| CTRI Number |
CTRI/2021/12/038662 [Registered on: 15/12/2021] Trial Registered Prospectively |
| Last Modified On: |
13/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare between 2 types of nerve block to for relieve pain after bone surgery. |
|
Scientific Title of Study
|
Comparison of ultrasound guided Lumbar Erector Spinae Plane block versus Ultrasound guided Fascia Iliaca Compartment block for postoperative analgesia after femoral surgeries-A randamized control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranjitha K V |
| Designation |
Postgraduate |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Department of Anesthesia,
Bangalore Baptist Hospital, Bellary Rd, Vinayakanagar, Hebbal, Bengaluru,
Bangalore
KARNATAKA
560024
India |
| Phone |
9741614845 |
| Fax |
|
| Email |
ranjithakv65@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laji Abraham Samuel |
| Designation |
Head of the Department |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Department of Anesthesia,
Bangalore Baptist Hospital, Bellary Rd, Vinayakanagar, Hebbal, Bengaluru,
Bangalore
KARNATAKA
560024
India |
| Phone |
8317397242 |
| Fax |
|
| Email |
Drlajisamuel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laji Abraham Samuel |
| Designation |
Head of the Department |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Department of Anesthesia,
Bangalore Baptist Hospital, Bellary Rd, Vinayakanagar, Hebbal, Bengaluru,
KARNATAKA
560024
India |
| Phone |
8317397242 |
| Fax |
|
| Email |
Drlajisamuel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Baptist Hospital |
|
|
Primary Sponsor
|
| Name |
Bangalore Baptist Hospital |
| Address |
Bellary Rd, Vinayakanagar, Hebbal, Bengaluru, Karanataka |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| RANJITHA K V |
Bangalore Baptist Hospital |
First Floor,
Department of Anesthesiology
Bangalore Baptist Hospital
Hebbal
Bangalore
Bangalore
KARNATAKA |
9741614845
ranjithakv65@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review board,Bangalore Baptist Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group B:Fascia iliaca compartment block with Inj Bupivacaine 0.25% 35ml |
In USG guided, Fascia iliac compartment block technique, identify the femoral artery and iliopsoas muscle and fascia iliaca. The transducer is moved laterally untill the sartorius muscle is identified. after a skin wheal is made, the needle is inserted in-plane. As the needle passes through fascia iliaca, the fascia is first seen idented by the needle.
As the needle eventually pierces the fascia, a pop may be felt, and the fascia may be seen to snap back on the US image. After negative aspiration, 1-2 ml of local anesthetic is injected to confirm the proper injection plane between the fascia and iliopsoas of the muscle.proper injection will result in the separation of the fascia iliaca by the local anesthetic in the medial-lateral direction from the point of injection.Drug will be given.Total duration of therapy for 24 hrs . |
| Intervention |
Group B:Lumbar Erector Spinae Plane block with Inj Bupivacaine 0.25% 35 ml |
The 4th lumbar vertebral level will be determined using the conventional method. The convex USG transducer will be placed at the mid-vertebral line in the sagittal plane. Transducer will be shifted from the midline, 3.5- 4 cm laterally to the side of the surgery to visualize the erector spinae muscle and transverse process. Using the in plane technique a 22 G/100 mm block needle will be advanced until it reaches the transverse process. 0.5-1 ml of saline solution administeration leading to hydrodissection to confirm location. The needle will be repositioned by pulling back a few millimeters if resistance occurred when administering saline. 0.25% Bupivacaine will be administered to this location between the transverse process and the erector spinae muscle.Total duration of therapy for 24 hrs. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patient of ASA(American Society of Anesthesiologist) physical status 1,2,3
Elective and emergency femur surgeries |
|
| ExclusionCriteria |
| Details |
Refusal of consent for study
Patient with bleeding or coagulation abnormalities or on therapeutic anticoagulants medications
Infection or injury at the injection site
Patients with significant preexisting neurological deficits, both central and peripheral
Acute polytrauma cases
Patient with history of allergy to local anesthetic/Diclofenac
Hemodynamically unstable patients or those requiring postoperative ventilation |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Efficacy of post operative analgesia(till 24hrs after shifting out from OT) as evaluated by numerical rating scale
2)Total rescue analgesia use(till 24 hrs after shifting out from OT)
3)Proportion of patient who requires rescue analgesia |
1)Efficacy of post operative analgesia(till 24 hrs after shifting out from OT) as evaluated by numerical rating scale
2)Total rescue analgesia use(till 24 hrs after shifting out from OT)
3)Proportion of patient who requires rescue analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Incidence of any adverse events
2)Assessment of motor power in both groups |
within first 24 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)
|
23/12/2021 |
| 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
|
not done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to compare the effects of ultrasound-guided Lumbar erector spinae plane block versus ultrasound-guided Fascia iliaca Compartment block for postoperative analgesia following femur surgeries. The two groups will be assessed in terms of efficacy of analgesia, as measured by a standardized pain assessment score. The requirement of rescue analgesia in the first 24hours and proportions of patients who requires will also be assessed. Nausea , vomiting and residual motor weakness in both the groups will be recorded. We want to know if the Lumbar Erector Spinae block provides as good or better postoperative analgesia than the Fascia Iliaca Compartment block as part of a multimodal analgesia for femoral surgeries. |