FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/080529 [Registered on: 13/02/2025] Trial Registered Prospectively
Last Modified On: 10/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing three blocks given in femur fractures PENG block, FICB and FNBB under ultrasound guidance with 0 75% Ropivacaine drug 
Scientific Title of Study   Comparison of analgesic efficacy among pericapsular nerve group block(PENG) fascia iliaca compartment block (FICB) and femoral nerve block (FNB) for positioning during subarachnoid block in proximal femur fractures - a hospital based 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  DR AMITA MALLANNA HIPPARAGI 
Designation  POST GRADUATE 
Affiliation   
Address  DEPARTMENT OF ANAESTHESIOLOGY KLE UNIVERSITY JNMC NEHRU NAGAR BELGAUM

Belgaum
KARNATAKA
590010
India 
Phone  7406072136  
Fax    
Email  amitham8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR MAHANTESH MUDAKANGOUDAR 
Designation  PROFESSOR 
Affiliation  JNMC BELGAUM KLE UNIVERSITY 
Address  DEPARTMENT OF ANAESTHESIOLOGY KLE UNIVERSITY JNMC NEHRU NAGAR BELGAUM

Belgaum
KARNATAKA
590010
India 
Phone  7829164500  
Fax    
Email  drmontygoudar@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DR AMITA MALLANNA HIPPARAGI 
Designation  POST GRADUATE 
Affiliation  JNMC BELGAUM KLE UNIVERSITY 
Address  DEPARTMENT OF ANAESTHESIOLOGY KLE UNIVERSITY JNMC NEHRU NAGAR BELGAUM

Belgaum
KARNATAKA
590010
India 
Phone  7406072136  
Fax    
Email  amitham8@gmail.com  
 
Source of Monetary or Material Support  
JAWAHARLAL NEHRU MEDICAL COLLEGE HOSPITAL BELGAUM 
 
Primary Sponsor  
Name  AMITA MALLANNA HIPPARAGI 
Address  DEPARTMENT OF ANAESTHESIOLOGY KLE UNIVERSITY JNMC NEHRU NAGAR BELGAUM 
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 AMITA MALLANNA HIPPARAGI  JAWAHARLAL NEHRU MEDICAL COLLEGE AND HOSPITAL  KLES PRABHKAR KORE HOSPITAL JNMC NEHRU NAGAR BELGAUM
Belgaum
KARNATAKA 
7406072136

amitham8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M97-M97||Periprosthetic fracture around internal prosthetic joint, (2) ICD-10 Condition: M97-M97||Periprosthetic fracture around internal prosthetic joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  FNB  FNB UNDER USG GUIDANCE FEMORAL NERVE IS IDENTIFIED A 22 GAUGE NEEDLE IS INSERTED USING HYDRODISSECTION TECHNIQUE 15ML OF 0 75 PERCENT ROPIVACAINE IS INJECTED 
Intervention  FICB  FICB UNDER USG GUIDANCE A 22 GAUGE NEEDLE INTRODUCED TO THE INGUINAL LIGAMENT TO PLACE NEEDLE TIP BETWEEN INTERNAL OBLIQUE AND ILIACUS MUSCLES USING HYDRODISSECTION TECHNIQUE 15ML OF 0 75 PERCENT ROPIVACAINE IS INJECTED 
Comparator Agent  PENG BLOCK  PENG BLOCK UNDER USG GUIDANCE A 22 GAUGE NEEDLE IS INSERTED IN AN IN PLANE APPROACH TO PLACE THE TIP BETWEEN PUBIC RAMUS POSTERIOR AND PSOAS TENDON ANTERIOR USING HYDRODISSECTION TECHNIQUE 15ML OF 0 75 PERCENT ROPIVACAINE IS INJECTED 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  AGE 18 YEARS AND ABOVE
PATIENTS UNDERGOING FEMUR FRACTURE SURGERIES UNDER SPINAL ANAESTHESIA
EITHER SEX
PATIENTS WILLING TO GIVE CONSENT 
 
