| CTRI Number |
CTRI/2021/07/034977 [Registered on: 19/07/2021] Trial Registered Prospectively |
| Last Modified On: |
08/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing Two Nerve Block Techniques Used to Reduce Pain among Patients with Thigh Bone Fracture While Being Positioned for Spinal Anaesthesia |
|
Scientific Title of Study
|
A Randomised Controlled Study Comparing Ultrasound Guided Fascia Iliaca Compartment Block and Femoral Nerve Block for Positioning Patients with Proximal Femur Fracture for Subarachnoid Block |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anirudh Pai P |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal, MAHE Manipal. |
| Address |
Department of Anaesthesiology
Kasturba Medical College, Manipal
MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9482513447 |
| Fax |
|
| Email |
anirudpai@live.co.uk |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rama Rani K |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal, MAHE Manipal. |
| Address |
Department of Anaesthesiology
Kasturba Medical College, Manipal
MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9902938044 |
| Fax |
|
| Email |
dr_rrk@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Anirudh Pai P |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal, MAHE Manipal. |
| Address |
Department of Anaesthesiology
Kasturba Medical College, Manipal
MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9482513447 |
| Fax |
|
| Email |
anirudpai@live.co.uk |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal
MAHE, Manipal |
|
|
Primary Sponsor
|
| Name |
Dr Anirudh Pai P |
| Address |
Department of Anaesthesiology
Kasturba Medical College, Manipal
MAHE, Manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Rama Rani K |
Department of Anaesthesiology
Kasturba Medical College, Manipal
MAHE, Manipal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anirudh Pai P |
Kasturba Hospital |
Kasturba Medical College, Manipal
MAHE, Manipal
Udupi
KARNATAKA |
9482513447
anirudpai@live.co.uk |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Ultrasound Guided Fascia Iliaca Compartment Block |
Under ultrasound guidance, fascial iliaca compartment block will be given with 30 ml 1:1 mixture of 0.25% Levobupivacaine and 2% Lignocaine with adrenaline. |
| Intervention |
Ultrasound Guided Femoral Nerve Block |
Under ultrasound guidance, femoral nerve block will be given with 15 ml 1:1 mixture of 0.25% Levobupivacaine and 2% Lignocaine with adrenaline. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to Americal Society of Anesthesiologists Physical Status I, II and III.
All patients undergoing surgery for proximal femur fracture under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patient refusal.
Subjects with allergy to the drugs involved in the study.
Contraindications to central neuraxial anaesthesia.
Infection at the site of block.
Use of analgesics 8 hours prior to the administration of the block.
Subjects with peripheral sensorineural deficits.
Patients with poor cognitive function which might lead to difficulties in assessing pain scores. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken for sensory blockade after administration of the block |
At baseline, 1 minute, 3 minutes, 5 minutes, 10 minutes and 15 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain score is assessed using the Numerical Pain Rating Scale |
Pain score will be measured upon arrival of the patient to the premedication area, followed by 1, 3, 5 and 10 minutes after the block administration. Pain score will be assessed again while positioning the patient for subarachnoid block. |
| Ease for subarachnoid block measures according to the time taken as well as number of attempts of needle insertion. |
Time measured starting from positioning of the patient for subarachnoid block till drug injection is completed. |
| Hemodynamic parameters |
Recorded upon arrival to the premedication area, followed by 1, 3, 5 and 10 minutes after nerve block administration. |
| Patient satisfaction score measured as per 5-point Likert scale |
Measured after the subarachnoid block has been given. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/07/2021 |
| Date of Study Completion (India) |
16/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients with proximal femur fractures undergoing surgical treatment for the same are usually operated under subarachnoid block. Positioning for the subarachnoid block can be painful. The purpose of this study is to compare ultrasound-guided fascia iliaca compartment block and ultrasound-guided femoral nerve block, which will be given prior to positioning of patients with a proximal femur fracture, for subarachnoid block, which will alleviate the pain during positioning.
Null hypothesis: There is no difference in outcomes between ultrasound-guided fascia iliaca compartment block and ultrasound-guided femoral nerve block.
Alternative hypothesis: There is a difference in outcomes between ultrasound-guided fascia iliaca compartment block and ultrasound-guided femoral neve block.
|