| CTRI Number |
CTRI/2022/08/045117 [Registered on: 31/08/2022] Trial Registered Prospectively |
| Last Modified On: |
30/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison Between Efficacy Of Two Regional Anaesthetic Blocks for Early Postoperative Pain Relief In Patients Undergoing Spine Surgery |
|
Scientific Title of Study
|
Comparison Between Relative Efficacy Of Erector Spinae Plane Block And Caudal Epidural Injection For Early Postoperative Analgesia In Patients Undergoing Lumbar Spine Fusion Surgery - A prospective Randomized Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yogin Patel |
| Designation |
Orthopaedic surgeon |
| Affiliation |
Ganga Medical Centre And Hospital Pvt Ltd |
| Address |
Ganga Medical Centre And Hospital Pvt Ltd
313 Mettupalayam Road Saibaba Kovil Coimbatore
Department of Spine surgery
Research Room, B block, 7th floor
Ganga Medical Centre And Hospital Pvt Ltd
313 Mettupalayam Road Saibaba Kovil Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
7709538666 |
| Fax |
|
| Email |
dryoginpatel91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yogin Patel |
| Designation |
Orthopaedic surgeon |
| Affiliation |
Ganga Medical Centre And Hospital Pvt Ltd |
| Address |
Ganga Medical Centre And Hospital Pvt Ltd
313 Mettupalayam Road Saibaba Kovil Coimbatore
Department of Spine surgery
Research Room, B block, 7th floor
Ganga Medical Centre And Hospital Pvt Ltd
313 Mettupalayam Road Saibaba Kovil Coimbatore
Coimbatore
TAMIL NADU
641038
India |
| Phone |
7709538666 |
| Fax |
|
| Email |
dryoginpatel91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yogin Patel |
| Designation |
Orthopaedic surgeon |
| Affiliation |
Ganga Medical Centre And Hospital Pvt Ltd |
| Address |
Ganga Medical Centre And Hospital Pvt Ltd
313 Mettupalayam Road Saibaba Kovil Coimbatore
Department of Spine surgery
Research Room, B block, 7th floor
Ganga Medical Centre And Hospital Pvt Ltd
313 Mettupalayam Road Saibaba Kovil Coimbatore
Coimbatore
TAMIL NADU
641038
India |
| Phone |
7709538666 |
| Fax |
|
| Email |
dryoginpatel91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ganga Medical Centre And Hospital Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Ganga Medical Centre And Hospital Pvt Ltd |
| Address |
Ganga Medical Centre And Hospital Pvt Ltd
313 Mettupalayam Road Coimbatore |
| 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 |
| Yogin patel |
Ganga Medical Centre And Hospital Pvt Ltd |
Department of Spine surgery
Research Room, B block, 7th floor
Ganga Medical Centre And Hospital Pvt Ltd
Metttupalayam road Coimbatore
Coimbatore
TAMIL NADU |
7709538666
dryoginpatel91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M472||Other spondylosis with radiculopathy, (2) ICD-10 Condition: M480||Spinal stenosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Caudal Epidural Injection |
Caudal Epidural Injection
Route: Caudal Epidural route
Frequency: STAT dose (No repeat dose)
Duration: 6-8 Hours |
| Intervention |
Erector Spinae Plane Block |
Erector Spinae Plane Block
Route: Inter-fascial Plane Block
Frequency: STAT dose (No repeat dose)
Duration: 8-12 Hours |
| Comparator Agent |
No Block |
No Block |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Single Level Lumbar Fusion Surgery Patients |
|
| ExclusionCriteria |
| Details |
Spinal Infections tumor and trauma
Patients With Neurological Deficits
Previous Spine Surgery
Patients With Dural Tear |
|
|
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 |
Assessment Of NRS Score
|
To Assess Postoperative
Vas/Pain Score at 2hour, 4 hour, 8 hour, 12 hour, 24 hour. and 48 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Anti Emetic Requirement
PONV scale
Ramsey Sedation Scale
|
at 2, 4, 8, 12, 24 and 48 hours |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
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)
|
01/10/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Randomized Controlled study to Compare the relative efficacy of erector spinae plain block and caudal epidural injection for early post operative analgesia in patients undergoing single level lumbar fusion surgery. |