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CTRI Number  CTRI/2025/03/081699 [Registered on: 05/03/2025] Trial Registered Prospectively
Last Modified On: 20/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Lumbar Triamcinolone will be compared with lumbar Dexamethasone to assess pain relief in patients with PIVD 
Scientific Title of Study   To study the effectiveness of lumbar epidural dexamethasone with bupivacaine versus triamcinolone with bupivacaine in patients with prolapsed intervertebral disc 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhimanyu Dehal 
Designation  Junior Resident 
Affiliation  Department of Anaesthesiology MMCH Solan 
Address  Department of Anaesthesiology Third floor MAHARISHI MARKANDESHWAR MEDICAL COLLEGE AND HOSPITAL KUMARHATTI
Department of Anaesthesiology Third floor MAHARISHI MARKANDESHWAR MEDICAL COLLEGE AND HOSPITAL KUMARHATTI
Solan
HIMACHAL PRADESH
173229
India 
Phone  8219874464  
Fax    
Email  meabhimanyu.00@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Smriti Anand 
Designation  Professor 
Affiliation  Maharishi Markandeshwar Medical College and Hospital, Kumarhatti 
Address  Department of Anaesthesiology Third floor MAHARISHI MARKANDESHWAR MEDICAL COLLEGE AND HOSPITAL KUMARHATTI

Solan
HIMACHAL PRADESH
173229
India 
Phone  9418079103  
Fax    
Email  gupta.smriti1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Smriti Anand 
Designation  Professor 
Affiliation  Maharishi Markandeshwar Medical College and Hospital, Kumarhatti 
Address  Department of Anaesthesiology Third floor MAHARISHI MARKANDESHWAR MEDICAL COLLEGE AND HOSPITAL KUMARHATTI


HIMACHAL PRADESH
173229
India 
Phone  9418079103  
Fax    
Email  gupta.smriti1@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Maharishi Markandeshwar Medical college and hospital, Kumarhatti, Solan 
 
Primary Sponsor  
Name  Dr Abhimanyu Dehal 
Address  Department of Anaesthesia, Third floor, Maharishi Markandeshwar Medical college and hospital, Kumarhatti, Solan. 
Type of Sponsor  Private 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 Abhimanyu Dehal  Maharishi Markandeshwar Medical college and hospital, Kumarhatti, Solan  OT Complex, third floor, 301, Department of Anaesthesia, Maharishi Markandeshwar Medical college and hospital, Kumarhatti, Solan, Himachal Pradesh, PIN 173229
Solan
HIMACHAL PRADESH 
8219874464

meabhimanyu.00@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maharishi Markandeshwar Medical college and Hospital, Kumarhatti, Solan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BUPIVACAINE WITH DEXAMETHASONE   8mg Dexamethasone+ 0.125% Bupivacaine with Normal saline, total 10ml drug volume is given as lumbar epidural analgesia. 
Comparator Agent  BUPIVACAINE WITH DEXAMETHASONE AND BUPIVACAINE WITH TRIAMCINOLONE   Pain will be assessed on subsequent time intervals using VAS. 
Intervention  BUPIVACAINE WITH TRIAMCINOLONE   40mg Triamcinolone+ 0.125% Bupivacaine with normal saline, total10ml drug volume is given as lumbar epidural analgesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Individuals aged 18-70 years
2.Failed conservative treatment of PIVD for over 6 weeks
3. Chronic lumbar radiculopathy
4. Radiographic imaging (such as CT-scan or MRI) indicating the presence of either a herniated disc causing irritation or compression of a nerve root. 
 
ExclusionCriteria 
Details 
1. Contraindications to the procedure itself, including active, local, or systemic infection, unstable medical conditions, coagulopathy, or the use of anti-thrombotic or anti-platelet medication, excluding aspirin, and allergy to contrast medium or injected medication.
2. Presence of cauda equina syndrome.
3. Back and lower extremity pain attributed to tumour origin, infections, or inflammatory pathologies of back.
4. History of prior low back surgery.
5. Pregnancy or nursing. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To systematically evaluate and compare the therapeutic effectiveness of lumbar epidural route injections containing dexamethasone versus triamcinolone in managing pain and enhancing functional outcomes in patients diagnosed with prolapsed intervertebral disc.  results will enable us to assess and contrast the proportion of patients experiencing over 50% pain relief at designated follow-up time points of 1 hour, 24 hours, 15 days, 1 month and 3 month utilizing the VAS (Visual Analog Scale) Score. 
 
Secondary Outcome  
Outcome  TimePoints 
Compare particulate steroids versus non particulate steroid for pain relief, and duration of Pain Relief.  Successful treatment outcome will be considered in patients with 50% reduction in VAS score from baseline after 3 months. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 2 
Date of First Enrollment (India)   20/03/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
A prolapsed intervertebral disc in the spine is a condition during which a nucleus pulposus is displaced from intervertebral space. It is a common cause of back pain.
Several nonsurgical medical treatments have been proposed for lumbosacral radicular pain, from lifestyle changes, exercise and physical therapy to analgesic local/oral drugs and epidural steroid injections (ESIs).
An ESI is a common and minimally invasive procedure, performed to successfully treat lumbosacral radicular pain, which has also proved its effectiveness in the treatment of acute back pain and leg symptoms. The injections are used to deliver steroids, and sometimes local anaesthetics, to the epidural space, directly to the site that causes the pain using a caudal, interlaminar route. The preparation of steroids used in the epidural space can be divided into 2 groups particulate such as methylprednisolone, betamethasone, and triamcinolone; and non- particulate like dexamethasone phosphate. Corticosteroids decrease inflammation through inhibition of prostaglandins in the arachidonic acid cascade, which may improve microcirculation through decreasing capillary permeability, nerve root oedema, and ischemia.Steroids also directly inhibit the excitation of pain-generating c-fibre neurons.Various steroid preparations are utilized for Epidural Steroid Injections (ESIs), including dexamethasone, triamcinolone, betamethasone, and methylprednisolone along with local anesthetics. The Aim of our study is to systematically evaluate and compare the therapeutic effectiveness of lumbar epidural injections containing dexamethasone versus triamcinolone in managing pain and enhancing functional outcomes in patients diagnosed with prolapsed intervertebral disc, contributing valuable insights to optimize treatment approaches for this common spinal condition.


 
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