| CTRI Number |
CTRI/2025/10/095815 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Pain Relief from two block injections namely Lateral Recess and Caudal Epidural Steroid Injection in Lumbar Disc Prolapse Patients |
|
Scientific Title of Study
|
To compare the analgesic efficacy of a single Lateral Recess steroid injection vs single Caudal epidural steroid injection in Lumbar disc prolapse patients with predominantly unilateral symptoms A randomized controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikhil Nair |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, Bhopal |
| Address |
Department of Anaesthesiology, All India Institute of Medical Sciences
Saket Nagar
Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9329934377 |
| Fax |
|
| Email |
nikhilnair.2399@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nikhil Nair |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, Bhopal |
| Address |
Department of Anaesthesiology, All India Institute of Medical Sciences
Saket Nagar
Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9329934377 |
| Fax |
|
| Email |
nikhilnair.2399@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikhil Nair |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, Bhopal |
| Address |
Department of Anaesthesiology, All India Institute of Medical Sciences Bhopal
Saket Nagar
Bhopal, Madhya Pradesh
India
Pin 462 020
P G boys Hostel, All India Institute of Medical Sciences Bhopal
Saket Nagar
Bhopal, Madhya Pradesh
India
Pin 462 020
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9329934377 |
| Fax |
|
| Email |
nikhilnair.2399@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Saket nagar, Bhopal, Madhya Pradesh, India pin 462020 |
|
|
Primary Sponsor
|
| Name |
Dr Anuj Jain |
| Address |
Department of Anaesthesiology, All India Institute of Medical Sciences Bhopal
Saket Nagar
Bhopal, Madhya Pradesh
India
Pin 462 020 |
| Type of Sponsor |
Other [Additional Professor] |
|
|
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 Nikhil Nair |
All India Institute of Medical Sciences, Bhopal |
Ot 10, Modular OT 2nd floor, All India Institute of Medical Sciences Bhopal
Saket Nagar
Bhopal, Madhya Pradesh
India
Pin 462 020
Bhopal
MADHYA PRADESH |
9329934377
nikhilnair.2399@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, Bhopal Institutional Human Ethics Committee- Student Research (IHEC-SR) |
Approved |
|
|
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 |
| Comparator Agent |
Caudal epidural steroid injection |
Caudal epidural steroid injection (CESI) is a widely practiced interventional technique for the management of lumbar radiculopathy and low back pain. It involves introducing corticosteroids, often combined with local anesthetics, into the epidural space through the sacral hiatus. This approach allows the injected medication to spread cranially within the epidural space, bathing multiple lumbosacral nerve roots simultaneously. The anti-inflammatory effects of corticosteroids reduce perineural inflammation, edema, and pain transmission, while the anesthetic provides short-term analgesia. CESI is technically simpler, associated with a relatively low risk of dural puncture or neurological injury, and can be safely performed even in patients with altered spinal anatomy. It is particularly useful in cases with diffuse, bilateral, or multilevel radicular symptoms. However, its drug delivery is less targeted compared to selective injections, sometimes resulting in reduced efficacy in focal unilateral radiculopathy. Despite this, CESI remains a practical, minimally invasive, and effective option for lumbar disc-related pain. Dosage given
40 mg triamcinolone
10 ml of 0.125% bupivacaine or 1% lidocaine
Total volume: usually 10–15 ml, depending on desired epidural spread. This is given once and typically the procedure takes around 15 to 20 minutes.
