluid spread in this plane. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients with American Society of Anaesthesiologist (ASA) physical status grade I & II scheduled for surgery for hip fracture under subarachnoid block. 
 
ExclusionCriteria 
Details  1.Patients who can sit comfortably
2. Having contraindication for subarachnoid bock
3.Known allergy to local anesthetic drugs
4.Pre-existing peripheral nerve neuropathies
5.Having multiple fractures
6.Receiving chronic analgesic therapy
7.With infection over injection site
8. Hypotension
9. Impaired cognition. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual Analog Scale (VAS) score is a standard 10 cm line with 0 corresponding to no pain and 10 designating the worst possible pain.
VAS will be assessed and noted before the administration of block at rest and at dynamic hip movement of affected limb by straight leg raise of 15 degrees above table . VAS after the administration of the block will be assessed at rest at 5, 10, 20 and 30 minutes and then during positioning for subarachnoid block 30 minutes after the block.  

1.Before the administration of Peripheral nerve block at rest and dynamic hip movement.
2.After the administration of Peripheral nerve block at rest
3.After the administration of Peripheral nerve block at 5 min
4.After the administration of Peripheral nerve block at 10 min.
5.After the administration of Peripheral nerve block at 20 min.
6.After the administration of Peripheral nerve block at 30 min.
7.While positioning for subarachnoid block.
 
 
Secondary Outcome  
Outcome  TimePoints 
Total amount of fentanyl required for decreasing VAS to less than 4 during positioning for subarachnoid block will be noted.  While positioning for subarachnoid block. 
Quality of patient position for subarachnoid block as assessed by anesthesiologist performing subarachnoid block will be evaluated.  While performing subarachnoid block. 
Time taken for performing subarachnoid block measured from the start of positioning maneuvers to the spinal needle removal.  While performing subarachnoid block. 
Heart rate, non invasive blood pressure( systolic ,diastolic, Mean), respiratory rate and SpO2 will be recorded at 5,10 and 20 , 30 minutes after performing the block procedure and at positioning for subarachnoid block.  Before block;5,10,20,30 min after block; While positioning for subarachnoid block 
Complications such as hypotension (a decrease of mean blood pressure 20% from preanaesthetic baseline values), bradycardia (HR 50 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 hemodynamics will be monitored.   Post surgery observation. 
Patient satisfaction score will be noted after 24 hours of performance of analgesic block   24 hours after the block. 
 
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)   01/09/2021 
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   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This prospective randomised study has been designed to evaluate and compare the efficacy of ultrasound guided pericapsular nerve group block with that of ultrasound guided femoral nerve block for reducing pain associated with positioning for subarachnoid block in patients undergoing surgery for hip fracture.

We hypothesise that Ultrasound guided Pericapsular nerve group block is  more efficacious than ultrasound guided femoral nerve  block for reducing pain associated with positioning for subarachnoid block in  patients undergoing surgery for hip fracture.

The study will be conducted on 60 adult patients ( 18-60 years of age) of either sex, ASA grades 1 & 2 scheduled  for surgery  for  hip fracture under subarachnoid block.

Patients will be randomly allocated to two groups of 30 each using

Computer generated random number table  in two groups P&F. Allocations will be concealed in sealed numbered opaque envelopes, where F represents group receiving femoral nerve block and P represents group receiving PENG block. Once a patient will consent to enter a trial , an envelope will be opened and the patient will then be offered the allocated group.

Group P (N=30) : Patients will  receive ultrasound guided pericapsular nerve group block with 20 ml of 0.5% ropivacaine. 

Group F (N=30): Patients  will receive ultrasound guided femoral nerve block with 20 ml of 0.5% ropivacaine . All the patients will undergo detailed pre anaesthetic checkup and relevant investigations.

Patients will be examined one day prior to surgery and subjected to complete physical as well as systemic examination . All the patients will be made to fast overnight. The purpose of the

study, advantages and side effects of both the techniques of the study will be explained to patients and informed written consent will be obtained.

Preoperatively the patients will be familiarized with visual analog scale (VAS) pain score and its use in pain assessment.

Upon arrival in the room for block performance, standard monitoring including heart rate (HR), noninvasive blood pressure (NIBP), electrocardiography (ECG) and pulse oximetry (SpO2) will be established. Intravenous line will be secured with 18 G venous cannula. Ringer lactate  infusion will be started and a nasal cannula will provide oxygen  (3L/min). No sedative or analgesic medications will be administered.

Equipment and drugs required for providing general anaesthesia ,emergency resuscitation, and ultrasound guided nerve blocks will be kept ready.

Visual Analog Scale (VAS) score will be assessed and noted using a standard 10 cm VAS with 0 corresponding to no pain and 10 designating the worst possible pain before the block at rest and at dynamic hip movement of affected limb (straight leg raise of 15degrees above table) .20

Patients will be administered either of the blocks according to group allocation.

Heart rate, non invasive blood pressure (systolic ,diastolic, mean), respiratory rate and SpO2 will be recorded at 5,10 and 20 , 30 minutes after performing the block procedure and at positioning for subarachnoid block and monitored continuously while performing the block and during perioperative period.

Procedure: 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 0.5% ropivcaine) will be injected in 5-mL increments while observing for adequate fluid spread in this plane.13

Procedure: For ultrasound guided femoral nerve group block

Femoral block will be performed  with the patient in the supine position. Using strict aseptic precautions a linear transverse high frequency probe(8-18 MHz M Turbo Sonosite)  will be positioned over the femoral crease to identify the femoral artery and nerve. If the nerve is not immediately apparent lateral to the artery,  the transducer will be tilted proximally or distally to highlight the nerve from the iliacus muscle and the more superficial adipose tissue. In doing so, an effort will be made to identify the iliacus muscle and its fascia, as well as the fascia lata. Once the femoral nerve is identified, a skin wheal of local anaesthetic will be made 1 cm away from the lateral edge of the transducer. The 80mm long , 22 gauge echogenic  needle will be  inserted in-plane in a lateral to medial orientation and advanced toward the femoral nerve after piercing fascia lata and layer of fascia iliaca. After negative aspiration 20 ml of 0.5% ropivacaine will be injected and spread of the drug will be noted by displacement of  the femoral nerve.19

After 20 min patient will be moved to operating room. Patient will be made to sit up for positioning for subarachnoid block 30 minutes after administration of the analgesic  block.

Subarachnoid block will be performed using a median or paramedian approach at the L3-L4 or L4-L5 interspace using spinal needle.

PENG block and femoral nerve blocks will be given by an anaesthesiologist who would have performed both the blocks 10 times before starting the study cases. Observation for various parameters will be done by other anaesthesiologists blinded to the type of block given.

If the patient reports a VAS score ≥4 during positioning, procedure will be stopped,intravenous fentanyl 0.5 μg/kg will be given and  positioning will be re-attempted after 5 minutes. reduction of VAS to less than 4 by giving intravenous  0.5 μg/kg of inj. fentanyl every 5 minutes repeated up to maximum of 3 doses..

 

Primary objective is to compare the analgesia provided by  ultrasound guided pericapsular nerve group block with that of ultrasound guided femoral nerve block on positioning for subarachnoid block in patients undergoing surgery for hip fracture using visual analog scale (VAS)  score for pain.

Secondary objective: Quality of patient’s position for subarachnoid block , Total amount of fentanyl required during positioning for subarachnoid block, Time taken for performing subarachnoid block, Patient’s satisfaction with the  nerve block .

 

 

 

 
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