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CTRI Number  CTRI/2024/11/076544 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 08/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison between hip nerve block and groin nerve block for perioperative pain control in patients undergoing hip replacement surgery 
Scientific Title of Study   Comparison between pericapsular nerve group block and suprainguinal fascia iliaca block for perioperative pain control in hip arthroplasty: A randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANNU JOSE 
Designation  ASSISTANT PROFESSOR 
Affiliation  AL AZHAR MEDICAL COLLEGE  
Address  ROOM NO 10 DIVISION 6 DEPARTMENT OF ANAESTHESIOLOGY AL AZHAR MEDICAL COLLEGE EZHALLOOR PO THODUPUZHA IDUKKI KERALA INDIA

Idukki
KERALA
685605
India 
Phone  9074775410  
Fax    
Email  annulizbethjose@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ANNU JOSE 
Designation  ASSISTANT PROFESSOR 
Affiliation  AL AZHAR MEDICAL COLLEGE  
Address  ROOM NO 10 DIVISION 6 DEPARTMENT OF ANAESTHESIOLOGY AL AZHAR MEDICAL COLLEGE EZHALLOOR PO THODUPUZHA IDUKKI KERALA INDIA

Idukki
KERALA
685605
India 
Phone  9074775410  
Fax    
Email  annulizbethjose@gmail.com  
 
Details of Contact Person
Public Query
 
Name  ANNU JOSE 
Designation  ASSISTANT PROFESSOR 
Affiliation  AL AZHAR MEDICAL COLLEGE  
Address  ROOM NO 10 DIVISION 6 DEPARTMENT OF ANAESTHESIOLOGY AL AZHAR MEDICAL COLLEGE EZHALLOOR PO THODUPUZHA IDUKKI KERALA INDIA

Idukki
KERALA
685605
India 
Phone  9074775410  
Fax    
Email  annulizbethjose@gmail.com  
 
Source of Monetary or Material Support  
AL AZHAR MEDICAL COLLEGE EZHALLOOR PO PIN 685605 THODUPUZHA IDUKKI KERALA INDIA 
 
Primary Sponsor  
Name  AL AZHAR MEDICAL COLLEGE  
Address  AL AZHAR MEDICAL COLLEGE EZHALLOOR PO PIN 685605 THODUPUZHA IDUKKI KERALA INDIA 
Type of Sponsor  Private 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 ANNU JOSE  AL AZHAR MEDICAL COLLEGE MAIN OPERATION THEATRE  ROOM NO 10 DIVISION 6 DEPARTMENT OF ANAESTHESIOLOGY EZHALLOOR PO 685605 THODUPUZHA IDUKKI KERALA INDIA
Idukki
KERALA 
9074775410

annulizbethjose@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee,Al Azhar Medical College,Ezhalloor  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M16||Osteoarthritis of hip,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pericapsular nerve group block  USguided nerve block technique using 30 ml 0.2 % ropivacaine with 4mg dexamethasone. DURATION OF PROCEDURE-20 MINUTES DURATION OF BLOCK ACTION-24 HOURS 
Comparator Agent  Suprainguinal fascia iliaca block  USguided nerve block technique using 30 ml 0.2 % ropivacaine with 4mg dexamethasone. DURATION OF PROCEDURE-20 MINUTES DURATION OF BLOCK ACTION-24 HOURS 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.ASA physical status 1-3 patients
2.Age 25-80yrs
3.Scheduled for primary hip arthroplasty under spinal anaesthesia
 
 
ExclusionCriteria 
Details  1.Surgeries under GA
2.Patients who refused to give consent
3.Those with focal neurological deficit
4.History of allergy to local anaesthetic
5.Infection at the puncture site
6.Unable to understand NRS
• Coagulopathy/sepsis/hepatic or renal failure
• prior surgery of the inguinal or suprainguinal area
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
.post block NRS at rest and on passive 15° limb lifting
.Ease of spinal positioning
.postoperative morphine requirement 
30 minutes after the block 
 
Secondary Outcome  
Outcome  TimePoints 
. NRS over 24 hours
.amount of morphine used (number of rescue doses)
. degree of quadriceps weakness.  
24 hours postoperative period 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   01/12/2024 
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="0"
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  

Pain associated with hip surgery -a significant problem-Complications, morbidities, and low levels of patient satisfaction.Two blocks that have recently become popular for hip analgesia include pericapsular nerve group (PENG) block and SIFI block.There is paucity in literature regarding these blocks and to which one is more efficacious.

