| CTRI Number |
CTRI/2021/08/035919 [Registered on: 25/08/2021] Trial Registered Prospectively |
| Last Modified On: |
24/08/2021 |
| 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 to determine analgesic effects of femoral nerve block for positioning for spinal anesthesia and for post operative analgesia |
|
Scientific Title of Study
|
A Prospective Study to Determine the Efficacy of Preoperative Ultrasound Guided Femoral nerve block for Positioning and Immediate Postoperative analgesia in Fracture Femur Surgery under Spinal Anaesthesia in Geriatric Patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nivedita |
| Designation |
third year resident |
| Affiliation |
Sardar Patel Medical College, Bikaner |
| Address |
Department of Anaesthesiology, Sardar Patel Medical College, Bikaner, Rajasthan
Bikaner, Rajasthan
334001
India
Bikaner
RAJASTHAN
334001
India |
| Phone |
7889156292 |
| Fax |
|
| Email |
niveditadr93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanta Bhati |
| Designation |
Senior Professor and Former Head |
| Affiliation |
Sardar patel medical college, Bikaner |
| Address |
Department of Anaesthesiology, PBM hospital, Bikaner.
Rajasthan.
Bikaner
RAJASTHAN
334001
India |
| Phone |
8619587428 |
| Fax |
|
| Email |
drkantabhati67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanta Bhati |
| Designation |
Senior Professor and Former Head |
| Affiliation |
Sardar patel medical college, Bikaner |
| Address |
Department of Anaesthesiology, PBM hospital, Bikaner.
Rajasthan.
Bikaner
RAJASTHAN
334001
India |
| Phone |
8619587428 |
| Fax |
|
| Email |
drkantabhati67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar Patel Medical College, Bikaner, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Sardar Patel Medical College Bikaner |
| Address |
Department of Anaesthesiology, PBM hospital, Bikaner.
Rajasthan. |
| 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 |
| Nivedita |
Sardar Patel Medical College,Bikaner |
Department of Anaesthesiology, PBM hospital, Bikaner.
Rajasthan.
Bikaner
RAJASTHAN |
7889156292
niveditadr93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Research Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Femoral nerve block and Spinal Anesthesia |
We are giving femoral nerve block with local anesthetic Inj Bupivacaine 20 ml 0.5% before spinal anesthesia to check for its analgesic effects for positioning and post operative analgesia. |
| Comparator Agent |
standard management |
intravenous diclofenac 75 mg |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
ASA I TO III,
FRACTURE FEMUR SURGERIES,
BMI 18.5-23.9 |
|
| ExclusionCriteria |
| Details |
PATIENT REFUSAL
BLEEDING DIATHESIS
HISTORY OF DRUG HYPERSENSITIVITY TO LOCAL ANAESTHESIA
LOCAL INFECTION AT INJECTION SITE
SEPTICAEMIA |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS SCORE OF PATIENT IN FIRST 24 HOURS,PATIENT SATISFACTION SCORE, TIME OF FIRST DOSE RESCUE |
VAS Score - day 1
Patient satisfaction score - day 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PATIENT SATISFACTION SCORE,
TO ACCESS HEMODYNAMIC STABILITY |
48 HOURS |
|
|
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)
|
01/09/2021 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We conducted a prospective double blinded randomized control study in 60 patients of both sexes, aged > than 60 years, belonging to ASA I, II & III undergoing fracture femur surgeries in Sardar Patel Medical College, Bikaner (Rajasthan). Approval from Institutional Ethical Committee and valid written informed consent from patients was taken before starting the study. Our aim was to check the efficacy and safety of ultrasound guided femoral nerve block its onset, duration and quality of sensory & motor block. Patients were divided into 2 groups of 30 each using randomization. Group A received intrathecal Inj.0.5% heavy bupivacaine with Fentanyl 0.25 ug into subarachnoid space whereas Group B received femoral nerve block along with spinal anaesthesia. After the procedure, onset, peak block and quality of patient positioning for spinal anaesthesia was checked. Along with this MAP and Heart rate were also observed and noted in both the groups. Postoperative analgesia in terms of VAS score, time to first dose rescure and patient satisfaction score is measured. Conclusion : the femoral nerve bock have found to provide better post operative analgesia and better patient positioning for spinal anaesthesia compared to standard management. |