| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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 |
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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
|
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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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