We hypothesised that SIFI block would provide better analgesia without significant quadriceps muscle weakness when compared with the PENG block following THA.

The study will be carried out in accordance with the ethical principles of the Declaration of Helsinki, 2013. Its procedure will be explained to each patient, and a written and informed consent will be taken for participation in this study and for the use of the patient data for educational and research purposes. The consultant doing the pre-anaesthetic check-up will carry out a consecutive sampling of all eligible participants and enroll them into the study. Randomisation will be done by an independent statistician using software for block randomisation techniques of varying block sizes (3–5). Allocation concealment will be done using serially numbered, opaque, sealed envelopes (SNOSE technique). The sealed envelope will be opened by a consultant who is not part of the study once the patient  reaches the pre-medication room, thus assigning the participant to the intervention. This assigned consultant then performs the block in the block room. All observations will be done in the operating room and PACU  by the investigator  who is unaware of the regional block performed.  All the participants will remain blinded to the block administered.

NRS score will be explained to the patients at the time of pre-operative assessment.Pre-procedure pain will be  assessed during rest as well as on movement (15° passive elevation) of the affected limb and recorded on numeric pain rating scale (NRS) [0 = no pain; 10 = worst imaginable pain].

The blocks will be performed in supine position following sterile techniques. Both the blocks will be performed as per the standard USguided techniques using 30 ml 0.2 % ropivacaine with 4mg dexamethasone.

After the block, patient  will be shifted to the operating room and will be continuously monitored with non-invasive blood pressure every 5 minutes, continuous ECG and pulse oximetry and for signs of local anaesthetic toxicity for 30 minutes. Thirty minutes after the blocks, analgesia will be measured by NRS at rest and on passive limb elevation. If any patient had NRS >5, intravenous (IV) fentanyl 20 µg will be given every 5 minutes till NRS score becomes 3, and then, they will be allowed for sitting position for SA.NRS score will be explained to the patients at the time of pre-operative assessment.Pre-procedure pain will be  assessed during rest as well as on movement (15° passive elevation) of the affected limb and recorded on numeric pain rating scale (NRS) [0 = no pain; 10 = worst imaginable pain].

The blocks will be performed in supine position following sterile techniques. Both the blocks will be performed as per the standard USguided techniques using 30 ml 0.2 % ropivacaine with 4mg dexamethasone.

After the block, patient  will be shifted to the operating room and will be continuously monitored with non-invasive blood pressure every 5 minutes, continuous ECG and pulse oximetry and for signs of local anaesthetic toxicity for 30 minutes. Thirty minutes after the blocks, analgesia will be measured by NRS at rest and on passive limb elevation. If any patient had NRS >5, intravenous (IV) fentanyl 20 µg will be given every 5 minutes till NRS score becomes 3, and then, they will be allowed for sitting position for SA.

The amount of fentanyl used, NRS scores and scores for EOSP will be recorded.

All observations will be done by another anaesthesiologist who is unaware of the regional block performed. All patients will receive spinal anesthesia with 10mg of hyperbaric bupivacaine (ie, 2mL of bupivacaine 0.5%) and 20µg of fentanyl.All interventions will be performed by the same team of surgeons using a posterior approach and a lateral decubitus position.

Postoperative analgesia will be  provided with IV paracetamol 1 gm every 8 h. The rescue analgesia will be provided with 1 mg morphine on demand or when NRS is >4.All patients will be followed up postoperatively at 2,4, 6, 8, 12 and 24 hours.

 
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