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CTRI Number  CTRI/2024/04/065591 [Registered on: 12/04/2024] Trial Registered Prospectively
Last Modified On: 26/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of sugar injection on breakdown of stuck nerves after surgery of lower back 
Scientific Title of Study   Effect of 10% dextrose as an adjuvant in lumbar epidural adhesiolysis : a prospective randomized controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhruv Jain 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  5011, Teaching Block, 5th Floor Department of Anaesthesiology, Pain Medicine and Critical Care AIIMS

South
DELHI
110029
India 
Phone  07042129423  
Fax    
Email  dhruvjn@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dhruv Jain 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  5011, Teaching Block, 5th Floor Department of Anaesthesiology, Pain Medicine and Critical Care AIIMS

South
DELHI
110029
India 
Phone  07042129423  
Fax    
Email  dhruvjn@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dhruv Jain 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  5011, Teaching Block, 5th Floor Department of Anaesthesiology, Pain Medicine and Critical Care AIIMS

South
DELHI
110029
India 
Phone  07042129423  
Fax    
Email  dhruvjn@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  AIIMS, New Delhi 
Address  Ansari Nagar, New Delhi 
Type of Sponsor  Research institution and hospital 
 
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 Dhruv Jain  All India Institute of Medical Sciences, New delhi  Pain OPD, 4th Floor, New RAK OPD, AIIMS
South
DELHI 
7042129423

dhruvjn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, New Delhi  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 
Comparator Agent  Epidural adhesiolysis and and steroid  Epidural adhesiolysis will be carried out with a Racz catheter by injecting hyaluronidase 1500 uits. 80 mg triamcinolone will be injected through the catheter into the epidural space 
Intervention  Epidural adhesiolysis and dextrose  Epidural adhesiolysis will be carried out with a Racz catheter by injecting hyaluronidase 1500 units. 10 ml of 10% dextrose will be injected through the catheter into the epidural space 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Low back with radicular pain more than 6 months with pain of 6 or more on 11 point NRS scale
2. Radicular pain present post lumbar spine surgery evident by MRI imaging and clinical examination
3. Failure to respond to conservative therapy and fluoroscopic guided epidural injections
4. Filling defects observed on contrast injection during previous epidural steroid injections 
 
ExclusionCriteria 
Details  1. Pain due to facet joint, sacroiliac joint or myofascial pain
2. Sequestered disc
3. Foraminal stenosis
4. Allergy to contrast or local anesthetics
5. Pregnant patients
6. Bleeding or coagulation disorders
7. Uncontrolled systemic disorders
8. Opioid addiction of psychiatric disorders
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
NRS for pain (on scale of 0-10)   Preprocedure
15 days, 1, 3 and 6 months post procedure  
 
Secondary Outcome  
Outcome  TimePoints 
Oswestry Disability Index score  Preprocedure
15 days, 1, 3 and 6 months post procedure 
Successful outcome  Preprocedure
15 days, 1, 3 and 6 months post procedure 
Reduction in medication usage  Preprocedure
15 days, 1, 3 and 6 months post procedure 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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/ Phase 3 
Date of First Enrollment (India)   29/04/2024 
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)
Modification(s)  
Not Yet Recruiting 
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  

Low back pain is a debilitating condition with a lifetime prevalence of 50-80% and results in severe biopsychosocial impact. Compression of nerves is common in low back pain leading to severe radicular pain and can be due to disc degeneration, spinal stenosis, inflammation and epidural adhesions. Post lumbar laminectomy syndrome or failed back surgery syndrome can affect up to 40% of patients and epidural fibrosis is thought to contribute to 60% of such cases . Adhesiolysis is a commonly performed procedure for such conditions which releases the nerve from entrapment. It is performed by a specialized spring coiled catheter (Racz catheter) which breaks the fibrous tissue my mechanical means and use of hyaluronidase. Epidural steroids are given afterwards to reduce inflammation, but may cause side effects like increases blood sugar levels, hypertension, water retention, lowering of immunity and infections. Dextrose is now being commonly employed for chronic pain conditions. The postulated mechanisms of dextrose in managing chronic pain include tissue regeneration, sensorineural effect, reduction of sensitization and hydrodissection All these factors may help in adhesiolysis procedure and attenuation of pain. We hypothesize that epidural administration of 10% dextrose would result in better pain relief than steroid after epidural adhesiolysis in patients with chronic lumbar radicular pain

 
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