ExclusionCriteria 
Details  HYPERSENSITIVITY TO LOCAL ANAESTHESIA
PRE EXISTING RESPIRATORY CARDIOVASCULAR NEUROLOGICAL RENAL DISORDERS
ALCOHOL OR DRUG ABUSE 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
PAIN ASSESSMENT BEFORE AND AFTER GIVING THE PENG FICB AND FNB FOR POSITIONING DURING SUBARACHNOID BLOCK IN PROXIMAL FEMUR FRACTURES  HEMODYNAMIC MONITORING FOR 30 MINUTES AFTER GIVING THE BLOCK 
 
Secondary Outcome  
Outcome  TimePoints 
HEMODYNAMIC MONITORING  HEMODYNAMIC MONITORING FOR 30 MINUTES AFTER GIVING THE BLOCK 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   25/02/2025 
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="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  
Hip and neck of femur fractures are the most commonly occurring serious injuries in older people where the need for emergency anaesthesia and surgery increases and account for the most common cause of death following accident. Upto 50-70% of patients record severe to very severe pain on pain scoring in the first 24 hours following hip fractures.
Severe pain encountered during positioning for spinal anaesthesia can worsen the patient experience psychologically and physically . Regional blocks facilitate patient positioning for spinal anaesthesia like the Fascia Iliaca Compartment Block, Pericapsular Nerve Group Block for efficacious pain control.

Primary Objective : Assessment of pain after PENG Block or FICB or FNB at the time of positioning for spinal anaesthesia in proximal femur fractures.

Inclusion Criteria : Age 18 years and above.
                                   Patients undergoing fixation of femur fractures surgeries under spinal anaesthesia.
                                   Either sex.
                                   Patients willing to give consent.

Exclusion Criteria : Hypersensitivity to local anaesthesia.
                                   Pre-existing respiratory, cardiovascular, neurological, renal disorders.
                                   Alcohol or drug abuse.
                                   Patients who do not fulfil inclusion criteria.

Study Protocol :
After obtaining the approval of ethical committee and written informed consent, a total of 90 patients (30 in each group) undergoing surgery under regional anaesthesia will be included in the study. Patients will be randomised  based on computer generated randomization table into one of the three groups.
After confirming NBM status prior to the block pain score assessed by visual analogue scale and vitals monitored, block is given 30 minutes before the surgery.

Group P : Will be receiving PENG Block with 15ml of 0.75% Ropivacaine. A curvilinear low frequency ultrasound probe is placed over the line parallel to the inguinal ligament , rotated 45 degree to identify the anterior inferior iliac spine, the iliopubic eminence and psoas tendon. A 22 gauge needle is inserted in an in-plane approach to place the tip between pubic ramus posterior and psoas tendon anterior using hydrodissection technique.  Following negative aspiration a total volume of 15ml of ropivacaine (0.75%) injected.

Group F : Will be receiving FICB with 15ml of 0.75% Ropivacaine. A linear ultrasound probe placed over the inguinal ligament in saggital plane, inferior medially to anterior superior iliac spine. Identify the bow tie sign formed by sartorius and the internal oblique muscle by sliding medially and rotating probe.  A 22 gauge needle introduced 1cm cephalad to the inguinal ligament to place the needle tip in the space between the internal oblique and iliacus muscles using hydrodissection technique. A total volume of 15ml of ropivacaine (0.75%) injected after negative aspiration.

Group FN : Will be receiving FNB with 15ml of 0.75% Ropivacaine. A linear ultrasound probe placed over femoral crease moved in lateral- medial direction to identify the artery. A 22 gauge needle introduced in an in-plane technique to nerve block the femoral nerve at the femoral crease. A total volume of 15ml of ropivacaine (0.75%) injected after negative aspiration.

Pain scores will be assessed after 30 minutes of giving the block to the patient using visual analogue scale before spinal anaesthesia.
 

 
Close