| CTRI Number |
CTRI/2021/01/030167 [Registered on: 01/01/2021] Trial Registered Prospectively |
| Last Modified On: |
29/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative evaluation of two different approaches for lumbar transforaminal epidural injection in patients with lumbar radiculopathy |
|
Scientific Title of Study
|
A comparative evaluation of Kambins triangle approach versus Safe triangle approach for lumbar transforaminal epidural injection in patients with lumbar radiculopathy - A prospective, randomised, double blind study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajasree Biswas |
| Designation |
Associate Professor |
| Affiliation |
RG Kar MCH |
| Address |
Dept.: Anaesthesiology and pain management
RG Kar Medical College and Hospital
Kolkata
Dept.: Anaesthesiology and pain management
RG Kar MCH
KOlkata 700004
Kolkata
WEST BENGAL
700004
India |
| Phone |
9433875954 |
| Fax |
|
| Email |
docrajasree@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajasree Biswas |
| Designation |
Associate Professor |
| Affiliation |
RG Kar MCH |
| Address |
Department of anaesthesilogy
Division: Pain management
RG Kar Medical College and Hospital
Kolkata 700004
Department of anaesthesilogy
Division: Pain managementRG Kar MCH
KOlkata 700004
Kolkata
WEST BENGAL
700004
India |
| Phone |
9433875954 |
| Fax |
|
| Email |
docrajasree@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajasree Biswas |
| Designation |
Associate Professor |
| Affiliation |
RG Kar MCH |
| Address |
Department of anaesthesilogy
Division: Pain management
RG Kar Medical College and Hospital
Kolkata 700004
Department of anaesthesilogy
Division: Pain management
RG Kar MCH
KOlkata 700004
Kolkata
WEST BENGAL
700004
India |
| Phone |
9433875954 |
| Fax |
|
| Email |
docrajasree@gmail.com |
|
|
Source of Monetary or Material Support
|
| RG Kar Medical College and Hospital
Dist.:Kolkata
Pin: 700004 |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Nil] |
|
|
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 Rajasree Biswas |
RG Kar MCH |
Dept. of Anaesthesiology and Pain management;
KOlkata,
Pin: 700004
Kolkata
WEST BENGAL |
9433875954
docrajasree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RG Kar Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G549||Nerve root and plexus disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
kambins triangle approach for lumbar transforaminal epidural injection |
kambins triangle approach for lumbar transforaminal epidural injection |
| Comparator Agent |
safe triangle approach for lumbar transforaminal epidural injection
|
safe triangle approach for lumbar transforaminal epidural injection
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Lumbar radiculopathy
2. ASA I, II, III
3. Scheduled for transforaminal epidural injection
|
|
| ExclusionCriteria |
| Details |
Severe uncontrolled diabetes mellitus, hypertension
Patients on steroid Coagulopathy
Previous knee exploration
• ASA IV
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE FLUOROSCOPY GUIDED SUBPEDICULAR APPROACH AND THE APPROACH USING KAMBINS TRIANGLE IN TRANSFORAMINAL EPIDURAL INJECTION PERFORMED IN PATIENTS WITH SPINAL STENOSIS COMPLAINING OF LUMBAR RADICULAR PAIN in terms of pain relief and functional improvement |
1st January, 2021 to 30th June, 2021 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to investigate and compare the intra procedure complications and post procedure side effects for both the approach. |
01.01.2020 to 30.06.2020 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
·
Lumbar radiculopathy affects
significant number of patients causing severe neurogenic pain. Transforaminal
epidural injection of local anaesthetic and steroid is an effective treatment
for this condition. Subpedicular approach is usually used for transforaminal
epidural injection but has the risk of nerve and vessel injury. Kambin described
the kambin’s triangle, approach through which can lead to less chance of neurovascular
injury. Aim of our study is to compare these two approaches and any
complication during procedure and post procedure pain relief and any
complication . |