| CTRI Number |
CTRI/2025/07/090748 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A trial to understand the analgesics efficacy by different approach in a patient with hip bone fracture |
|
Scientific Title of Study
|
A Randomized double-blind study to compare the analgesic efficacy of Ultrasound guided supra-inguinal versus conventional infra-inguinal approach for fascia iliaca compartment block in patient with hip bone fracture |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Khursheed Jamal |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7808546960 |
| Fax |
|
| Email |
bunty4ever4u@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hammad Usmani |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897114190 |
| Fax |
|
| Email |
hammadusmani2002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hammad Usmani |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897114190 |
| Fax |
|
| Email |
hammadusmani2002@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, JNMCH, AMU, Aligarh, UP, 202002 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh |
| Type of Sponsor |
Government 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 Khursheed JAMAL |
JNMCH Hospital |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH |
7808546960
bunty4ever4u@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Jawaharlal Nehru Medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S741||Injury of femoral nerve at hip andthigh level, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparing the analgesic efficacy of 0.25% Bupivacaine by route of administration through different approaches in patients with unilateral hip bone fracture. |
All the patients will undergo intravenous cannulation and pre-anaesthetic evaluation. Base line pulse rate, blood pressure, SpO2, and respiratory rate will be recorded before undertaking the procedure.
The patients will be randomly divided into the two groups of 30 patients each.
1.Group S- Supra inguinal fascia iliaca block will be given under ultrasound guidance, using 20ml of 0.25% levobupivacaine.
2.Group I- Infra-inguinal fascia iliaca block will be given under ultrasound guidance, using 20ml of 0.25% levobupivacaine.
The duration of the procedure will be recorded. A successful block will be determined by the loss of pinprick sensation in the femoral, lateral femoral cutaneous, and obturator nerves innervated areas by checking at every 3 minutes. The areas that will be examined include the anterior thigh for the femoral nerve, the lateral thigh for the lateral femoral cutaneous nerve, and the inner thigh for the obturator nerve.
An observer blinded to the study groups will record the duration of pain relief in terms of time to first dose of rescue analgesic. The intensity of pain will be recorded in both groups at the following time points: before the procedure (T0) and at 1hr (T1), 3hr (T2), 12hr (T3), and 24 hr (T4) after the procedure. Pain intensity will be assessed using the Numeric rating scale(NRS) on a scale of 0–10, The NRS is horizontal line labelled as “no pain” at the 0 mark and “worst pain imaginable” on the other end i.e., 10cm mark.
Complications during the procedure and after the procedure will be recorded. This included bradycardia, hypotension, bleeding from the puncture site, any sign of local anaesthetic toxicity, nausea and vomiting. In addition, the number of fixed dose combination of tramadol and acetaminophen taken orally during first 24 hours will also be documented. |
| Comparator Agent |
Not applicable |
Comparator agent Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willingness to participate in the study.
2. Patient between 18 to 75 years of age.
3. A radiographically confirmed unilateral hip bone fracture with NRS score more than 8.
4. BMI between 18-30 kilogram per meter square
5. ASA Grade I and II.
|
|
| ExclusionCriteria |
| Details |
1) Having suffered from major trauma or fracture of other bone
2)Refusal to participate.
3)Manifesting coagulopathy or deranged INR.
4)Currently on chronic analgesics,
5)A history of allergy to local anesthetics,
6)An infection in the area where FICB was to be performed,
7)Having significant visual, hearing or cognitive impairment
8)History of alcohol or drug abuse
9)Neuro-vascular disorder in the affected leg |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of pain relief between supra-inguinal fascia iliaca compartment block (SIFIB) versus infra-inguinal fascia iliaca compartment block (IIFIB) in patient with unilateral hip bone fracture in terms of first dose of rescue analgesic. |
The intensity of pain will be recorded in both groups at the following time points: before the procedure (T0) and at 1hr (T1), 3hr (T2), 12hr (T3), and 24 hr (T4) after the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the degree of pain relief in terms of Numerical Rating Scale(NRS).
•To record analgesic consumption during first 24 hours.
•To report any complication or side effects. |
The intensity of pain will be recorded in both groups at the following time points: before the procedure (T0) and at 1hr (T1), 3hr (T2), 12hr (T3), and 24 hr (T4) after the procedure |
|
|
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" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/07/2025 |
| 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="2"
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 - 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 - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bunty4ever4u@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Title:
A Randomized Double-Blind Study to Compare the Analgesic Efficacy of Ultrasound-Guided Supra-Inguinal versus Conventional Infra-Inguinal Approach for Fascia Iliaca Compartment Block in Patients with Hip Bone Fracture Summary:
This prospective, randomized, double-blind clinical study, conducted at JNMC, AMU, aims to compare the analgesic effectiveness of ultrasound-guided supra-inguinal (SIFIB)versus infra-inguinal fascia iliaca compartment block (IIFIB) in patients with unilateral hip bone fractures. Hip fractures are common in the elderly and associated with severe pain and complications. The study includes 60 patients, randomly assigned to either SIFIB or IIFIB groups (30 each), to assess pain relief efficacy. The primary objective is to compare the duration of analgesia based on the time to first rescue analgesic dose. Secondary objectives include evaluating pain scores using the Numerical Rating Scale (NRS), total analgesic consumption over 24 hours, and recording any adverse effects or complications. This trial emphasizes the importance of early and effective regional analgesia as a safer alternative to opioids and NSAIDs, especially in elderly patients with comorbidities. |