| CTRI Number |
CTRI/2022/07/043660 [Registered on: 04/07/2022] Trial Registered Prospectively |
| Last Modified On: |
01/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [High volume Lumbar Erector Spinae Block versus transforaminal epidural steroidal injection] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In lowbackache and radicular pain patient, which one is more effective between transforaminal epidural steroid injection and high volume Lumbar erector spinae block |
|
Scientific Title of Study
|
Comparative study between Transforaminal Epidural Steroid Injection in patient versus High Volume Lumbar Erector Spinae Block in patient with Lowbackache and Radicular pain A Prospective Randomized Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rigved Arsh Singhrol |
| Designation |
Junior Resident |
| Affiliation |
IMS, BHU, Varanasi |
| Address |
Department of Anaesthesiology Institute of Medical Sciences,BHU varanasi
UTTAR PRADESH
221005
India
Anaesthesia dept,
IMS BHU,
Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9329847574 |
| Fax |
|
| Email |
singhrolrigved@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Anil Kumar Paswan |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Anaesthesiology,Institute of Medical Sciences BHU, Varanasi
Anaesthesia,
IMS , BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9794855871 |
| Fax |
|
| Email |
Dranil1973@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Anil Kumar Paswan |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Anaesthesiology,Institute of Medical Sciences BHU, Varanasi
Anaesthesia,
IMS,
BHU.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9794855871 |
| Fax |
|
| Email |
Dranil1973@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences,Banaras Hindu University, Varanasi-221005 |
|
|
Primary Sponsor
|
| Name |
IMS BHU |
| Address |
Department of Anaesthesiology,
Institute of Medical Sciences,Banaras HINDU University,Varanasi 221005 |
| Type of Sponsor |
Government medical college |
|
|
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 Rigved Arsh Singhrol |
Sir Sunderlal Hospital, Institue of Medical Sciences, Banaras Hindu University |
Department of anaesthesiology,Institute of Medical sciences(IMS),BHU Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH |
9329847574
singhrolrigved@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Institute of Medical Sciences,Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group ESP(E) |
Group (E)- 30ml of 0.25% Bupivacaine + Triamcinolone 20mg USG guided
(3 month) |
| Comparator Agent |
Group TFS(T) |
Group TFS(T)- 2.0ml of 0.25% Bupivacaine + Triamcinolone 20mg Fluoroscopy guided
(3 month) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA grade 1 and 2
2.Patient with low back ache with unilateral radicular pain persisting despite medical treatment |
|
| ExclusionCriteria |
| Details |
Patient refusal
Coagulation disorders
Allergic to Local Anesthetic agents
Presence of infection at injection area
Patient with previous history of spinal surgery
Patient with co morbidities
Spinal cord disease like scoliosis or mechanical instability like fracture
More than 2 level of disc hernia
Degenerated and sequestered disc |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain levels by Numeric rating scale (NRS) |
Immediately(With in 30 mins) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain level after intervention at 1 month , 3 month by Numeric rating scale.
Oswestry disability index
Patient requiring rescue Analgesia
Complications |
1 month and 3 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
04/07/2022 |
| 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
|
None Yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Low back pain is the leading cause of activity limitation and work absence throughout much of the world and is associated with an enormous economic burden. Lifetime prevalence of LBP is estimated to be >70% in industrialized countries. The purpose of the current study is to perform a relative credible and comprehensive assessment to compare the efficiency and safety of transforaminal epidural steroid injection Versus high volume lumber Erector spinae block in patient with low backache and radicular pain. The prospective study will be carried out on 60 adults patient which will be allocated into 2 groups containing 30 patient in each group. Patient with unilateral low backache with radicular pain persisting medical treatment were taken into study. After which randomisation was done and primary outcome was noted by numeric rating scale. Secondary outcome was also noted at 1month and 3 month. |