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CTRI Number  CTRI/2025/02/080817 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 12/02/2025
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   Comparison of pain relief due to two different injections in combination with an injection around hip bone in patinets with hip fractures 
Scientific Title of Study   A comparative study on the efficacy of PENG block with either supra-inguinal fascia iliaca block or circum-psoas block for postoperative analgesia in elderly patients undergoing surgery for proximal hip fractures 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sandeep Madhusudan Diwan 
Designation  Consultant Anesthesiologist 
Affiliation  Sancheti Hospital, Pune 
Address  Department of Anesthesiology, Sancheti Hospital, Pune

Pune
MAHARASHTRA
411005
India 
Phone  8484914584  
Fax    
Email  sdiwan14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sandeep Madhusudan Diwan 
Designation  Consultant Anesthesiologist 
Affiliation  Sancheti Hospital, Pune 
Address  Department of Anesthesiology, Sancheti Hospital, Pune
Department of Anesthesiology, Sancheti Hospital
Pune
MAHARASHTRA
411005
India 
Phone  8484914584  
Fax    
Email  sdiwan14@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sandeep Madhusudan Diwan 
Designation  Consultant Anesthesiologist 
Affiliation  Sancheti Hospital, Pune 
Address  Department of Anesthesiology, Sancheti Hospital, Pune


MAHARASHTRA
411005
India 
Phone  8484914584  
Fax    
Email  sdiwan14@gmail.com  
 
Source of Monetary or Material Support  
Sancheti Hospital, Pune 
 
Primary Sponsor  
Name  Sancheti Hospital 
Address  16, Shivajinagar, Pune, Maharashtra 411005 
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 Hospital  Department of Anaesthesia, 16, Shivajinagar
Pune
MAHARASHTRA 
8484914584

sdiwan14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-SIOR  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  Circumpsoas block is the comparator  Under due asepsis, a linear array high-frequency ultrasound (US) probe with 13-6 MhZ (Fujifilm Sonosite Inc, USA) will be deployed below the inguinal ligament and the psoas tendon, iliacus muscle and fascia, femoral nerve, and femoral artery will be identified in a transverse scan.  
Intervention  Supra-inguinal fascia iliaca block is the intervention performed  Intraoperative S-FICB will be performed by means of the suprainguinal technique after detection of the bow-tie sign formed by the internal oblique and sartorius muscles. A total of 30 mL of 0.2% ropivacaine with clonidine 15mcg will be injected under the abdominal muscle to maintain the spread using an in-plane technique. 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  proximal femur fracture surgery (intertrochanteric, neck of femur and subtrochanteric fractures) and consenting for the trial  
 
ExclusionCriteria 
Details  inability or refusal to sign informed consent, younger than 18 years, BMI greater than 35 kg/m2, intolerance to any of the drugs used in the study, a history of hepatic or renal insufficiency, coagulopathy, using chronic analgesic drugs; having additional illnesses, including liver or kidney diseases, neurological deficits in the lower extremities and illnesses that interfered with communication skills such as dementia or mechanical ventilation requirement. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
24-hrs opioid consumption  24-hrs 
 
Secondary Outcome  
Outcome  TimePoints 
1. Time to the first analgesia
2. Resting NRS scores at 0, 2, 8, 12, 24 hrs
3. Dynamic NRS scores at 0,2,8,12,24 hrs
4. Number of patients with NRS 0 at 6hrs.
5. Adverse effects in the 2 groups
 
0,2,8,12,24 hours 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 3 
Date of First Enrollment (India)   01/04/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

The fascia iliaca block is a commonly used compartment block for cutaneous analgesia for hip surgery. The hip joint is innervated by branches of the femoral nerve (FN), obturator nerve (ON), and sciatic nerve (SN). The lateral femoral cutaneous nerve (LFCN) should also be blocked if the surgical incision extends to the lateral side of the thigh. The FN, ON, and LFCN are all part of the lumbar plexus, implying that blocking the lumbar plexus is an elegant way to provide postoperative analgesia for THA. The fascia iliaca compartment block (FICB) can be regarded as an anterior approach of the lumbar plexus. This block anesthetizes the lateral femoral cutaneous nerve but has reported failure rates of 10% to 37%. Moreover, a recent study failed to demonstrate the benefit of a “classic” transverse FICB at the level of the FN for postoperative analgesia after hip arthroplasty. Supra-inguinal fascia iliaca (SIFI) block is a novel regional anaesthesia technique that was first described by Hebbard et al. in 2015 as an alternative technique to the classic infrainguinal fascia iliaca block on the presumption that it will provide a wider local anaesthetic spread and better coverage of the lateral femoral cutaneous nerve. The course of the lateral femoral cutaneous nerve below the inguinal ligament is variable as opposed to consistent above the inguinal ligament in the pelvis. The authors used a supra-inguinal ultrasound-guided technique and placed local anaesthetic directly into the iliac fossa and found that it leads to extensive fluid spread throughout the iliac fossa. They described consistent staining of the femoral nerve and lateral femoral cutaneous nerve in their cadaveric dye study. Subsequently, many clinical studies demonstrated its analgesic efficacy. One study comparing lumbar plexus block versus SIFI block for total hip arthroplasty found that SIFI block provided equivalent analgesic efficacy and longer duration of analgesia. 

Circumpsoas block (CPB) is a recently described block which is an anterior myofascial plane block for lumbar plexus elements. In an attempt to improvise the analgesia in patients with femoral fractures,  local anesthetic was deposited deep to anterior psoas fascia under ultrasound guidance to block lumbar plexus elements which emerge lateral, anterior, and medial to the psoas major muscle. . Clinical and computed tomography contrast studies revealed that a continuous CPB infusion with a catheter provided a reliable block of the lumbar plexus elements. No adverse were events noted. Hence, it is implied that US guided CPB is a reliable technique for managing postoperative pain after surgery of femur fractures. Since SIFI block does not provide coverage for obturator nerve, we hypothesized that PSB would provide a superior pain relief compared to SIFI block. At present, no study has compared these two regional anesthesia techniques. Hence, we decided to compare the two techniques for postoperative analgesic efficacy.

 
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