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CTRI Number  CTRI/2024/10/074902 [Registered on: 08/10/2024] Trial Registered Prospectively
Last Modified On: 28/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Pain Relief Methods for Elderly Patients with Hip Fractures: Single-Shot vs. Continuous Nerve Block Using Ropivacaine in the Emergency Room. 
Scientific Title of Study   "Analgesic Efficacy of Single-shot Versus Continuous Supra-inguinal Fascia Iliaca Compartment Block (S-FICB) using Ropivacaine for Elderly Proximal Femur Fracture patient ni the EmergencyDepartment: ARandomizedControledStudy." 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Subhasree Das 
Designation  Assistant Professor 
Affiliation  Department Of Trauma and Emergency,AIIMS Bhubaneswar 
Address  Trauma and Emergency office,Department of Trauma & Emergency.New Trauma Building. All India Institute Of Medical Sciences,Bhubaneswar
AIIMS,Bhubaneswar
Khordha
ORISSA
751019
India 
Phone  7978885193  
Fax    
Email  drkakalee@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Subhasree Das 
Designation  Assistant Professor 
Affiliation  Department Of Trauma and Emergency,AIIMS Bhubaneswar 
Address  Trauma and Emergency office,Department of Trauma & Emergency.New Trauma Building. All India Institute Of Medical Sciences,Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  7978885193  
Fax    
Email  drkakalee@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Subhasree Das 
Designation  Assistant Professor 
Affiliation  Department Of Trauma and Emergency,AIIMS Bhubaneswar 
Address  Trauma and Emergency office,Department of Trauma & Emergency.New Trauma Building. All India Institute Of Medical Sciences,Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  7978885193  
Fax    
Email  drkakalee@gmail.com  
 
Source of Monetary or Material Support  
AIIMS,BHUBANESWAR 
 
Primary Sponsor  
Name  AIIMSBHUBANESWAR 
Address  At-Sijua,PO.Patrapada,Bhubaneswar,Khorda,Odisha,India ,751019 
Type of Sponsor  Research institution and hospital 
 
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 Subhasree Das  AIIMS Bhubaneswar  Yellow zone of Trauma and Emergency ,Department of Trauma and Emergency,
Khordha
ORISSA 
7978885193

drkakalee@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE AIIMS BHUBANESWAR  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  continuous Suprainguinal Fascia Iliaca Block  will receive 30 ml of 0.2 % Ropivacaine followed by 7 ml/hr continuous infusion of 0.125% Ropivacaine by an elastomeric infusion pump after placement of continuous catheter in the intrafascial plane and it will be kept for 24 hr and patient will be observed for 24 hour. 
Intervention  single-shot Suprainguinal-Fascia Iliaca Compartment Block (S -FICB)  Single-shot Suprainguinal-Fascia Iliaca Compartment Block (S -FICB) will receive 30 ml of 0.2 % Ropivacaine under USG in Infascial plane and patient will be observed for 24 hour. 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients of either sex aged 60 years to 90 years with (ASA) physical status I-IV presenting to ED with acute proximal femur fracture 
 
ExclusionCriteria 
Details  Exclusion criteria:
1) other organ severe trauma with unstable hemodynamics at the presentation.
2) coagulation disorder
3) Taking Analgesics for a longer duration or with opioid addiction
4) History of allergy to local anesthetics
6) Having cognitive impairment.
7) Puncture site infection
8) Abnormal neurological status of the lower limbs
9) voluntary withdrawal by patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
We will evaluate the Visual Analogue Scale at rest. The baseline value (T0),30 minutes after procedure (T1),subsequently at 6 hours( T2),12 hours(T3) and 24 hours(T4) following the block.
 
We will evaluate the Visual Analogue Scale at rest. The baseline value (T0),30 minutes after procedure (T1),subsequently at 6 hours( T2),12 hours(T3) and 24 hours(T4) following the block.
 
 
Secondary Outcome  
Outcome  TimePoints 
MAP, HR, SPO2 at the time of evaluation of VAS
The amount of opioids as a rescue analgesia
Time for resque analgesia
Duration of sleep in 24-hr
Adverse effects related to LA, Block and related Catheter within 24 hours following the block.
 
At rest,30 minutes,6hr,12 hr ,24 hr following the procedure 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   19/10/2024 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Hip and proximal femur fractures, comprising 20% of all fractures in the elderly, are rising due to the aging population. Intense pain associated with proximal femur fractures can be worsened by position changes during examination, transport, or treatment. This augmented pain response can trigger adverse cardiovascular and cerebrovascular complications. 

The Fascia Iliac Block is increasingly used to reduce hip fracture pain. In recent years, USG -a guided supra-inguinal FICB approach has emerged as a novel method for performing FICB. It is safely performed with minimal risk as the needle trajectory does not cross major vessels, and the intended site of drug deposition is relatively superficial. The Supra inguinal approach, a recent advance over the conventional approach, ensures a more consistent spread of Local anesthetics (LA). It provides (80%) sensory blockade of the thigh than the previous method(30%).

The single-shot S-FICB provides analgesia for approximately eight hours, and few other studies show that its effect starts wearing off around 24 hrs. We wanted to prolong the analgesia period by inserting a catheter and providing continuous LA infusion through the elastomeric infusion system without electricity. It gives a consistent supply of drugs and does not require detachment during transportation.

Hence this study is designed to assess and compare the analgesic efficacy of USG-guided single-shot Suprainguinal Fascia Iliaca Compartment Block (S-FICB) to Continuous S-FICB  using a continuous catheter and infusing through an elastomeric infusion pump in elderly patients with proximal femur fracture presenting to to the Emergency Department (ED).

 

 
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