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CTRI Number  CTRI/2024/06/068775 [Registered on: 12/06/2024] Trial Registered Prospectively
Last Modified On: 18/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of analgesic effectiveness of transforaminal epidural steroid injection versus steroid with ketamine in patients with lower back pain 
Scientific Title of Study   Comparison of analgesic efficacy of transforaminal epidural steroid versus steroid with ketamine in patients with lumbosacral radiculopathy - 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  Dr Aditi Awasthi 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anaesthesiology and critical care, JIPMER, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9418975656  
Fax    
Email  awasthi.aditi16@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S Adinarayanan 
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anaesthesiology and critical care, JIPMER, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9442396762  
Fax    
Email  adinarayanans@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr S Adinarayanan 
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anaesthesiology and critical care, JIPMER, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9442396762  
Fax    
Email  adinarayanans@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantari Nagar, Puducherry, 605006, India 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical education and Research 
Address  Jawaharlal Institute of Postgraduate Medical education and Research, Puducherry, 605006 
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 Aditi Awasthi  Jawaharlal institute of postgraduate medical education and research, Puducherry  Department of Anaesthesiology and critical care, room no 30, 2nd floor, Institute Block, Jawaharlal institute of postgraduate medical education and research, Dhanvantari Nagar, Gorimedu, Pondicherry 605006
Pondicherry
PONDICHERRY 
9418975656

awasthi.aditi16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jawaharlal Institute of Postgraduate Medical Education and Research, Institutional Ethics Committee- Interventional Studies  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  Transforaminal epidural steroid (group SN)  In patients with lumbosacral radiculoapthy we will give transforaminal epidural injection with steroid. In this group patient will recieve 6ml of study drug comprising of 0.5% bupivacaine (3ml) with 40mg triamcinolone (1ml) and 0.9% normal saline (2ml).  
Intervention  Transforaminal epidural steroid plus ketamine (group SK)  In patients with lumbosacral radiculopathy we will give transforaminal epidural injection with steroid plus ketamine. In this group Patient will receive 6ml of study drug comprising 0.5% bupivacaine (3ml) with 40mg triamcinolone (1ml) and injection ketamine preservative free 30mg (0.6ml)and 0.9% normal saline (1.4ml).  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ASA 1-2 patients with chronic low back pain, patients with no symptomatic relief from conservative treatment 
 
ExclusionCriteria 
Details  Patients with spinal cord deformities, previous history of spine surgery, uncontrolled Diabetes, Hypertension, B/L side pain, History of allergy to local anaesthetics, Bleeding disorders, Psychiatric disorders, Pregnancy/lactation 
 
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 compare the analgesic efficacy in both the groups using Visual Analogue scale(VAS) score at 2 weeks  2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Oswestry Disability Index (ODI)  24 hr, 2 week, 1st month, 2nd month, 3rd month 
Medication Quantification Scale(MQS)  24 hr, 2 week, 1st month, 2nd month, 3rd month  
Total duration of analgesia  3 month 
Requirement of repeat block in both the groups during three month period  3 month 
Any adverse event  within 3 months study duration 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   18/06/2024 
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 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   Lumbosacral Radiculopathy is term used to describe the pain syndrome caused by compression or irritation of nerve roots in the lower back. It can be caused by disc herniation, degeneration of spinal vertebra, and narrowing of neural foramen. Clinical manifestations include lower back pain thatradiates to lower extremities in a dermatomal pattern, numbness, weakness, loss of reflexes. Treatment options includes conservative medical management and non pharmacological which includes physical therapy, accupunture, chiropractic manipulation etc. Nowadays interventional techniques are commonly used to treat lower back pain reducing the need for surgical interventional. Transforaminal epidural steroid injection is one such interventional technique commonly used, addition of adjuvants to these epidural steroid injections like Ketamine has shown promising results by providing better clinical outcome and reducing frequency of repeated blocks.
In our study we are comparing the analgesic efficacy of transforaminal epidural steroid injection to that  of addition of Ketamine to steroid in patients with lumbosacral radiculopathy. In our study we are expecting that addition of ketamine to steroid in transforaminal epidural steroid injection will provide a longer duration of analgesia and pain free period than administering steroid alone.    

