| CTRI Number |
CTRI/2024/02/062327 [Registered on: 06/02/2024] Trial Registered Prospectively |
| Last Modified On: |
05/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of a drug dexmedetomidine in fascia iliaca compartment block to relieve pain of fracture of thigh bone to provide adequate positioning for spinal anaesthesia |
|
Scientific Title of Study
|
Comparison Of Bupivacaine Versus Bupivacaine With Dexmedetomidine in Fascia Iliaca Compartment Block To Provide Analgesia For Positioning Femur Fracture Patients Before Spinal Anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Utsavi Yakeshkumar Shah |
| Designation |
Resident doctor |
| Affiliation |
Government medical college, Vadodara |
| Address |
Department of anaesthesiology, SSG Hospital, Government medical college , Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9909848918 |
| Fax |
|
| Email |
utsavi1595@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Darshna patel |
| Designation |
Associate Professor |
| Affiliation |
Government medical college, Vadodara |
| Address |
Department of anaesthesiology, SSG Hospital, Government medical college , Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9925013155 |
| Fax |
|
| Email |
dr.darshna1968@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darshna patel |
| Designation |
Associate Professor |
| Affiliation |
Government medical college, Vadodara |
| Address |
Department of anaesthesiology, SSG Hospital, Government medical college , Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9925013155 |
| Fax |
|
| Email |
dr.darshna1968@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, SSG Hospital, Vadodara |
|
|
Primary Sponsor
|
| Name |
Government medical college, Vadodara |
| Address |
Department of Anaesthesiology, SSG Hospital, Government medical college Vadodara |
| 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 |
| Utsavi Shah |
SSG Hospital ,Vadodara |
Ortho OT,Operation theatre Block, First Floor, ,Baroda medical college
Vadodara
GUJARAT |
9909848918
utsavi1595@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health Research (IECBHR) Medical college,SSG Hospital,Vadodara |
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 |
| Comparator Agent |
Ultrasound guided fascia iliaca compartment block using bupivacaine along with dexmedetomidine before spinal anaesthesia |
Using a linear transducer probe over inguinal ligament in supine position, fascia iliaca plane identified and confirmed by hydro dissection. Total volume 28 ml of 0.25% bupivacaine + 50 mcg of dexmedetomidine in 2 ml of normal saline injected.Onset of effect defined time taken from injection of drug into fascia iliaca compartment till VAS score of ≤4. when the VAS score will be ≤4, patients will be given sitting position for spinal anaesthesia. |
| Intervention |
Ultrasound guided fascia iliaca compartment block using bupivacaine before spinal anaesthesia |
Using a linear transducer probe over inguinal ligament in supine position, fascia iliaca plane identified and confirmed by hydro dissection. Total volume of 28 ml of 0.25 % bupivacaine +2 ml of normal saline is injected .Onset of effect defined time taken from injection of drug into fascia iliaca compartment till VAS score of ≤4. when the VAS score will be ≤4, patients will be given sitting position for spinal anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I, II, III
femur fracture patient operated under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1.Patients with contraindications for subarachnoid block like refusal for spinal anaesthesia, local infection ,patients with raised intracranial tension and coagulopathy
2. Morbid obesity
3. Patients with uncontrolled Diabetes Mellitus, Hypertension, cerebrovascular disease, liver and renal disease
4. Patients with multiple bone fractures
5. Pregnant and lactating mothers
6. Patients with psychiatric illness
7. Patients with peripheral sensorineural deficit
8. Patients with drug addiction or alcohol abuse |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual analogue scale at 5 ,10,15,20 minutes after fascia iliaca compartment block |
at baseline, 5min,10min,15min,20min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patient acceptance score |
at the end of surgery |
| Duration of analgesia |
immediately post,1 hour,2hour,4 hour,6hour,8hour,12hour,16hour,20hour,24hour |
| Number of rescue analgesic doses required in 24 hours |
in 24 hour |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
14/02/2024 |
| 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="0"
Months="6"
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
|
This study is randomised prospective comparative clinical study evaluate the addition of dexmedetomidine to bupivacaine in FICB to provide analgesia for positioning femur fracture patients before spinal anaesthesia will lead to rapid achievement of ease of positioning as well as prolonged duration of postoperative analgesia.
After pre aneasthestic evaluation and 6 -8 hours of fasting , informed written consent will be taken from the patient .Then patient will be taken inside operation theatre , multipara monitors will be attached and all baseline vital parameters and baseline VAS score will be recorded .Premedication and Adequate pre loading will be done.
Ultrasound-guided FICB is usually performed with the patient lying in the supine position. The Femoral artery is visualized by placing the transducer transversely on the inguinal crease, followed by slightly moving the probe either medially or laterally. The fascia iliacaplane which is hyper echoic is identified superficial to the hypo-echoic iliopsoas muscle. Medially in the fascia iliaca compartment , the femoral nerve is identified deep to the fascia and lateral to the Femoral artery.
Grouping of the patient : - The study population will be randomly allocated into two groups by computer generated random numbers.
Group B:- 28 ml of 0.25% bupivacaine+2 ml of normal saline in USG guided FICB Group BD-: 28 ml of 0.25% bupivacaine+ 50 mcg of dexmedetomidine in 2 ml of normal saline in USG guided FICB
Subarachnoid block will be given with 3 ml of 0.5% hyperbaric bupivacaine when the VAS score will be <4.
Following parameter will be recorded in both the group:
1) Visual analogue scale score at 5,10,15,20 minutes after FICB.
2) Ease of spinal positioning score
3)patient acceptance score
4)Duration of analgesia
5)Number of rescue analgesic doses required in 24 hours
|