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CTRI Number  CTRI/2020/02/023131 [Registered on: 05/02/2020] Trial Registered Prospectively
Last Modified On: 22/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the convenience of ultrasound versus fluoroscopy guided caudal epidural block for low back pain with radiculopathy 
Scientific Title of Study   Feasibility of ultrasound versus fluoroscopy guided caudal epidural block for low back pain with radiculopathy: a randomised controlled 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 Shrey Goel 
Designation  Post Graduate Junior Resident 
Affiliation  Government Medical College and Hospital Sector 32 Chandigarh 
Address  Department of Anaesthesia and Intensive Care Government Medical College and Hospital Sector 32 Chandigarh Chandigarh CHANDIGARH 160030 India

Chandigarh
CHANDIGARH
160030
India 
Phone  8054383904  
Fax    
Email  shrey12goel@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sukanya Mitra  
Designation  Professor and Head 
Affiliation  Government Medical College and Hospital Sector 32 Chandigarh 
Address  Department of Anaesthesia and Intensive Care Government Medical College and Hospital Sector 32 Chandigarh Chandigarh CHANDIGARH 160030 India

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121521  
Fax    
Email  drsmitra12@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Shrey Goel 
Designation  Post Graduate Junior Resident 
Affiliation  Government Medical College and Hospital Sector 32 Chandigarh 
Address  Department of Anaesthesia and Intensive Care Government Medical College and Hospital Sector 32 Chandigarh Chandigarh CHANDIGARH 160030 India

Chandigarh
CHANDIGARH
160030
India 
Phone  8054383904  
Fax    
Email  shrey12goel@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College and Hospital, Sector 32, Chandigarh  
 
Primary Sponsor  
Name  Government Medical College and Hospital  
Address  Government Medical College and Hospital Sector 32 Chandigarh 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shrey goel  Government Medical College and Hospital  Pain operation theater, O.T complex C block,Department of anaesthesia and intensive care, sector 32 Chandigarh
Chandigarh
CHANDIGARH 		 8054383904

shrey12goel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE(GMCH CHANDIGARH)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fluoroscopy guided caudal epidural block  Group2, will receive injection 8ml of 0.25% bupivacaine with 80mg (2ml) of triamcinolone through caudal route under fluoroscopy guidance. 
Intervention  Ultrasound guided Caudal epidural block  Group 1, will receive injection 8ml of 0.25% bupivacaine with 80mg (2ml) of triamcinolone through caudal route under USG guidance.  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1) Patients attending the Pain Clinic of the Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, with chronic low back pain (LBP) of more than 3 months duration with bilateral radiculopathy, not responding to conservative treatment
2) Age 25- 80 years
3) American Society of Anaesthesiology (ASA)Physical status I or II
4) Magnetic resonance imaging (MRI) of lumbosacral spine findings of disc protrusion and disc bulge at various levels of lumbar spine and impingement of exiting and traversing nerve roots
 
 
ExclusionCriteria 
Details  1) Patients refusing to provide informed consent
2) Systemic infection or local infection at the site of injection
3) Bleeding diathesis or full anticoagulation
4) Significant allergic reaction/hypersensitivity to contrast, anaesthetic, or corticosteroid
5) Local malignancy
6) Patient refusal
7) Uncontrolled diabetes mellitus
8) Patients with severe cardiovascular, respiratory, renal, and hepatic diseases
9) Pregnancy (due to fluoroscopy)
10) Cases with severe motor weakness, rapidly progressing neurological deficit, cauda equina syndrome
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Time taken for correct placement of epidural needle, measured in seconds.  2nd, 4th, 8th, 12th week. 
 
Secondary Outcome  
Outcome  TimePoints 
NRS for pain (0-10) scores and ODI values 2nd, 4th, 8th, 12th week.  2nd, 4th, 8th, 12th week. 
 
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   Phase 4 
Date of First Enrollment (India)   01/09/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is a randomised, prospective,open labled trial. This study is planned to compare the efficacy and adverse effects of USG guided versus fluoroscopy guided caudal epidural block for LBP with radiculopathy. the aim of this study id to compare the analgesic efficacy of ultrasound versus fluoroscopy guided caudal epidural block for low back pain with radiculopathy.  The primary objective is to compare the correct time of epidural needle placement, with secondary objective of reduction of pain score by 0-10 Numeric Rating Scale (NRS), reduction of ODI and occurrence of adverse events if any at the end of 2nd, 4th, 8th, 12th week.    
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