| CTRI Number |
CTRI/2024/07/071546 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Significance of tensor fascia Lata block in addition to Fascia Iliaca Compartment Block in pain relief for patients undergoing femur surgeries |
|
Scientific Title of Study
|
A Prospective randomized control trial to assess the role of Tensor Fascia Lata Plane Block in addition to Fascia Iliaca Compartment Block (FICB) using ultrasound in patient undergoing proximal femur surgeries through
lateral incision of thigh. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
John Arun Kumar J |
| Designation |
Junior Resident |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesiology,
Christian Medical College,Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
9566191876 |
| Fax |
|
| Email |
john46rockie@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul pillai |
| Designation |
professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesiology,
Christian Medical College,Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
9894460758 |
| Fax |
|
| Email |
Cmcrahulpillai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
John Arun Kumar J |
| Designation |
Junior Resident |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesiology,
Christian Medical College,Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
9566191876 |
| Fax |
|
| Email |
john46rockie@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fluid research Grant,
christian medical college,Vellore 632004 .Tamil nadu |
|
|
Primary Sponsor
|
| Name |
Christian Medical college vellore |
| Address |
Department of Anaesthesiology,
christian medical college vellore.632004 |
| Type of Sponsor |
Private medical college |
|
|
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 John Arun Kumar J |
Christian medical collge |
Department of Anaesthesiology,chrsitian medical college.vellore
Vellore
TAMIL NADU |
9566191876
john46rockie@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutuional Review Board and Ethics committee of CMC Vellore. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fascia Iliaca Compartment Block |
patient is randomised by double blinding technique before the procedure. They are randomised into two groups GROUP A (Fascia Iliaca Compartment Block) and GROUP B (Fascia Iliaca Compartment Block+ TFL Block).Under sterile aseptic precaution the anterior and lateral regions of the thigh at the inguinal region and upper thigh will be painted and draped .The ultrasound linear, high frequency transducer probe will be draped with sterile cover and first placed at inguinal region.fascia illiaca compartment is with a single shot of 8-10 ml of 0.25% bupivacaine or 0.2% ropivacaine with 0.2mcg/kg of dexmedetomidine will be administered after confirmation of drug spread. This procedure may take a time period of 10 minutes for administration of block.
|
| Comparator Agent |
Tensor fascia Lata block in addition to Fascia Iliaca Compartment Block |
patient is randomised by double blinding technique before the procedure. They are randomised into two groups GROUP A (Fascia Iliaca Compartment Block) and GROUP B (Fascia Iliaca Compartment Block+ TFL Block).Under sterile aseptic precaution the anterior and lateral regions of the thigh at the inguinal region and upper thigh will be painted and draped.The ultrasound linear, high frequency transducer probe will be draped with sterile cover and first placed at inguinal region.The femoral vessels, illiacus and sartorius muscle will be identified. The probe will then be moved laterally till the tensor fascia lata muscle appears into view after sartorius insertion. identifying the arterial pulsation at the lower border of the muscle ,the block needle will be inserted from the medial edge of the probe and advanced till the lower border of the TFL.Upon reaching this point, the probe is moved 0.5 – 1 cm cranially from the point of entry of the artery, and the drug will be injected after negative aspiration .The expected endpoints will be drug spread along tensor fascia lata and the gluteus Medius muscle.A single shot of 8-10 ml of 0.25% bupivacaine or 0.2% ropivacaine with 0.2mcg/kg of dexmedetomidine will be administered after confirmation of drug spread.This procedure will take time period of 10 minutes to administer the block.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
-patients between the ages of 18 and 80
-ASA I, II, III
-patients giving written and informed consent
|
|
| ExclusionCriteria |
| Details |
-patients unwilling to give consent
-any surgeries involving the hip joint
-patient with infection at the site of puncture
-patients with known allergy to local anesthetics
-patients without documented peripheral neuropathy
-Patients with Clinical Frailty Scale greater than IV
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess postoperative pain between the targeted nerve block groups – Conventional fascia iliaca block versus Fascia iliaca + TFL Block for first 48 hours |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Requirement of rescue analgesia for first 48 hours
- Good safety profile
|
48 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
10/08/2024 |
| 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
|
The current practice in regional anesthesia
for proximal femur surgeries with lateral incisions is the Fascia Iliaca
Compartment Block (FICB) and the Pericapsular Nerve Group (PENG) block. The
FICB is an anterior lumbar plexus block in which local anaesthetic is injected
deep to the fascia iliaca with the aim of blocking the femoral nerve (FN) and
lateral femoral cutaneous nerve (LFCN). The incisions for proximal femur
surgeries also involve cutting through the tensor fascia lata (TFL) muscle
which is supplied by the superior gluteal nerve which is a branch of the
sciatic nerve, arising from the lumbosacral plexus. The superior gluteal nerve
is not covered by the fascia iliaca block.By
means of this thesis study, we aim to assess the benefits and feasibility of
blocking the superior gluteal nerve by means of administering the Tensor Fascia
Lata Plane Block in addition to FICB for proximal femur surgeries.
RECRUITMENT
OF PATIENTS -During pre-anaesthetic check (Informed consent will be taken by
primary
investigator, patient is
randomised by double blinding technique before the procedure.
They are randomised into two
groups GROUP A (Fascia
Iliaca Compartment Block) and
GROUP B (Fascia Iliaca Compartment Block+ TFL Block)
>>Under
sterile aseptic precaution the anterior and lateral regions of the thigh at the
inguinal region and upper thigh will be painted and draped
>>The
ultrasound linear, high frequency transducer probe will be draped with sterile
cover and first placed at inguinal region.
>>The
femoral vessels, illiacus and sartorius muscle will be identified. The probe will
then be moved laterally till the tensor fascia lata muscle appears into view
after sartorius insertion
>>The
transducer will be moved further laterally and slightly downward the thigh to
identify the fascial plane between the TFL and the gluteus Medius. The superior
gluteal nerve along with its accompanying vessel – transverse branch of lateral
circumflex femoral artery enters the TFL muscle through its lower border
>>At
this point on the USG Sono anatomy .upon identifying the arterial pulsation at
the lower border of the muscle ,the block needle will be inserted from the
medial edge of the probe and advanced till the lower border of the TFL
>>Upon
reaching this point, the probe is moved 0.5 – 1 cm cranially from the point of
entry of the artery, and the drug will be injected after negative aspiration
.The expected endpoints will be drug spread along tensor fascia lata and the
gluteus Medius muscle
>>A single shot of 8-10 ml of 0.25% bupivacaine or 0.2% ropivacaine
with 0.2mcg/kg of dexmedetomidine will be administered after confirmation of
drug spread.
|