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CTRI Number  CTRI/2022/01/039069 [Registered on: 03/01/2022] Trial Registered Prospectively
Last Modified On: 30/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   To study the potency of pain relief provided by the nerve block given with two drugs under ultrasound guidance in patients who have thigh bone fracture before positioning them for spinal anaesthesia. 
Scientific Title of Study   To study the efficacy of ultrasound guided fascia iliaca compartment block with bupivacaine and dexmedetomidine for positioning before spinal anaesthesia in fracture femur patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sahana S 
Designation  Post graduate 
Affiliation  DR. B. R. AMBEDKAR MEDICAL COLLEGE AND HOSPITAL 
Address  OT Complex, 1st floor, Department of Anaesthesiology, Dr B R Ambedkar Medical College and Hospital, KG Halli, Bengaluru

Bangalore
KARNATAKA
560045
India 
Phone  7483107484  
Fax    
Email  sahana.suresh7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Harsoor S S 
Designation  Head of the department 
Affiliation  DR. B. R. AMBEDKAR MEDICAL COLLEGE AND HOSPITAL 
Address  OT Complex, 1st floor, Department of Anaesthesiology, Dr B R Ambedkar Medical College and Hospital, KG Halli, Bengaluru

Bangalore
KARNATAKA
560045
India 
Phone  9845279426  
Fax    
Email  harsoorss@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sahana S 
Designation  Post graduate 
Affiliation  DR. B. R. AMBEDKAR MEDICAL COLLEGE AND HOSPITAL 
Address  OT Complex, 1st floor, Department of Anaesthesiology, Dr B R Ambedkar Medical College and Hospital, KG Halli, Bengaluru

Bangalore
KARNATAKA
560045
India 
Phone  7483107484  
Fax    
Email  sahana.suresh7@gmail.com  
 
Source of Monetary or Material Support  
Dr B R Ambedkar Medical College and Hospital 
 
Primary Sponsor  
Name  Dr Sahana S 
Address  OT complex, 1st floor, Department of anaesthesiology, Dr B R Ambedkar Medical College and Hospital, KG halli, Bengaluru - 560045 
Type of Sponsor  Other [Self] 
 
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 Sahana S  DR B R Ambedkar Medical College and Hospital  OT complex, 1st floor, Department of Anaesthesiology, Dr B R Ambedkar Medical College and Hospital,KG Halli, Bengaluru
Bangalore
KARNATAKA 
7483107484

sahana.suresh7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics Committee Dr B R Ambedkar 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: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  Fascia iliaca compartment block is generally given with only a local anaesthetic agent. As an intervention, an adjuvant, dexmedetomidine is added along with local anaesthetic agent with a dosage of 0.5 mcg/kg and observed for ease of positioning the patient for spinal anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  Patients posted for surgeries for femur fracture. American Society of Anaesthesiologists (ASA) class 1 and 2 patients. 
 
ExclusionCriteria 
Details  Patients with history of kown allergy to bupivacaine or dexmedetomidine, pregnancy and lactation, pre-existing neurological conditions, alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate the informed consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
pain score in terms of visual analogue scale and numerical rating scale of lesser than or equal to 3  20 minutes after fascia iliaca compartment block, during positioning for spinal anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
to assess the sedation in terms of Ramsay Sedation Score  perioperative period 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   01/01/2022 
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="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  

Lower limb fractures like fracture femur pose a challenge to anesthesiologists in positioning the patients for spinal anesthesia. It is often difficult because of excruciating pain. This also presents difficulty in administration of spinal anesthesia because of inappropriate position of the patient.

Hence, there is a need to provide good pain relief to such patients in order to facilitate appropriate positioning for spinal anesthesia. This also provides comfort to the patient and reduces stress response because of pain relief.

Advantages of fascia iliaca compartment block (FICB) are that, it is inexpensive and can be easily administered using anatomical landmarks to provide perioperative analgesia in patients with fracture femur. Local anesthetic agent like bupivacaine has been introduced as it is potent and long acting which offers prolonged anesthesia with post-operative analgesia. Dexmedetomidine has been added as an adjuvant to local anesthetic agent in various blocks to increase the efficacy.

Therefore, ultrasound guided FICB is administered as it has better accuracy compared to landmark technique. FICB is administered with Bupivacaine and Dexmedetomidine. VAS and NRS scores are noted before FICB and during positioning the patient for spinal anaesthesia.

 
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