|
| Intervention |
Lateral Recess Steroid injection |
Lateral recess steroid injection (LRSI) is an image-guided interventional technique used for managing lumbar disc prolapse presenting with unilateral radicular pain. Unlike caudal or interlaminar epidural injections, LRSI specifically targets the lateral recess of the spinal canal, where nerve root compression commonly occurs. By delivering corticosteroids directly to the site of inflammation, LRSI reduces perineural edema, suppresses inflammatory mediators, and alleviates neuropathic pain. The use of fluoroscopic or CT guidance enhances precision, ensuring optimal placement of the drug while minimizing systemic exposure and procedural complications. Clinical studies have demonstrated that LRSI provides significant improvements in pain relief, functional capacity, and quality of life, often outperforming more generalized epidural approaches in cases of unilateral paracentral disc herniation. As a focused, minimally invasive intervention, LRSI offers a valuable therapeutic option when conservative measures fail, serving as a bridge between non-invasive treatments and surgical management in lumbar radiculopathy. dosage of drug Corticosteroid: Triamcinolone acetonide 40 mg
Local anaesthetic: 0.5–1 ml of 0.125% bupivacaine
The total volume injected is typically 2–3 ml, depending on the patients anatomy and response. this is done once during the intervention and usually takes around 20 - 30 minutes.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: Adults aged between 18 and 60 years.
2. Clinical Presentation: Unilateral radicular pain corresponding to a specific nerve root distribution, persisting for more than 3 months.
3. Imaging Confirmation: MRI evidence of lumbar disc herniation at L4-L5 or L5-S1 levels, causing nerve root compression.
4. Treatment History: Symptoms refractory to at least 6 weeks of conservative management, including physical therapy and pharmacological treatment.
5. Functional Status: Baseline Oswestry Disability Index (ODI) score indicating moderate to severe disability.
|
|
| ExclusionCriteria |
| Details |
1. Previous Lumbar Surgery: History of lumbar spine surgery at the affected level.
2. Neurological Deficits: Presence of severe motor weakness, rapidly progressing neurological symptoms, or signs of cauda equina syndrome.
3. Systemic Conditions: Uncontrolled diabetes mellitus, bleeding disorders, or active infections.
4. Medication Use: Use of systemic corticosteroids within the past 3 weeks.
5. Allergies: Known hypersensitivity to steroids, local anaesthetics, or contrast agents used in the procedures.
6. Pregnancy: Pregnant or lactating women.
7. Other Spinal Pathologies: Presence of spinal tumors, infections, or other non-discogenic causes of radiculopathy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Improvement in the two groups receiving the interventions on the Oswestry Disability Index (ODI) |
At baseline, 4 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in 6 Minute Walk distance at weekly interval for 3month after the procedure using a mobile app |
At baseline, 1 week, 2 week, 3 week, 4 week, 5 week, 6 week, 7 week, 8 week, 9 week, 10 week, 11 week, 12 week interval |
| Improvement in quality of life using Short Form Health Survey (SF-12) score. |
At baseline, 4 week & 12 week interval |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
26/10/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is a prospective, randomized, double-blind controlled trial conducted at AIIMS Bhopal to compare the analgesic efficacy of lateral recess steroid injection (LRSI) and caudal epidural steroid injection (CESI) in patients with lumbar disc prolapse presenting predominantly with unilateral symptoms. A total of 100 adults aged 18–60 years, with MRI-confirmed L4–L5 or L5–S1 disc herniation and unilateral radicular pain persisting for more than three months despite at least six weeks of conservative therapy, will be enrolled. Patients with prior lumbar surgery, severe neurological deficits, cauda equina, uncontrolled systemic illness, pregnancy, or steroid allergy are excluded. Participants will be randomized into two groups: the LRSI group receiving triamcinolone 40 mg with 0.5–1 ml of 0.125% bupivacaine (total 2–3 ml), and the CESI group receiving triamcinolone 40 mg with 10 ml of 0.125% bupivacaine (total 10 ml), both under fluoroscopic guidance. The primary outcome is improvement in disability assessed by the Oswestry Disability Index (ODI). Secondary outcomes include six-minute walk distance recorded weekly via a mobile app, SF-12 quality-of-life scores, and time to recurrence of pre-procedure symptoms. Patients will be followed up at baseline, one month, and three months. The trial aims to generate high-quality evidence to guide clinicians in selecting the most effective interventional strategy for unilateral lumbar disc prolapse. |