| CTRI Number |
CTRI/2023/10/058655 [Registered on: 13/10/2023] Trial Registered Prospectively |
| Last Modified On: |
06/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two techniques of Pain relief - Supra Inguinal Fascia Iliaca Block versus Femoral Nerve Block under Ultrasound guidance - for positioning(sitting position) for Spinal Anaesthesia in patients with Fracture Neck of Femur (Thigh bone) Surgery |
|
Scientific Title of Study
|
Comparison of Supra Inguinal Fascia Iliaca Block versus Femoral Nerve Block under Ultrasound guidance as analgesia before Central neuraxial block in the sitting position for Fracture Neck of Femur Surgery –A Prospective Randomized Clinical Trial in Tertiary Care Centre. |
| 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 Nisheed Joseph |
| Designation |
Assistant Professor |
| Affiliation |
Kodagu Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
Kodagu Institute of Medical Sciences, Madikeri, Karnataka
Kodagu
KARNATAKA
571201
India |
| Phone |
9545566263 |
| Fax |
|
| Email |
nisheedjoseph@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisheed Joseph |
| Designation |
Assistant Professor |
| Affiliation |
Kodagu Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
Kodagu Institute of Medical Sciences, Madikeri, Karnataka
Kodagu
KARNATAKA
571201
India |
| Phone |
9545566263 |
| Fax |
|
| Email |
nisheedjoseph@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisheed Joseph |
| Designation |
Assistant Professor |
| Affiliation |
Kodagu Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
Kodagu Institute of Medical Sciences, Madikeri, Karnataka
Kodagu
KARNATAKA
571201
India |
| Phone |
9545566263 |
| Fax |
|
| Email |
nisheedjoseph@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kodagu Institute of Medical Sciences, Madikeri, Karnataka -571201 |
|
|
Primary Sponsor
|
| Name |
Dr Nisheed Joseph |
| Address |
Assistant Professor, Department of Anaesthesiology, Kodagu Institute of Medical Sciences,Madikeri, Karnataka - 571201 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Gayathri Subhash Banasode |
Assistant Professor, Department of Anaesthesiology, Kodagu Institute of Medical Sciences,Madikeri, Karnataka - 571201 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nisheed Joseph |
Kodagu Institute of Medical Sciences |
Assistant Professor, Department of Anaesthesiology, Kodagu Institute of Medical Sciences,Madikeri
Kodagu
KARNATAKA |
9545566263
nisheedjoseph@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kodagu Institute of Medical Sciences,Madikeri, Karnataka - 571201 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M844||Pathological fracture, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Femoral Nerve block |
F group will receive an Ultrasound-guided femoral Nerve block according to the standard procedure with a 5cm 20 G Teflon coated, short bevel Stimuplex needle with the patient in the supine position. The block will be performed with a 20ml solution of 1% Lignocaine with adrenaline. |
| Intervention |
Supra Inguinal Fascia Iliaca Block |
S group will receive an Ultrasound-guided Supra Inguinal Facia Iliac Block according to the standard procedure with a 5cm, 20 G Teflon coated, short bevel Stimuplex needle with the patient in the supine position. The block will be performed with a 30ml solution of 1% Lignocaine with adrenaline.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 and above
2.Patients with a fracture neck femur, undergoing surgery under the subarachnoid block,
3.ASA physical status I and II
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Known hypersensitivity to local anesthetic agents of the amide type
3.Anticoagulant therapy (warfarin/heparin infusion).
4.Clotting disorders [international normalized ratio (INR) or activated partial thromboplastin time ratio (APTR)] more than 1.5, Platelets less than 80,000/microL
5.Previous femoral vascular surgery
6.Hepatic Impairment
7.Debilitated or acutely ill patients
8.Glasgow Coma Scale (GCS) less than 12/15
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To observe the effectiveness of Supra Inguinal Fascia Iliaca Block and Femoral Nerve Block under Ultrasound guidance as analgesia before Central neuraxial block in the sitting position for Fracture Neck of Femur Surgery. The following objectives are set.
To compare the time required for the onset of sensory block after both techniques. |
The patient will be assessed for pain with Visual Analogue Scale at 0, 2, 5, 10, 15, 20min, and after giving a sitting position and the time will be noted with Zero being the time of giving block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To identify the dermatomal coverage of the block (femoral, obturator, and lateral femoral cutaneous nerve) after both techniques
2.To assess the adequacy of patient positioning for administering central neuraxial block after both techniques. |
The patient will be assessed for pain with Visual Analogue Scale at 0, 2, 5, 10, 15, 20min, and after giving a sitting position and the time will be noted with Zero being the time of giving block. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2023 |
| 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
|
A Prospective Randomized Clinical trial, double blinded, to observe the effectiveness of Supra Inguinal Fascia Block and Femoral Nerve Block under Ultrasound guidance as analgesia before Central Neuraxial block in the sitting position for 60 patients for Fracture Neck of Femur Surgery in a tertiary centre for a duration of 1 year. |