| 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
|
|
|
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
|
|
|
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.
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