CTRI Number |
CTRI/2022/06/043059 [Registered on: 07/06/2022] Trial Registered Prospectively |
Last Modified On: |
29/05/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison between Femoral Nerve Block and Fascia Iliaca Compartment Block for reducing pain associated with positioning for spinal anaesthesia in proximal femur fracture surgery. |
Scientific Title of Study
|
A Randomised Comparative Study Of Ultrasound Guided Femoral Nerve Block Vs Fascia Iliaca Compartment Block For Reducing Pain Associated With Positioning For Spinal Anesthesia In Patients With Proximal Femur Fracture At SMS Hospital, Jaipur. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Mamta Khandelwal |
Designation |
Senior Professor |
Affiliation |
Sawai Man Singh Medical College, Jaipur |
Address |
Department Of Anaesthesiology, Second Floor, Dhanwantri Building, Sawai Man Singh Medical College, JLN Marg jaipur.
Jaipur RAJASTHAN 302015 India |
Phone |
9929338174 |
Fax |
|
Email |
drmamtakhandelwal@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mamta Khandelwal |
Designation |
Senior Professor |
Affiliation |
Sawai Man Singh Medical College, Jaipur |
Address |
Department Of Anaesthesiology, Second Floor, Dhanwantri Building, Sawai Man Singh Medical College, JLN Marg jaipur.
Jaipur RAJASTHAN 302015 India |
Phone |
9929338174 |
Fax |
|
Email |
drmamtakhandelwal@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Kanupriya |
Designation |
P.G Student |
Affiliation |
Sawai Man Singh Medical College, Jaipur |
Address |
Department Of Anaesthesiology, Second Floor, Dhanwantri Building, Sawai Man Singh Medical College, JLN Marg jaipur.
Jaipur RAJASTHAN 302015 India |
Phone |
9465920681 |
Fax |
|
Email |
kanupriya1095@gmail.com |
|
Source of Monetary or Material Support
|
Department Of Anaesthesiology, SMS Hospital, Jaipur. |
|
Primary Sponsor
|
Name |
Sawai Man Singh Medical College Jaipur |
Address |
Department Of Anaesthesiology, Second Floor, Dhanwantri OPD Block, Sawai Man Singh Medical College, JLN Marg, Jaipur |
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 Mamta Khandelwal |
Sawai Man Singh Medical College And Hospital, Jaipur. |
Department Of Anaesthesiology, Second Floor, Dhanwantri OPD Block, Sawai Man Singh Medical College And Hospital, JLN Marg, Jaipur. Jaipur RAJASTHAN |
9929338174
drmamtakhandelwal@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics Committee, SMS Medical College and Hospital, Jaipur. |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
43 Patients will receive Ultrasound guided Fascia Iliaca Compartment Block with 30ml of 0.25% Bupivacaine. |
Effect will be checked by pin prick sensation on anterior part of thigh. VAS Score will be recorded before and immediately after the block at every 1 min interval until VAS is less than 3. |
Comparator Agent |
43 Patients will receive Ultrasound guided Femoral Nerve block with 15ml of 0.25% Bupivacaine. |
Effect will be checked by pin prick sensation on anterior part of thigh. VAS Score will be recorded before and immediately after the block at every 1 min interval upto 15 min until VAS is less than 3. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
1.Patient undergoing elective surgery for proximal femur fracture unable to sit for SAB due to severe pain.(VAS >7)
2.Patients consenting to participate.
3.Adult patients aged 18-80 Years.
4.Patients belonging to American Society Of Anesthesiologists(ASA) grade I, II and III.
5.Weight 40-80 kgs. |
|
ExclusionCriteria |
Details |
1.Patients with psychiatric illness, anxious, agitated.
2.Patients with peripheral sensorineural deficit.
3.Patients allergic to local anesthetics.
4.Patients on anticoagulant therapy.
5.Infection at block site.
6.Patients with multiple trauma.
7.Patients with suspected compartment syndrome in lower limbs.
8.Patients on analgesia within 8 hours before performing nerve block.
9.Block failure cases.
|
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To determine the change in VAS score from baseline to post induction at different time intervals.
|
To determine the change in VAS score from baseline to post induction at different time intervals maximum up to 15 minutes (until the VAS score is less than 3)Â in both groups.
|
|
Secondary Outcome
|
Outcome |
TimePoints |
1.To estimate Anesthesiologist satisfaction score.
2.To determine the difference in mean time of first rescue analgesia in both groups by using VAS score.
3.To determine the difference in mean dose of analgesia required in both groups.
4.To determine the change in the haemodynamic parameters (HR,SBP,DBP,MAP and SpO2 )in both groups.
5.To observe side effect if any.
|
1.To estimate Anesthesiologist satisfaction score.
2.To determine the difference in mean time of first rescue analgesia in both groups by using VAS score.
3.To determine the difference in mean dose of analgesia required for 24 hours in both groups.
4.To determine the change in the haemodynamic parameters (HR,SBP,DBP,MAP and SpO2 )in both groups.
5.To observe side effect if any.
|
|
Target Sample Size
|
Total Sample Size="86" Sample Size from India="86"
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)
|
15/06/2022 |
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="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Patient randomization will be performed using computerized random number table, in which patient will be randomly allocated in a ratio of 1:1 to receive one of the two assigned blocks. Group A (n = 43) will receive Femoral nerve Block with 15 mL of 0.25% bupivacaine). Group B (n = 43) will receive Fascia iliaca compartment block with 30 mL of 0.25% bupivacaine). Depending on the allotted group, patients will receive the block under the guidance of ultrasound in the Operation Theatre under all aseptic precautions. Effect will be checked by pin prick on anterior part of thigh at every 2 min interval. VAS (Visual Analogue Scale) Score will be recorded before the block and immediately after the block at every 1 min interval upto 15 min until VAS is <3. The time taken to achieve VAS <3 will be noted. When VAS Score is achieved<3 under all aseptic precautions SAB will be given in sitting position in L3-L4 space using 0.5% hyperbaric Bupivacaine 12.5mg +25mcg of fentanyl using 25 gauze quinke’s needle. When adequate sensory and motor blockade will be achieved, surgery will be started. Intraoperative parameters such as Heart Rate, SBP, DBP, MAP andSpo2 will be monitored according to proforma. When surgery will complete patient will be shifted to PACU. Inj. Tramadol 100 mg will be given as rescue analgesia. Time for the need of first rescue analgesia will be noted. This time will be calculated from VAS<3 after the block to request of first rescue analgesia by patient at VAS >3.VAS Score will be assessed at hourly interval for first 6 hrs., 2 hrly interval for 12hrs, 4 hrly interval for 24 hrs.Total dose of Tramadol required in 24hrs will be noted. Anesthesiologist Satisfaction Score, and Patient’s satisfaction score will be assessed.Side effect if develop will be noted and managed accordingly. |