| CTRI Number |
CTRI/2020/06/026041 [Registered on: 22/06/2020] Trial Registered Prospectively |
| Last Modified On: |
09/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare the postoperative pain relief with caudal epidural block and erector spinae plane block in lower back disc surgery under general anaesthesia |
|
Scientific Title of Study
|
Compare the postoperative analgesic efficacy of caudal epidural block and ultrasound guided bilateral erector spinae plane block in patients undergoing lumbar discectomy surgery under GA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Smita Musti |
| Designation |
Assistant Professor |
| Affiliation |
M S Ramaiah Medical College Bangalore |
| Address |
Dr Smita Musti
Department of Anaesthesia
M S Ramaiah Medical College
Bangalore
Dr Smita Musti
Department of Anaesthesia
M S Ramaiah Medical College
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9886125842 |
| Fax |
|
| Email |
smitamusti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Musti |
| Designation |
Assistant Professor |
| Affiliation |
M S Ramaiah Medical College Bangalore |
| Address |
Dr Smita Musti
Department of Anaesthesia
M S Ramaiah Medical College
Bangalore
Dr Smita Musti
Department of Anaesthesia
M S Ramaiah Medical College
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9886125842 |
| Fax |
|
| Email |
smitamusti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita Musti |
| Designation |
Assistant Professor |
| Affiliation |
M S Ramaiah Medical College Bangalore |
| Address |
Dr Smita Musti
Department of Anaesthesia
M S Ramaiah Medical College
Bangalore
Dr Smita Musti
Department of Anaesthesia
M S Ramaiah Medical College
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9886125842 |
| Fax |
|
| Email |
smitamusti@gmail.com |
|
|
Source of Monetary or Material Support
|
| M S Ramaiah Medical College Bangalore 560054 |
|
|
Primary Sponsor
|
| Name |
M S Ramaiah Medical College |
| Address |
Department of Anaesthesia
M S Ramaiah Medical College
Bangalore 560054 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Geetha L |
Dr Geetha L
Department of Anaesthesia
MS Ramaiah Medical College
Bangalore 560054 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Smita Musti |
M S Ramaiah Medical College |
Department of Anaesthesia
M S Ramaiah Medical College
Bangalore
Bangalore
KARNATAKA |
9886125842
smitamusti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M S Ramaiah Medical College Ethics Committee |
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 |
| Comparator Agent |
caudal epidual block |
caudal epidural block |
| Comparator Agent |
erector spinae plane block |
bilateral ultrasound guided erector spinae plane block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All ASA grade 1-2 patients undergoing lumbar discectomy surgery. |
|
| ExclusionCriteria |
| Details |
ASA grade>3, Re exploration surgery, Coagulopathy, infection at local site |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess postoperative pain scores, time of first rescue analgesic demand, total dosage of rescue analgesic, time to ambulate |
postoperative time points 0hrs, 2hrs, 6hrs,12hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any adverse events observed |
48hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
22/06/2020 |
| Date of Study Completion (India) |
09/08/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The primary aim is to compare the analgesic efficacy of caudal epidural block and erector spinae plane block in patients undergoing lumbar discectomy surgery. Also the time duration needed to begin ambulation in the immediate postoperative period. Since erector spinae is newer block, we intend to look for any adverse events associated with it. We hypothesize that erector spinae plane block has better pain relief in adult patients when compared to caudal epidural block. |