The patients will be randomly allocated into any of the 2 groups based on a computer-generated block random number table and allocation into the groups will be concealed by the Serially Numbered Opaque Sealed Envelopes (SNOSE) technique. Two groups studied in this trial include Group SN (receives transforaminal epidural steroid injections), Group SK (receives transforaminal epidural steroid plus ketamine).

 Intravenous cannula will be secured, a lignocaine test dose will be given, and the patient will be shifted to the operation theatre. In the operation theatre, the patient will be positioned prone on the table with a pillow between the lower abdomen and iliac crest to reduce lumbar lordosis. All ASA (American Society of Anesthesiologists) standard monitors will be attached which includes pulse oximetry, non-invasive blood pressure and electrocardiogram. Under sterile precautions, parts will be cleaned and draped. The level and the side to be blocked will be marked and confirmed again. Level identification will be done using sequential fluoroscopic images. The true anteroposterior image will be obtained by appropriate cephalo-caudal tilt, followed by same-side (pathology side) oblique tilt to obtain the Scotty dog appearance. At the appropriate lumbar-sacral spine level (L1-S1), local infiltration with 1% lignocaine will be given in the 6 o’clock position to the pedicle on the same side. The tip of a 23-gauge, Quincke’s spinal needle will be gradually advanced from the 6 o’clock direction, towards the target inferior to the pedicle under radiologic guidance. During the procedure, the lateral view will be obtained, and the needle will advance in the anterior and superior direction of the neural foramen. Optimal needle placement for injection into the anterior epidural space is confirmed by injecting a small volume of radio contrast media under intermittent fluoroscopic imaging. The contrast material (Iohexol Contrapaque®350, 350mg/ml) 1ml will be injected to confirm the transforaminal spread along the desired nerve root and also to rule out intravascular injection under fluoroscopic guidance. Drug with a volume of 6 ml will be injected in the respective nerve root depending on the group patient belongs to. In Group SN: The Patient will receive 6 ml of study drug comprises of 0.5% bupivacaine (3 ml) with 40 mg triamcinolone (1ml) and 0.9% normal saline 2ml and in Group SK: The patient will receive 6ml of study drug comprising of 0.5% bupivacaine (3ml) with 40 mg triamcinolone (1ml) and injection ketamine preservative-free 30 mg (0.6ml) and 0.9% normal saline (1.4ml). Vitals will be monitored every 1 minute for 5 minutes on the operating table after taking the patient to a supine position. Then the patient will be shifted to the pain ward and all ASA standard monitoring will be done every 5 minutes for 30 minutes and then every hour for 3-4 hours. For both groups, following initial interventions, the patients will be advised to perform rehabilitation exercises for strengthening the back muscles based on a homogenized physiotherapy protocol. All patients will be evaluated for the reduction in the VAS score at rest and movement 30 minutes immediately following post-procedure and at 4 hours (pain ward), 24 hours, 2nd week and every month for the 1st 3 months. Oswestry Disability index, and Medication Quantification Scale (MQS) will be noted at baseline, 24 hrs, 2nd week and every month for the 1st 3 months. All patients will be advised for a tablet paracetamol 500 mg thrice daily and a tablet Tramadol 50 mg SOS and the analgesic requirements in both the groups will be noted. Any patient presenting post procedure with moderate to severe VAS score >4 after two months, repeat block will be considered and noted. In case if patient is not having more than 50% reduction in VAS score from baseline, it will be considered as block failure. In case of failure rescue analgesics Tab. Tramadol 50 mg thrice daily, Tab. Paracetamol 500 mg thrice daily will be continued.

 
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