| CTRI Number |
CTRI/2018/10/016120 [Registered on: 23/10/2018] Trial Registered Prospectively |
| Last Modified On: |
20/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO COMPARE THE EFFICACY OFINTRAOPERATIVE ERECTOR SPINAE BLOCK VERSUS SKIN INFILTRATION FOR POST OPERATIVE PAIN RELIEF IN SPINE SURGERIES |
|
Scientific Title of Study
|
TO COMPARE THE EFFICACY OF INTRAOPERATIVE LANDMARK GUIDED ERECTOR SPINAE PLANE BLOCK VERSUS SUBCUTANEOUS INFILTRATION TECHNIQUE FOR POST OPERATIVE ANALGESIA IN PATIENTS UNDERGOING THORACOLUMBAR SPINE SURGERIES- A RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
ESP BLOCK |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR JBALAVENKAT |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
GANGA HOSPITAL |
| Address |
Department of Anaesthesiology
GANGA HOSPITAL,
313, METTUPALAYAM ROAD
COIMBATORE, TAMIL NADU
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9842245757 |
| Fax |
|
| Email |
drbalavenkat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIPIN KUMAR GOEL |
| Designation |
JUNIOR CONSULTANT |
| Affiliation |
GANGA HOSPITAL |
| Address |
Department of Anaesthesiology
GANGA HOSPITAL,
313, METTUPALAYAM ROAD
COIMBATORE, TAMIL NADU
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9443369715 |
| Fax |
|
| Email |
drvipingoel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VIPIN KUMAR GOEL |
| Designation |
JUNIOR CONSULTANT |
| Affiliation |
GANGA HOSPITAL |
| Address |
Department of Anaesthesiology
GANGA HOSPITAL,
313, METTUPALAYAM ROAD
COIMBATORE, TAMIL NADU
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9443369715 |
| Fax |
|
| Email |
drvipingoel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deoartment of Anaesthesiology
Ganga hospital
313,Mettupalayam road
coimbatore, Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Ganga Hospital |
| Address |
313, Mettupalayam Road
Coimbatore, Tamil Nadu |
| 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 |
| DR J BALAVENKAT |
Ganga Hospital |
Department of Anaesthesiology,
Ganga Hospital
313, METTUPALAYAM ROAD
Coimbatore
TAMIL NADU |
9842245757
drvipingoel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R298||Other symptoms and signs involvingthe nervous and musculoskeletal systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ERECTOR SPINAE BLOCK |
Landmark technique erector spinae block given at the conclusion of the surgery using 40ml of 0.25% bupivacaine, 20ml on each side |
| Comparator Agent |
subcutaneous infiltration |
subcutaneous infiltration done along the incision line at the end of the surgery using 20 to 30 ml of 0.25%bupivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Elective spine fusion surgery
ASA I, II
No neurological deficit
|
|
| ExclusionCriteria |
| Details |
Fracture spine patient
Uncontrolled diabetes mellitus
Neurological deficit |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
VAS SCORE
DURATION OF ANALGESIA
|
VAS Score every 2 hour for 24 hours
Duration Of Analgesia upto 24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Consumption Of Opioid |
Consumption Of Opioid over 24hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
28/10/2018 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A prospective double blinded randomised control study to compare the efficacy of erector spinae block versus subcutaneous infiltration in patient undergong thoracolumbar surgeries. patients will get either landmark guided erector spinae block or subcutaneous infiltration using 0.25%bupivacaine on either side of incision line at the end of surgery. Postoperative pain assessment using VAS score and duration of the pain relief will be recorded and the total consumption of opioid. |