| 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
|
|
|
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
|
|
|
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. |