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CTRI Number  CTRI/2024/09/074031 [Registered on: 19/09/2024] Trial Registered Prospectively
Last Modified On: 18/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing pain experienced while sitting for spinal anesthesia and postoperative analgesia in suprainguinal and infrainguinal approaches for Fascia Iliaca Compartment block using an ultrasound machine in patients undergoing elective femoral fracture surgery. 
Scientific Title of Study   Ultrasound guided Fascia Iliaca Compartment block comparing suprainguinal and infrainguinal approaches: A prospective randomized 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  Rishabh Srivastava 
Designation  First year post graduate student 
Affiliation  Navodaya Medical College, Hospital And Research Centre 
Address  Department of Anesthesiology Navodaya Medical College, Hospital And Research Centre Raichur- 584103 Karnataka

Raichur
KARNATAKA
584103
India 
Phone  7829923325  
Fax    
Email  RISHABH3103@GMAIL.COM  
 
Details of Contact Person
Scientific Query
 
Name  Vishwanath 
Designation  Associate Professor 
Affiliation  Navodaya Medical College, Hospital And Research Centre 
Address  Department of Anesthesiology Navodaya Medical College, Hospital And Research Centre Raichur- 584103 Karnataka

Raichur
KARNATAKA
584103
India 
Phone  9886777750  
Fax    
Email  VISHWANATH.METI@GMAIL.COM  
 
Details of Contact Person
Public Query
 
Name  Vishwanath 
Designation  Associate Professor 
Affiliation  Navodaya Medical College, Hospital And Research Centre 
Address  Department of Anesthesiology Navodaya Medical College, Hospital And Research Centre Raichur- 584103 Karnataka

Raichur
KARNATAKA
584103
India 
Phone  9886777750  
Fax    
Email  VISHWANATH.METI@GMAIL.COM  
 
Source of Monetary or Material Support  
Navodaya Medical College, Hospital And Research Centre Raichur- 584103 
 
Primary Sponsor  
Name  Dr Rishabh Srivastava 
Address  Department of Anesthesiology Navodaya Medical College, Hospital And Research Centre Raichur- 584103 Karnataka 
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 Rishabh Srivastava  Navodaya Medical College, Hospital And Research Centre  Operation Theatre Department of Anesthesiology Navodaya Medical College, Hospital And Research Centre Raichur- 584103
Raichur
KARNATAKA 
7829923325

RISHABH3103@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICS COMMITTEE (IHEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S729||Unspecified fracture of femur,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Infrainguinal Fascia Iliaca Compartment block  Infrainguinal Fascia Iliaca Compartment block with 30 ml 0.2% Ropivacaine will be given under USG guidance. 
Intervention  Suprainguinal Fascia Iliaca Compartment block  Suprainguinal Fascia Iliaca Compartment block with 30 ml of 0.2% Ropivacaine will be given under USG guidance. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1) Age- 18 to 80 years of either gender.
2) Patients belonging to ASA Physical Status I and II.
3) Patients undergoing elective femoral fracture surgery. 
 
ExclusionCriteria 
Details  1) Patients refusal for the procedure.
2) Patients with history of allergy, sensitivity or any kind of reactions to local anaesthetic agents.
3) Patients with bleeding disorders or any significant coagulopathies and other contraindications for regional anesthesia.
4) Infection of the skin at the injection site.
5) Any lesion obscuring sonoanatomy.
6) Patients with pre-existing significant systemic diseases.
7) Patients on anticoagulants.
8) Patients with psychiatric illness.
9) Patients receiving combined spinal-epidural for lower limb surgeries
10) Inability to comprehend NRS scale. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Pain experienced while sitting for spinal anesthesia
2) Postoperative analgesia 
Postoperative analgesia- Pain will be assessed using pain score: Numerical Rating Scale at 2nd, 4th, 6th, 8th, 10th, 12th, 14th, 16th, 18th, 20th, 22nd and 24th hour postoperatively. 
 
Secondary Outcome  
Outcome  TimePoints 
Visualization of needle (whole length/ partial length)  This will be noted while giving block. 
Anatomical visualization of structures (good/poor)  This will be noted while giving block. 
Duration taken to give block  This will be noted while giving block. 
Area of drug spread achieved  This will be assessed immediately after giving block. 
Duration of sensory block  The sensory affect will be assessed immediately after giving block & noting the onset time, which is time for the end of the injection to dull response to pin prick, & noting the peak time, which is time for the end of the injection to no response to pin prick. 
Time to rescue analgesia  This will be assessed in the postoperative period. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   30/09/2024 
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="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   After obtaining institutional ethical committee approval, written and informed consent will be taken from the patient.
The study will be conducted in 100 patients between 18 to 80 years of age, ASAI and ASA-II of either gender undergoing femur fracture surgeries under subarachanoid block.
Patients will be randomly allocated into one of the following groups of 50 patients each using a computer-generated random number table:

Group S – USG guided Suprainguinal FICB with 30 mL 0.2% ropivacaine 
Group I – USG guided Infrainguinal FICB with 30 mL 0.2%

