FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/10/058539 [Registered on: 11/10/2023] Trial Registered Prospectively
Last Modified On: 04/10/2023
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   Assessment of pain relief after giving local anaesthesia in two different approaches for patient positioning before spinal anaesthesia in thigh bone fractures 
Scientific Title of Study   Comparative study of ultra sound(USG) guided fascia iliaca block and quadratus lumborum block for patient positioning prior to spinal anaesthesia in proximal femur fracture surgeries: A prospective randomised comparative study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  B Sarath Chandra  
Designation  Junior Resident 
Affiliation  Rajarajeshwari medical college and hospital 
Address  Department of anaesthesiology Rajarajeshwari medical college and hospital, kambipura, Mysore Road, Bangalore, Karnataka 560074

Bangalore
KARNATAKA
560074
India 
Phone  9491935823  
Fax    
Email  sarathchandra567@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shankar K 
Designation  Assistant Professor 
Affiliation  Rajarajeshwari medical college and hospital 
Address  Department of anaesthesiology Rajarajeshwari medical college and hospital, kambipura, Mysore Road, Bangalore, Karnataka 560074

Bangalore
KARNATAKA
560074
India 
Phone  8971719523  
Fax    
Email  shankarkraj111@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sowmya M J 
Designation  Professor 
Affiliation  Rajarajeshwari medical college and hospital 
Address  Department of Anaesthesiology Rajarajeshwari medical college and hospital, kambipura, Mysore Road, Bangalore, Karnataka 560074

Bangalore
KARNATAKA
560074
India 
Phone  9880574092  
Fax    
Email  drsowmyamj80@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeshwari medical college and hospital Kambipura Mysore Road Bangalore Karnataka 560074  
 
Primary Sponsor  
Name  Rajarajeshwari medical college and hospital  
Address  Kambipura Mysore Road Bangalore Karnataka 560074 
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 
B SARATH CHANDRA  Rajarajeshwari medical college and hospital  2nd floor Department of Anaesthesia Kambipura Mysore road Bangalore Karnataka 560074
Bangalore
KARNATAKA 
9491935823

sarathchandra567@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE, RAJARAJESWARI MEDICAL COLLEGE AND HOSPITAL  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 
Intervention  Fascia iliaca block  Group A will receive Fascia ilia a block before spinal anaesthesia. In Group A, with patient in supine position, with limb kept in resting position, the suprainguinal anatomy will be ascertained with probe placement in the suprainguinal region. Using high frequency linear probe (7 – 15 Hz), the fascia iliaca compartment is approached below as well as above the inguinal ligament. The femoral artery and the iliacus muscle lateral to it, covered by the fascia iliaca will be identified. If the division of the femoral artery visualized, the probe will be moved more cranially. In plane technique is used for needle insertion. The needle is advanced until the tip is placed underneath the fascia iliaca (appreciating the pop sensation as the fascia perforates) and negative aspiration will be confirmed, then 25 mL of 0.25% of bupivacaine will be injected. Total duration of intervention is 10minutes. 
Comparator Agent  Quadratus lumborum block  In group-B, patient will be kept in supine position, moved to edge of the bed and a small bolster kept under the buttock, so that the affected side will be easily accessed for placement of probe and needle insertion. 25ml of 0.25% of bupivacaine will be administerd in the lateral aspect of the quadratus lumborum muscle placing the high frequency linear transducer (7 – 15 Hz) on the midaxillary line, between the 12th rib and the iliac crest, the abdominal muscles (external oblique, internal oblique and transversus abdominis) are identified, and the quadratus lumborum muscle, posterior to them. The needle will be inserted in plane approach so as to place the tip anterolateral to the border of quadratus lumborum muscle and local anaesthetic solution will be injected after negative aspiration for blood. Total duration of intervention 10minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with normal BMI aged 18-80years of either gender with American Society of Anaesthesiologists (ASA) I, IIand III status undergoing proximal femur fracture surgeries under spinal anaesthesia 
 
ExclusionCriteria 
Details  Patient who could sit comfortably
Patient refusing to participate in the study
If drug fail to act
ASA IV
Local anaesthetic allergy
Coagulopathy
Infection at the site of block,
Neuro‐psychiatric disorders
Pregnant or lactating mothers.
Peripheral neuropathy
Poly trauma patients
Femoral graft in the affected limb
Patients with head injury and peripheral vascular disease.
BMI >30 
 
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 
To assess the analgesic efficacy of pre operative USG-guided fascia iliaca block & Quadratus Lumborum block for patient positioning prior to spinal anaesthesia in proximal femur fracture surgeries  VAS score 20min after block & during positioning  
 
Secondary Outcome  
Outcome  TimePoints 
To compare intraoperative & postoperative analgesic requirement for 24hours, duration of postoperative analgesia, time for mobility in both the groups
Comparison of haemodynamic parameters
Complications if any 
Intraoperative & postoperative VAS score for 24 hours 
 
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 4 
Date of First Enrollment (India)   16/10/2023 
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 - NO
Brief Summary  

Proximal femur fracture surgeries are painful in preoperative period and is associated with morbidity especially in the elderly, due to underlying osteoporosis and presence of other coexisting diseases. Subarachnoid block is the choice of anaesthesia for fracture femur surgeries, but pain can interfere with optimal positioning for administration of spinal anaesthesia. Current methods of providing pre-and post-operative analgesia include non-steroidal anti-inflammatory drugs (NSAIDS), oral or parenteral opioids, and regional anaesthesia techniques.Hence, present study is designed to compare the efficacy of Fascia iliaca block with quadratus lumborum block for positioning and for post-operative analgesia in patients with proximal femur fractures. Aim is to assess the analgesic efficacy of pre operative ultra sound( USG)guided fascia iliaca block and Quadratus Lumborum block for patient positioning prior to spinal anaesthesia in proximal femur fracture surgeries. After approval from institution ethical committee and written informed consent from all patients, this prospective randomised comparative study will be done on 50 patients with normal BMI aged 18-80years of either gender with American Society of Anaesthesiologists (ASA) I, II and III status undergoing proximal femur fracture surgeries under spinal anaesthesia. Simple randomisation will be done by computer generated random numbers and group allocation will be done by sealed envelope technique. Group A will receive USG - guided Fascia iliaca block using 25ml of injection 0.25 % of bupivacaine on ipsilateral side. Group B receive USG - guided Quadratus lumborum block using 25ml of injection 0.25% of bupivacaine on ipsilateral side. Hemodynamics (heart rate, blood pressure, SpO2) will be continuously monitored and recorded every 5minutes till the end of surgery. Post operative pain scores and analgesic consumption will be recorded for first 24hours. IV Paracetamol 1gm will be used as rescue analgesic.

 
Close