| CTRI Number |
CTRI/2024/10/074902 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Surgical/Anesthesia Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Pain Relief Methods for Elderly Patients with Hip Fractures: Single-Shot vs. Continuous Nerve Block Using Ropivacaine in the Emergency Room. |
|
Scientific Title of Study
|
"Analgesic Efficacy of Single-shot Versus Continuous Supra-inguinal Fascia Iliaca Compartment Block (S-FICB) using Ropivacaine for Elderly Proximal Femur Fracture patient ni the EmergencyDepartment: ARandomizedControledStudy." |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhasree Das |
| Designation |
Assistant Professor |
| Affiliation |
Department Of Trauma and Emergency,AIIMS Bhubaneswar |
| Address |
Trauma and Emergency office,Department of Trauma & Emergency.New Trauma Building. All India Institute Of Medical Sciences,Bhubaneswar AIIMS,Bhubaneswar Khordha ORISSA 751019 India |
| Phone |
7978885193 |
| Fax |
|
| Email |
drkakalee@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Subhasree Das |
| Designation |
Assistant Professor |
| Affiliation |
Department Of Trauma and Emergency,AIIMS Bhubaneswar |
| Address |
Trauma and Emergency office,Department of Trauma & Emergency.New Trauma Building. All India Institute Of Medical Sciences,Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
7978885193 |
| Fax |
|
| Email |
drkakalee@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Subhasree Das |
| Designation |
Assistant Professor |
| Affiliation |
Department Of Trauma and Emergency,AIIMS Bhubaneswar |
| Address |
Trauma and Emergency office,Department of Trauma & Emergency.New Trauma Building. All India Institute Of Medical Sciences,Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
7978885193 |
| Fax |
|
| Email |
drkakalee@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMSBHUBANESWAR |
| Address |
At-Sijua,PO.Patrapada,Bhubaneswar,Khorda,Odisha,India ,751019 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Subhasree Das |
AIIMS Bhubaneswar |
Yellow zone of Trauma and Emergency ,Department of Trauma and Emergency,
Khordha ORISSA |
7978885193
drkakalee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE AIIMS BHUBANESWAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S720||Fracture of head and neck of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
continuous Suprainguinal Fascia Iliaca Block |
will receive 30 ml of 0.2 % Ropivacaine followed by 7 ml/hr continuous infusion of 0.125% Ropivacaine by an elastomeric infusion pump after placement of continuous catheter in the intrafascial plane and it will be kept for 24 hr and patient will be observed for 24 hour. |
| Intervention |
single-shot Suprainguinal-Fascia Iliaca Compartment Block (S -FICB) |
Single-shot Suprainguinal-Fascia Iliaca Compartment Block (S -FICB) will receive 30 ml of 0.2 % Ropivacaine under USG in Infascial plane and patient will be observed for 24 hour. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex aged 60 years to 90 years with (ASA) physical status I-IV presenting to ED with acute proximal femur fracture |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1) other organ severe trauma with unstable hemodynamics at the presentation.
2) coagulation disorder
3) Taking Analgesics for a longer duration or with opioid addiction
4) History of allergy to local anesthetics
6) Having cognitive impairment.
7) Puncture site infection
8) Abnormal neurological status of the lower limbs
9) voluntary withdrawal by patients
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
We will evaluate the Visual Analogue Scale at rest. The baseline value (T0),30 minutes after procedure (T1),subsequently at 6 hours( T2),12 hours(T3) and 24 hours(T4) following the block.
|
We will evaluate the Visual Analogue Scale at rest. The baseline value (T0),30 minutes after procedure (T1),subsequently at 6 hours( T2),12 hours(T3) and 24 hours(T4) following the block.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
MAP, HR, SPO2 at the time of evaluation of VAS
The amount of opioids as a rescue analgesia
Time for resque analgesia
Duration of sleep in 24-hr
Adverse effects related to LA, Block and related Catheter within 24 hours following the block.
|
At rest,30 minutes,6hr,12 hr ,24 hr following the procedure |
|
|
Target Sample Size
|
Total Sample Size="54" Sample Size from India="54"
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)
|
19/10/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 proximal femur fractures, comprising 20% of all fractures in the elderly, are rising due to the aging population. Intense pain associated with proximal femur fractures can be worsened by position changes during examination, transport, or treatment. This augmented pain response can trigger adverse cardiovascular and cerebrovascular complications. The Fascia Iliac Block is increasingly used to reduce hip fracture pain. In recent years, USG -a guided supra-inguinal FICB approach has emerged as a novel method for performing FICB. It is safely performed with minimal risk as the needle trajectory does not cross major vessels, and the intended site of drug deposition is relatively superficial. The Supra inguinal approach, a recent advance over the conventional approach, ensures a more consistent spread of Local anesthetics (LA). It provides (80%) sensory blockade of the thigh than the previous method(30%). The single-shot S-FICB provides analgesia for approximately eight hours, and few other studies show that its effect starts wearing off around 24 hrs. We wanted to prolong the analgesia period by inserting a catheter and providing continuous LA infusion through the elastomeric infusion system without electricity. It gives a consistent supply of drugs and does not require detachment during transportation. Hence this study is designed to assess and compare the analgesic efficacy of USG-guided single-shot Suprainguinal Fascia Iliaca Compartment Block (S-FICB) to Continuous S-FICB using a continuous catheter and infusing through an elastomeric infusion pump in elderly patients with proximal femur fracture presenting to to the Emergency Department (ED). |