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CTRI Number  CTRI/2022/06/043059 [Registered on: 07/06/2022] Trial Registered Prospectively
Last Modified On: 29/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between Femoral Nerve Block and Fascia Iliaca Compartment Block for reducing pain associated with positioning for spinal anaesthesia in proximal femur fracture surgery. 
Scientific Title of Study   A Randomised Comparative Study Of Ultrasound Guided Femoral Nerve Block Vs Fascia Iliaca Compartment Block For Reducing Pain Associated With Positioning For Spinal Anesthesia In Patients With Proximal Femur Fracture At SMS Hospital, Jaipur. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mamta Khandelwal 
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College, Jaipur 
Address  Department Of Anaesthesiology, Second Floor, Dhanwantri Building, Sawai Man Singh Medical College, JLN Marg jaipur.

Jaipur
RAJASTHAN
302015
India 
Phone  9929338174  
Fax    
Email  drmamtakhandelwal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mamta Khandelwal 
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College, Jaipur 
Address  Department Of Anaesthesiology, Second Floor, Dhanwantri Building, Sawai Man Singh Medical College, JLN Marg jaipur.

Jaipur
RAJASTHAN
302015
India 
Phone  9929338174  
Fax    
Email  drmamtakhandelwal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kanupriya 
Designation  P.G Student 
Affiliation  Sawai Man Singh Medical College, Jaipur 
Address  Department Of Anaesthesiology, Second Floor, Dhanwantri Building, Sawai Man Singh Medical College, JLN Marg jaipur.

Jaipur
RAJASTHAN
302015
India 
Phone  9465920681  
Fax    
Email  kanupriya1095@gmail.com  
 
Source of Monetary or Material Support  
Department Of Anaesthesiology, SMS Hospital, Jaipur. 
 
Primary Sponsor  
Name  Sawai Man Singh Medical College Jaipur 
Address  Department Of Anaesthesiology, Second Floor, Dhanwantri OPD Block, Sawai Man Singh Medical College, JLN Marg, Jaipur 
Type of Sponsor  Government medical college 
 
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 Mamta Khandelwal  Sawai Man Singh Medical College And Hospital, Jaipur.  Department Of Anaesthesiology, Second Floor, Dhanwantri OPD Block, Sawai Man Singh Medical College And Hospital, JLN Marg, Jaipur.
Jaipur
RAJASTHAN 
9929338174

drmamtakhandelwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, SMS Medical College and Hospital, Jaipur.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  43 Patients will receive Ultrasound guided Fascia Iliaca Compartment Block with 30ml of 0.25% Bupivacaine.  Effect will be checked by pin prick sensation on anterior part of thigh. VAS Score will be recorded before and immediately after the block at every 1 min interval until VAS is less than 3. 
Comparator Agent  43 Patients will receive Ultrasound guided Femoral Nerve block with 15ml of 0.25% Bupivacaine.  Effect will be checked by pin prick sensation on anterior part of thigh. VAS Score will be recorded before and immediately after the block at every 1 min interval upto 15 min until VAS is less than 3. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patient undergoing elective surgery for proximal femur fracture unable to sit for SAB due to severe pain.(VAS >7)
2.Patients consenting to participate.
3.Adult patients aged 18-80 Years.
4.Patients belonging to American Society Of Anesthesiologists(ASA) grade I, II and III.
5.Weight 40-80 kgs. 
 
ExclusionCriteria 
Details  1.Patients with psychiatric illness, anxious, agitated.
2.Patients with peripheral sensorineural deficit.
3.Patients allergic to local anesthetics.
4.Patients on anticoagulant therapy.
5.Infection at block site.
6.Patients with multiple trauma.
7.Patients with suspected compartment syndrome in lower limbs.
8.Patients on analgesia within 8 hours before performing nerve block.
9.Block failure cases.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the change in VAS score from baseline to post induction at different time intervals.

 
To determine the change in VAS score from baseline to post induction at different time intervals maximum up to 15 minutes (until the VAS score is less than 3) in both groups.

 
 
Secondary Outcome  
Outcome  TimePoints 
1.To estimate Anesthesiologist satisfaction score.
2.To determine the difference in mean time of first rescue analgesia in both groups by using VAS score.
3.To determine the difference in mean dose of analgesia required in both groups.
4.To determine the change in the haemodynamic parameters (HR,SBP,DBP,MAP and SpO2 )in both groups.
5.To observe side effect if any.
 
1.To estimate Anesthesiologist satisfaction score.
2.To determine the difference in mean time of first rescue analgesia in both groups by using VAS score.
3.To determine the difference in mean dose of analgesia required for 24 hours in both groups.
4.To determine the change in the haemodynamic parameters (HR,SBP,DBP,MAP and SpO2 )in both groups.
5.To observe side effect if any.
 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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)   15/06/2022 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Patient randomization will be performed using computerized random number table, in which patient will be randomly allocated in a ratio of 1:1 to receive one of the two assigned blocks.

Group A (n = 43) will receive Femoral nerve Block with 15 mL of 0.25% bupivacaine).

Group B (n = 43) will receive Fascia iliaca compartment block with 30 mL of 0.25% bupivacaine).

Depending on the allotted group, patients will receive the block under the guidance of ultrasound in the Operation Theatre under all aseptic precautions.

Effect will be checked by pin prick on anterior part of thigh at every 2 min interval.  VAS (Visual Analogue Scale) Score will be recorded before the block and immediately after the block at every 1 min interval upto 15 min until VAS is <3. The time taken to achieve VAS <3 will be noted. When VAS Score is achieved<3 under all aseptic precautions SAB will be given in sitting position in L3-L4 space using 0.5% hyperbaric Bupivacaine 12.5mg +25mcg of fentanyl using 25 gauze quinke’s needle. When adequate sensory and motor blockade will be achieved, surgery will be started. Intraoperative parameters such as Heart Rate, SBP, DBP, MAP andSpo2 will be monitored according to proforma.

 

When surgery will  complete patient will be shifted to PACU. Inj. Tramadol  100 mg will be given as rescue analgesia. Time for the need of first rescue  analgesia will be noted. This time will be calculated from VAS<3 after the block to request of first rescue analgesia by patient at VAS >3.VAS Score will  be assessed at hourly interval for first 6 hrs., 2 hrly interval for 12hrs, 4 hrly interval for 24 hrs.Total dose of Tramadol required in 24hrs will be noted. Anesthesiologist Satisfaction Score, and Patient’s satisfaction score will be  assessed.Side effect if develop will be noted and managed accordingly.

 
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