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CTRI Number  CTRI/2024/09/074454 [Registered on: 26/09/2024] Trial Registered Prospectively
Last Modified On: 17/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study
Modification(s)  
Comparing three Types of Pain Relief Techniques After Hip Replacement Surgery Done with Spinal Anesthesia 
Scientific Title of Study   Comparison between 3 inter-fascial plane blocks on the postoperative analgesia in patients undergoing hip arthroplasty under spinal anesthesia  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Diwan  
Designation  Senior Consultant  
Affiliation  Sancheti Institute of Orthopedics and Tehabiliation 
Address  operation theatre complex, Second floor, Department of Anesthesiology, Sancheti Hospital Pune MAHARASHTRA 411005 India

Pune
MAHARASHTRA
411005
India 
Phone  8484914584  
Fax    
Email  sdiwan1965@gmx.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandeep Diwan  
Designation  Senior Consultant  
Affiliation  Sancheti Institute of Orthopedics and Tehabiliation 
Address  operation theatre complex, Second floor, Department of Anesthesiology, Sancheti Hospital Pune MAHARASHTRA 411005 India

Pune
MAHARASHTRA
411005
India 
Phone  8484914584  
Fax    
Email  sdiwan1965@gmx.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sandeep Diwan  
Designation  Senior Consultant  
Affiliation  Sancheti Institute of Orthopedics and Tehabiliation 
Address  operation theatre complex, Second floor, Department of Anesthesiology, Sancheti Hospital Pune MAHARASHTRA 411005 India

Pune
MAHARASHTRA
411005
India 
Phone  8484914584  
Fax    
Email  sdiwan1965@gmx.com  
 
Source of Monetary or Material Support  
Sancheti Hospital 11/12 Thube Park, 16, Shivajinagar, Pune – 411005 Maharashtra, India 
 
Primary Sponsor  
Name  Sancheti Hospital  
Address  11/12 Thube Park, 16, Shivajinagar, Pune – 411005 Maharashtra, India 
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 
Dr Sandeep Diwan   Sancheti Institute of Orthopedics and Rehabiliation  Department of Anesthesiology, Operation theater, Second floor, Sancheti Hospital 11/12 Thube Park, 16, Shivajinagar, Pune – 411005 Maharashtra, India Pune MAHARASHTRA Pune MAHARASHTRA
Pune
MAHARASHTRA 
8484914584

sdiwan1965@gmx.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: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Erector Spinae Plane Block  An injection of local anesthetic into the plane deep to the erector spinae muscle, targeting nerves that can provide analgesia to the hip after spinal anesthesia 
Intervention  Fascia iliaca block   An injection of local anesthetic near the fascia iliaca to block the femoral nerve and other nerves supplying the hip region after spinal anesthesia.  
Comparator Agent  Quadratus lumborum block  An injection of local anesthetic near the quadratus lumborum muscle to block nerves that supply sensation to the hip area after spinal anesthesia.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adults of either gender aged between age between 18- and 80-years undergoing Hip arthroplasty under spinal anesthesia
American Society of Anesthesiologists (ASA) physical status I to III
 
 
ExclusionCriteria 
Details  Patients with coagulopathy, sepsis, hepatic or renal failure
allergy to local anesthetic (LA)
Patients with history of prior arthroplasty of the inguinal or suprainguinal area, pregnancy
Patients having opioids previously
Inability to consent to the study
Patients with pre-existing neuropathies
Patients with local infection around the needle site
Revision Arthroplasty
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to first rescue opioid in postoperative period  first 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Post-operative pain scores, total 24-hour opioid requirements, opioid-related side effects & duration of stay among two groups

 
pain scores at 0 2 4 8 & 24 hours
total morphine consumption after 24 hours
side effcets at 0 2 4 8 & 24 hours
time to discharge after surgery once  
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   10/10/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Total hip arthroplasty (THA) is a common surgical procedure that improves the health-related quality of life and functional status of patients. However, it is often associated with significant postoperative pain. This pain may decrease mobility, increase the risk of venous thromboembolism, impair rehabilitation, and delay recovery.  Therefore, adequate postoperative pain analgesia after THA is essential.

Regional anesthesia (RA) helps us to provide good pain management and recovery in hip arthroplasty. Central neuraxial blocks and general anesthesia have been the primary methods for anesthesia during hip arthroplasty. We have a wide range of peripheral nerve blocks (PNB) that have been seen with better outcomes in hip arthroplasty and significantly reduced complications in most outcome categories, such as cardiac, pulmonary, respiratory failure, and cognitive dysfunction complications.3 Newer approaches, such as quadratus lumborum block (QLB), suprainguinal fascia iliaca block (SIFIB), pericapsular nerve group (PENG) block and lumbar erector spinae block (ESPB) have also been described recently. Peripheral nerve blocks (PNBs) block the lumbar or sciatic nerve plexus after they exit the spinal column. The lumbar plexus innervates the skin dermatomes and femoral component for hip procedure, while the sciatic nerve plexus covers the acetabular innervation. These more distal approaches result in unilateral or no blockade of the sympathetic chain, resulting in lesser hemodynamic instability, neurological complications, or motor blockade post-arthroplasty.

US-guided SIFIB has been used as a reliable analgesic option for hip arthroplasty. SIFIB may lead to decreased motor strength of the surgical limb, thereby hindering postoperative mobilization and delaying discharge after outpatient hip Arthroplasty.

PENG selectively targets the articular branches of the femoral and accessory obturator nerves while sparing their motor components. The PENG block  is an easy regional technique to perform in the supine position with motor-sparing benefits. QLB has also been shown to provide good postoperative analgesia after hip arthroplasty. Lumbar erector spinae plane block (ESP) block is an upcoming anaesthetic modality for hip surgeries. It is a relatively safe technique, easy to perform, and associated with a lower risk of damage to surrounding nerves and vessels due to the USG based bony landmarks for the procedure and inadvertent intravascular injection. It can be given safely in anticoagulated patients or when spinal epidural is contraindicated. The large volume of local anesthetic deposited in the interfacial plane spreads to the lumbar plexus, along with spread to the L4-L5 nerve roots, blocking the sacral plexus as well.  Both continuous and single-shot lumbar ESP blocks have been proven to be promising analgesic alternatives in studies for reducing opioid consumption and ensuring early ambulation after hip surgeries.

Utilizing regional anesthesia helps to limit the use of opioids. However, which technique is best has yet to be determined.

In this randomized trial, we will compare four inter-fascial plane blocks, i.e., PENG, SIFI, QL3 and Lumbar ESP on the postoperative analgesia in patients undergoing hip arthroplasty under spinal anesthesia.

 
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