| CTRI Number |
CTRI/2021/01/030323 [Registered on: 07/01/2021] Trial Registered Prospectively |
| Last Modified On: |
06/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study of Lower back injection of local anaesthetic in muscular plane on both sides of midline for pain relief in lumbar spine surgeries under ultrasound guidance . |
|
Scientific Title of Study
|
A clinical comparative study of ultrasound guided bilateral erector spinae block with 0.25% Bupivacaine and placebo for post operative pain management in elective lumbar spine surgeries . |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSreeraghu G M |
| Designation |
Professor |
| Affiliation |
kempegowda institute of medical sciences |
| Address |
Kempegowda institute of medical sciences, bangalore
KIMS, bangalore
Bangalore
KARNATAKA
560004
India |
| Phone |
8310285860 |
| Fax |
|
| Email |
aimsraghu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSreeraghu G M |
| Designation |
Professor |
| Affiliation |
kempegowda institute of medical sciences |
| Address |
Kempegowda institute of medical sciences, bangalore
KIMS, bangalore
Bangalore
KARNATAKA
560004
India |
| Phone |
8310285860 |
| Fax |
|
| Email |
aimsraghu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrBhavana |
| Designation |
Junior resident |
| Affiliation |
Kempegowda institute of medical sciences |
| Address |
#308 , PG resident quarters , Kims , Bangalore , Department of Anaesthesia.
#308 , PG resident quarters , KIMS, Bangalore , Department of Anaesthesia
Bangalore
KARNATAKA
560004
India |
| Phone |
9535755274 |
| Fax |
|
| Email |
madhurulesu@gmail.com |
|
|
Source of Monetary or Material Support
|
| DrBhavana(self), KIMS Bangalore , Department of Anaesthesia , PG quaters room 308. |
|
|
Primary Sponsor
|
| Name |
DrBhavana |
| Address |
#308, PG resident quaters KIMS, Bangalore, Department of Anaesthesia. |
| Type of Sponsor |
Other [] |
|
|
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 |
| DrBhavana |
Kempegowda institute of medical sciences |
Department of Anaesthesia, A block ,4th floor , Kempegowda institute of medical sciences, Bangalore
Bangalore
KARNATAKA |
9535755274
madhurulesu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy, (2) ICD-10 Condition: M513||Other thoracic, thoracolumbar andlumbosacral intervertebral disc degeneration, (3) ICD-10 Condition: M518||Other thoracic, thoracolumbar andlumbosacral intervertebral disc disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A clinical comparative study of ultrasound guided bilateral erector spinae block with 0.25% bupivacaine and placebo for post operative pain management in elective lumbar spine surgeries. |
under ultrasound guidance bilaterally erector spinae block with 20ml of 0.25%bupivacaine and placebo that is 20ml of normal saline on each side is given in elective lumbar spine surgeries .Frequency of administration - 1 (once ) . Duration of analgesia post administration will be noted. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 AND 2
SCHEDULED FOR ELECTIVE SPINE SURGERIES |
|
| ExclusionCriteria |
| Details |
ASA 3 AND 4
COAGULATION ABNORMALITIES
Patients on anticoagulants and antiplatelet
Pregnant and Lactating
local site skin infection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| post operative analgesia and decrease in use rescue analgesics in patients undergoing elective lumbar spine surgeries. |
From closure at surgery site upto 24hrs post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
15/01/2021 |
| 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="0"
Months="6"
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
|
this study is to assess the post operative analgesia and to decrease the use of rescue analgesics in patients undergoing elective lumbar spine surgeries. |