All the patients in the study will be subjected to a thorough pre-anaesthetic evaluation which includes a detailed history taking, complete general physical examination, systemic examination, and necessary relevant investigations like complete blood count, blood urea, serum creatinine, chest X-ray, ECG, bleeding time, clotting time, random blood sugar, and urine analysis (Sugar, Albumin, and Microscopy).
All patients will be kept nil per oral according to standard guidelines. Tablet Alprazolam 0.5 mg and Tablet Pantoprazole 40 mg will be given the day before surgery. Additionally, at 6 AM on the day of surgery, Injection Pantoprazole 40 mg will be adminstered intravenously. A suitable intravenous line will be secured for the administration of fluids and drugs.
Preoperatively, the Numerical Rating Scale will be explained to the patient, and the intensity of pain will be evaluated on a scale of 0 to 10. A score of 0 indicates no pain, while a score of 10 indicates worst pain imaginable.
The patient will be shifted to pre-operative room and multiparameter monitor will be connected and pre-operative heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, respiratory rate, oxygen saturation, ECG will be recorded and intravenous fluids will be connected.
All patients will undergo either the suprainguinal or infrainguinal approach in the Fascia Iliaca Compartment block, based on their assigned group. The procedure will be conducted by an experienced anesthesiologist. Needle visualization, anatomical visualization of structures, duration taken to give block, area of drug spread will be noted and a blinded observer will assess postoperative pain scores and 24-hour tramadol injection consumption.
The patient will be positioned in the supine position, and the area over the inguinal crease will be prepared using aseptic techniques, followed by disinfection with povidone iodine. Ultrasound-guided fascia iliaca compartment block will be performed on patients according to their assigned groups.For patients in Group S, the fascia iliaca compartment block will be performed using an ultrasound-guided suprainguinal approach. A high-frequency (6–14 MHz) linear probe of GE LOGIC C5 PREMIUM USG machine will be used to locate the femoral artery in the short axis by palpating the anterior superior iliac spine (ASIS). The sartorius muscle will then be identified and traced cephalad to its insertion on the ASIS. The ultrasound probe will be positioned to visualize the iliacus muscle, and a 20G x 1, ½” inch hypodermic needle will be advanced in-plane to puncture the fascia iliaca. Confirmation of needle tip location will be achieved by injecting 2 mL of local anesthetic, followed by incremental injection of 30 mL of 0.2% ropivacaine superficial to the iliacus muscle and deep to the fascia iliaca. The spreading of the local anesthetic will be confirmed by observing caudomedial spreading toward the femoral nerve.
For the infrainguinal approach, the patient will remain in the supine position, and a high-frequency (6–14 MHz) linear probe will be used to locate the femoral artery transversely at the inguinal crease. The femoral nerve and fascia iliaca will be identified, and a blunt-ended needle will be inserted using an in-plane technique beneath the fascia iliaca around the lateral third of a line between the ASIS and pubic tubercle. Confirmation of needle placement will be followed by incremental injection of 30 mL of 0.2% ropivacaine. Placement will be confirmed by observing the separation of the fascia iliaca from the iliopsoas muscle and the spreading of local anesthetic toward the femoral nerve medially and iliac crest laterally.
The sensory block will be defined as time from the end of injection to dull response to pin prick, and peak sensory effect was defined as time from the end of injection to no response of pin prick.

PAIN SCORE : NRS (Numerical Rating Scale)

Patients will be asked to select a number between 0 and 10 that best represents their pain intensity. 
When the NRS score reaches < 4, the patient will be shifted to the operating theatre, where a multiparameter monitor will be connected. The patient will then be positioned in a sitting position for spinal anesthesia. If any patient reports pain with a score greater than 4 during positioning, they will be excluded from the study, as it may indicate a potential failure of the nerve block.
Under all aseptic precautions, spinal anaesthesia will be given in L3-L4 space using appropriate Quincke Babcock’s spinal needle. After clear CSF flow, 3 ml of Inj. Bupivacaine heavy 0.5% will be administered, and patient’s vitals will be monitored.
Any side effects and complications will be noted and treated. If SBP falls below 20% of baseline or reaches 90 mmHg , it is treated with IV fluids and Inj.Mephentramine 6mg/I.V. if pulse rate reaches less than 60 beats per minute, Inj. Glycopyrrolate 0.2 mg/I.V will be given. After the completion of surgery, the patient will be transferred to the recovery room and monitored every hour until the NRS score exceeds 4. When the NRS score is greater than or equal to 4, rescue analgesia with Inj. Tramadol 100 mg in 100 ml normal saline will be administered.
After the completion of surgery, the patient will be transferred to the recovery room and monitored every hour until the NRS score exceeds 4. When the NRS score is greater than or equal to 4, rescue analgesia with Inj. Tramadol 100 mg in 100 ml normal saline will be administered.
Duration of analgesia: Time taken from completion of FICB to when NRS score reaches more than or equal to 4. 
The presence of any side effects such as bradycardia, hypotension, tachycardia, nausea, vomiting, hematoma, infections, and post-block neuropathy will be noted. 
Statistics:
Statistical test: The collected data from questionnaire will be coded and manually entered into the computer for statistical analysis.
Statistical analysis will be done by using: 1) Unpaired t-test: It is used for test for Significance. If P value < 0.05 will be considered for statistically significant @ 95% level of significance. 2) Inferential Statistics: Percentages, means, Standard deviation will be calculated. Results will be expressed in the form of graphs and tables.
 
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