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CTRI Number  CTRI/2017/08/009523 [Registered on: 29/08/2017] Trial Registered Retrospectively
Last Modified On: 25/08/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Pre-operative pain relief in hip fractures- which is better? Femoral Nerve Block vs Fascia Iliaca Block 
Scientific Title of Study   To compare the analgesic efficacy and hemodynamic stability in femoral block and fascia iliaca block in pre-operative pain management of patients with hip fractures. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Janani A M 
Designation  MBBS DNB Anaesthesia 
Affiliation  Ganga Medical Centre and Hospital 
Address  Ganga Medical Center and Hospital, Department of Anesthesiology, 5th Floor Operation theater complex, 313 Mettupalayam Road Opposite Saibaba koil

Coimbatore
TAMIL NADU
641043
India 
Phone  9944931128  
Fax    
Email  janani.murli@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Janani A M 
Designation  MBBS DNB Anaesthesia 
Affiliation  Ganga Medical Centre and Hospital 
Address  Ganga Medical Center and Hospital, Department of Anesthesiology, 5th Floor Operation theater complex, 313 Mettupalayam Road Opposite Saibaba koil

Coimbatore
TAMIL NADU
641043
India 
Phone  9944931128  
Fax    
Email  janani.murli@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr V M Balasubramani 
Designation  Chief, trauma intensive care 
Affiliation  Ganga Medical Center and Hospital 
Address  Ganga Medical Center and Hospital, Department of Anesthesiology, 5th Floor Operation theater complex, 313 Mettupalayam Road Opposite Saibaba koil

Coimbatore
TAMIL NADU
641043
India 
Phone    
Fax    
Email  vmbalasubramani@hotmail.com  
 
Source of Monetary or Material Support  
Ganga Hospital,313 mettupalayam road, sai baba colony Coimbatore 641043 Tamilnadu  
 
Primary Sponsor  
Name  Ganga Medical Centre and Hospital 
Address  313, mettupalayam Road, Opp to Sai Baba Temple, Coimbatore- 641043 
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 Janani Murli  Ganga Hospital, Coimbatore  Department of Orthopedic and Trauma, 5th floor preoperative room
Coimbatore
TAMIL NADU 
9944931128

janani.murli@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients having hip fractures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fascia Iliaca block  Fascia iliaca Nerve Block was performed using 0.25% bupivacaine (according to the weight 3mg/kg) with 8mg dexamethasone under combined ultrasonography and peripheral nerve stimulation guidance and patients were assessed for 24 hours following nerve block for pain relief. 
Intervention  Femoral nerve block  Femoral Nerve Block was performed using 0.25% bupivacaine (According to the weight 3 mg/kg) with 8mg Dexamethasone under combined ultrasonography and peripheral nerve stimulation guidance and patients were assessed for 24 hours following nerve block for pain relief. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1) All patients with isolated hip fracture
2) Patients of ASA physical Status I, II and III
3) Patients who have not been subjected to other analgesics after the fracture
4) Patients who are oriented to give consent.
 
 
ExclusionCriteria 
Details  1) Pathological and periprosthetic hip fractures
2) Patients allergic to local anesthetics
3) Recent vascular injury involving the lower limb
4) Bleeding diathesis, patients on anti-platelets
5) Patients who shall be taken up for surgery within 18 hours
6) Patients less than 18 years of age
7) Patients more than 90 years of age
8) Hemodynamically compromised patients
9) Non consenting patients / relative refusal for procedure
10) Patients in ASA physical status class IV
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
VAS score less than 3  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Motor Blockade, Sensory Blockade, Duration, Rescue analgesia, Side effect  24 Hours 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/03/2014 
Date of Study Completion (India) 10/08/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The study comprised of hundred patients (50 in each group) of the age group 18-90 years, of either sex, suffering from hip fracture categorized under American Society of Anaesthesiologists (ASA) physical status I, II& III, after the conditions of the inclusion and exclusion criteria were satisfied. They were divided into 2 groups using the computerized randomization technique as follows: Group A (N=50) Femoral Nerve Block was performed using 0.25% bupivacaine (According to the weight) with 8mg dexamethasone under combined ultrasonography and peripheral nerve stimulation guidance and Group B (N=50) Fascia iliaca Nerve Block was performed using 0.25% bupivacaine (according to the weight) with 8mg dexamethasone under combined ultrasonography and peripheral nerve stimulation guidance. The study aims to compare the onset, duration of sensory and motor block, duration of analgesia, hemodynamic stability and need of rescue analgesia.

 

The aim of the study is to compare analgesic efficacy and hemodynamic stability in femoral nerve block versus fascia iliaca block as pain management in hip fractures during the pre-operative period, with objectives  to determine Time of onset and duration of sensory block, time of onset and duration of motor block, Range and duration of analgesia, Efficacy of analgesia using VAS assessment scale at rest and at movement and the number of rescue analgesics required in these patients, Hemodynamic stability in terms of heart rate, blood pressure, saturation for a period of 24 hours.

          Result of our study showed that in the pre- operative period, prolonged duration of analgesia with better hemodynamic stability is better achieved in femoral nerve block group than the fascia iliaca block group. Femoral nerve block administration resulted in lower VAS both at rest and during passive hip flexion of 15 degree, longer duration of sensory and motor block, Longer duration of analgesia and decreased amount of rescue analgesics as compared to fascia iliaca block. Though fascia iliaca block gives a better pain relief during the first two hours longer and better pain control in given by femoral block. Both the blocks provided good hemodynamic stability. Thus we conclude that femoral nerve block is better than fascia iliaca block in pain management pre-operatively for hip fractures, whereas fascia iliaca can be preferred just before surgery for positioning and for pain relief during the surgical incision.

 
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