| CTRI Number |
CTRI/2025/12/099545 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study in adult patients with hip and upper thigh fractures to compare two injection methods for pain relief before giving spinal anesthesia.
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Scientific Title of Study
|
A Prospective Study to Compare the Efficacy of Fascia Iliaca Block Versus Femoral Nerve Block for Proximal Femur Fractures Before Positioning for Spinal Anesthesia in Adult Patients.
|
| 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 Gargi Yadav |
| Designation |
Resident doctor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex ,2nd Floor, Dhiraj
Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre , Waghodiya, Piparia ,Vadodara,GUJARAT,391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9571309076 |
| Fax |
|
| Email |
gargiy042@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSARA MARY THOMAS |
| Designation |
Professor and Head of Department |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex ,2nd Floor, Dhiraj
Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre , Waghodiya, Piparia ,Vadodara,GUJARAT,391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9646500158 |
| Fax |
|
| Email |
sara.cinosh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSARA MARY THOMAS |
| Designation |
Professor and Head of Department |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex ,2nd Floor, Dhiraj
Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre , Waghodiya, Piparia ,Vadodara,GUJARAT,391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9646500158 |
| Fax |
|
| Email |
sara.cinosh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Wagodhia , Pipariya,
Vadodara, Gujarat , India Pincode- 391760
Primary |
|
|
Primary Sponsor
|
| Name |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Center |
| Address |
Wagodhia , Pipariya, Vadodara, Gujarat , India Pincode- 391760 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gargi Yadav |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
2nd Floor, General OT complex, Anesthesia Department, Dhiraj hospital, Smt. Bhikiben Kanjibhai, Sumandeep Vidyapeeth Waghodia, Piparia, Vadodara Gujarat 391760 India Vadodara Gujarat
Vadodara
GUJARAT |
09571309076
gargiy042@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fascia Iliaca Block |
Patients will be administered landmark guided Fascia Iliaca Block with 30ml of 0.25% Isobaric Ropivacaine after arrival in operation theatre |
| Comparator Agent |
Femoral Nerve Block |
Patients will be administered Peripheral Nerve stimulation guided Femoral Nerve Block with 30ml of 0.25% Isobaric Ropivacaine after arrival in operation theatre. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are willing to provide written informed consent.
2. Male and female patients aged eighteen to eighty years.
3. Patients belonging to American Society of Anesthesiologists physical status one and two.
4. Patients with isolated proximal femoral fracture scheduled for elective surgery under spinal anesthesia.
|
|
| ExclusionCriteria |
| Details |
1. Patients unwilling to participate in the study.
2. Patients with other fractures of the lower limb along with proximal femur fracture.
3. Patients belonging to American Society of Anesthesiologists physical status three or more.
4. Patients with psychiatric illness.
5. Pregnant and lactating women.
6. Patients with a history of known allergy to the study drug.
7. Patients with infection at the injection site.
8. Patients with coagulation disorders or platelet count less than eighty thousand.
9. Patients with any contraindication to spinal anesthesia such as raised intracranial pressure, hemodynamic instability, or neurological disorders.
10. Patients with a history of previous femoral vascular surgery.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| efficacy for managing pain, positioning during proximal femur fracture surgeries conducted under spinal anesthesia |
efficacy for managing pain, positioning during proximal femur fracture surgeries conducted under spinal anesthesia at 3,5,7 & 10 minutes. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Time of onset of analgesia |
will be assessed and is defined as the time taken from administration of block to reduction of VAS from pre block value.
The patients will be made to sit for spinal anesthesia when the VAS score will be less than 4
|
| Monitoring of parameters like HR, SBP, DBP,SPO2 |
will be noted at baseline 5,10,15 minutes after the peripheral nerve block and every 15 minutes till the end of surgery |
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/12/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - sara.cinosh@gmail.com
- For how long will this data be available start date provided 20-11-2025 and end date provided 20-11-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
A prospective study to compare the efficacy of fascia iliaca block versus femoral nerve block for proximal femur fractures before positioning for spinal anesthesia in adult patients.
Objective to assess and compare the efficacy of Fascia Iliaca Block and Femoral Nerve Block for providing analgesia during patient positioning for spinal anesthesia using Visual Analogue Scale for pain.To compare the change in heart rate, blood pressure and saturation.
Inclusion criteria:Patients willing to sign informed consent Male or female patients between 18 to 80 years of age â Patients belonging to American Society of Anesthesia (ASA) grade I & II. Patients with isolated proximal femoral fracture posted for elective surgeries under Spinal Anesthesia.
Exclusion criteria: Patients unwilling to participate in the study. Patients with other fractures of lower limb along with proximal femur fracture. Patients belonging to ASA grade III or more. â Psychiatric patients â Pregnancy & lactating women. â History of known allergy to study drug. â Infection at injection site Coagulation disorders, platelet count less than 80,000. Any contraindication to spinal anesthesia like raised intracranial pressure, haemodynamic instability, neurological disorders. â Patients who had previous femoral vascular surgery.
In the supine position, under all aseptic precautions patients will be administered block.A 10 cm visual analogue scale (VAS) score will be recorded before the block and after the block at 3,5,7,10 minutes.Time of onset of analgesia will be assessed and is defined as the time taken from administration of block to reduction of VAS from pre block value.The patients will be made to sit for spinal anesthesia when the VAS score will be less than 4.
Site of Study:Department of Anaesthesiology, Dhiraj Hospital,S.B.K.S.Medical Instituteand Research Centre, Piparia, Waghodia, Vadodara, Gujarat.
Study Design- Prospective Observational Study
Study Duration-The study duration will be till 18 months after getting permission from institutional ethics committee.
Data will be Collected and organized, with numerical data summarized using mean and standard deviation (SD), and categorical data represented by frequency and percentage. For numerical variables, comparisons between groups will be conducted using methods such as unpaired student t-test and/or ANOVA when suitable. For categorical variables, the chi-square test will be applied. A Statistical significance level of p < 0.05 will be deemed statistically significant.
Likely outome/benifit: The study will provide insights into the comparative efficacy of fascia iliaca block (FIB) versus femoral nerve block (FNB) for managing pain, positioning during proximal femur fracture surgeries conducted under spinal anesthesia. |