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CTRI Number  CTRI/2021/09/036787 [Registered on: 23/09/2021] Trial Registered Prospectively
Last Modified On: 24/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of two regional anesthesia techniques for adequate pain control after surgeries around hip joint 
Scientific Title of Study   Comparison of analgesic efficacy of supra-Inguinal fascia iliaca compartment block (S-FICB) and pericapsular nerve group (PENG) block in patients undergoing hip surgery: A prospective randomized controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sadik Mohammed 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Anaesthesiology and Critical Care, All India institute of medical sciences (AIIMS), HI Area Phase II, Basni.

Jodhpur
RAJASTHAN
342005
India 
Phone  9414849733  
Fax    
Email  drmsadik@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sadik Mohammed 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Anaesthesiology and Critical Care, All India institute of medical sciences (AIIMS), HI Area Phase II, Basni.


RAJASTHAN
342005
India 
Phone  9414849733  
Fax    
Email  drmsadik@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Subham Das 
Designation  PG Student 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology and Critical Care, All India institute of medical sciences (AIIMS), HI Area Phase II, Basni.

Jodhpur
RAJASTHAN
342005
India 
Phone  9531127885  
Fax    
Email  sdasqwert@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, Jodhpur 
 
Primary Sponsor  
Name  AIIMS Jodhpur 
Address  All India institute of medical sciences (AIIMS), HI Area Phase II, Basni, Jodhpur, Rajasthan 342005 
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 
Sadik Mohammed  AIIMS, Jodhpur  Department of Anaesthesiology and Critical Care, 3rd Floor, DnT Block, AIIMS, Phase II, Basani Industrial Area, Jodhpur.
Jodhpur
RAJASTHAN 
0291-2740741

drmsadik@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pericapsular Nerve Group Block  Ultrasound guided deposition of 20 mL bupivacaine 0.5% with epinephrine 5 mcg/mL between psoas tendon and pubic ramus.  
Comparator Agent  Supra-inguinal fascia ilica compartment block  Ultrasound guided deposition of 40 mL bupivacaine 0.5% with epinephrine 5 mcg/mL above iliacus muscle.  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Belonging to American Society of Anesthesiologists Physical Status 1-3 and Scheduled for elective unilateral total hip replacement surgery.
 
 
ExclusionCriteria 
Details  1. Known hypersensitivity to any of the drugs used in the study.
2. Patient having infection at the site of block.
3. Patients with coagulopathy or on anticoagulation therapy.
4. Patients with untreated psychiatric illness.
5. Patients with known cardiac, hepatic or kidney diseases.
6. Opioid Dependency
7. Pre-existing neurologic or anatomic deficits in the lower extremities
8. Prior surgery in the corresponding side of the inguinal or suprainguinal area
9. Chronic pain syndromes requiring opioid intake at home
10. Pregnancy 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Post-operative pain relief assessed by Numeric Rating Scale (NRS) at fixed time interval  First 24 postoperative hours 
 
Secondary Outcome  
Outcome  TimePoints 
1. Motor Blockade at fixed time interval
2. The time of first rescue analgesic requirement.
3. Total amount of analgesia consumed during 24-hours.
4. Duration to perform block.
5. Patient’s satisfaction for the mode of analgesia.
6. Periprocedural complication.
 
First 24 postoperative hours 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
Final Enrollment numbers achieved (Total)= "58"
Final Enrollment numbers achieved (India)="58" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/08/2023 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  On personal request through mail at drmsadik@gmail.com

  6. For how long will this data be available start date provided 07-04-2023 and end date provided 31-03-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Pre-anaesthetic evaluation will be done for all the patients, a day before surgery. All patients will be thoroughly explained about the procedure. They will also be made well conversant about the Numeric Rating Scale (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain). The standard instruction of fasting will be given to all patients (2 hours for clear liquids and 6 hours for semisolid and solid food).

On arrival of the patient in preoperative holding area, patient identification, fasting status, consent, and PAC will be confirmed. In the procedure room, standard ASA monitors like electrocardiogram (ECG), non-invasive blood pressure (NIBP) pulse oximetry will be attached and baseline vitals will be recorded. A peripheral intravenous cannula will be secured in ipsilateral upper limb and intravenous fluids will be started. All patients will receive combined spinal epidural (CSE). Epidural space will be identified using loss of resistance to saline subarachnoid block will be performed using needle through needle technique with bupivacaine 0.5% heavy 15 mg. Epidural catheter will be secured and a test dose (3 mL of lignocaine 1.5% with 5 mcg/mL epinephrine) will be administered through the catheter. Following CSE, one of the intervention techniques as per randomization will be performed.

Following the block patients will undergo the scheduled surgery. During the surgery vitals [heart rate (HR), mean arterial pressure (MAP), oxygen saturation (SpO2) and temperature] will be recorded. No further analgesics will be administered during the surgery. After completion of surgical procedure, patients will be shifted to PACU.

Postoperative analgesia will be assessed using NRS immediately after receiving the patient in the PACU and thereafter at 1-hour, 3-hours, 6-hours, 12-hours, 18-hours and at 24-hours. On recording of NRS ≥4 or on patient demand rescue analgesia (10 mL 0.2% ropivacaine) through epidural catheter will be administered and time to rescue analgesia will be recorded. Total epidural boluses during the observation period will also be recorded.

The motor blockade will be assessed at predefined time interval by testing the quadriceps motor function with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The patient will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).

Patient satisfaction will be recorded on a four-point Likert’s scale as 1- excellent; 2- good; 3- fair and 4- poor.

Block performance time defined as time interval between putting the ultrasound probe and completion of LA agent.

Periprocedural complication like vascular puncture, paresthesia, systemic LA toxicity etc will be recorded.

 
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