| CTRI Number |
CTRI/2020/10/028350 [Registered on: 12/10/2020] Trial Registered Prospectively |
| Last Modified On: |
09/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Study the effect of addition of clonidine to methylprednisolone in Selective Spinal Nerve Root Block For curing lower back pain |
|
Scientific Title of Study
|
To Study The Effect Of Addition Of Clonidine To Methylprednisolone In Selective Spinal Nerve Root Block |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raghav Singh Jaswal |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College And Hospital |
| Address |
Department of Anaesthesia and Critical Care, Indira Gandhi Medical College And Hospital, Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7018649802 |
| Fax |
|
| Email |
jaswal1698@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghav Singh Jaswal |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College And Hospital |
| Address |
Department of Anaesthesia and Critical Care, Indira Gandhi Medical College And Hospital, Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7018649802 |
| Fax |
|
| Email |
jaswal1698@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raghav Singh Jaswal |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College And Hospital |
| Address |
Department of Anaesthesia and Critical Care, Indira Gandhi Medical College And Hospital, Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7018649802 |
| Fax |
|
| Email |
jaswal1698@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Medical College And Hospital |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical College And Hospital |
| Address |
Department of Anaesthesiology And Critical Care, Indira Gandhi Medical College And Hospital, Shimla 171001 |
| 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 Ravikant Dogra |
Indira Gandhi Medical College And Hospital |
OT3, Department of Anaesthesia
Shimla
HIMACHAL PRADESH |
9418465978
drravikantdogra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IGMC Shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G578||Other specified mononeuropathies of lower limb, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clonidine |
Single shot of drug given (Group A- inj Methylprednisolone Aquous 40mg (1ml)+ inj bupivacaine 0.5% (0.5ml)+ inj Clonidine 15mcg (diluted to 1ml). Total volume 2.5ml. Group B-inj Methylprednisolone Aquous 40mg (1ml)+ inj bupivacaine 0.5% (0.5ml)+ Normal saline 1ml. Total Volume- 2.5ml). Patient discharged after 1 hour of observation in PACU. Follow up done at 1,2,3,4 weeks. Patient will be discharged from the pain clinic with routine antibiotic prophylaxis, NSAIDS in the form of Tablet Diclofenac 75 mg BD for 3 days and then as and when required (maximum administration explained) attached with department of physiotherapy. Patients will be advised to abstain from heavy workload after the procedure. Rescue analgesia in the form of Tab Tramadol 37.5mg and Tab Paracetamol 325 mg as and when required ((maximum administration explained) will be given. As most of these patients are already on gabapentin/ pregablin, these will be stopped post procedure and will be allowed to start in consultation with researchers. |
| Intervention |
Selective Spinal Nerve Root Block |
The procedure will be carried out with the patient in prone position. Intravenous sedation with Inj. Fentanyl at a dose of 1 microgram per kilogram body weight will be given before beginning the procedure maximum of 100 micrograms iv during the entire procedure.
• The fluoroscopic view is first optimized for the level of intended needle placement. This is also referred to as “squaring†the level, which basically places the x-ray beam perpendicular to the intended intervertebral level thereby squaring off the superior and inferior vertebral end plates.
• The view is then further optimized with an oblique angle so that the articular elements divide the intervertebral disc by one-third to two-thirds. The classic “Scottie dog†view.
• This view emphasizes the placement of the needle at the 6 o’clock position below the pedicle of the superior vertebra. The needle tip is then placed within the posterior-superior quadrant of the intervertebral foramen.
The area to be infiltrated will be cleaned and draped. Proper exposure to the site is given. Infiltration of the site with local anaesthetic is done. Using fluoroscopic guidance using C-arm with an image intensifier A 15cm 22G Quinckys spinal needle is advanced to the nerve root site. The position of the needle will be checked in both anteroposterior as well as lateral view. Radio opaque contrast (0.5-1ml) is injected to confirm the site of injection and to identify any intravascular spread of the injection. Single shot of drug given (Group A- inj Methylprednisolone Aquous 40mg (1ml)+ inj bupivacaine 0.5% (0.5ml)+ inj Clonidine 15mcg (diluted to 1ml). Total volume 2.5ml. Group B-inj Methylprednisolone Aquous 40mg (1ml)+ inj bupivacaine 0.5% (0.5ml)+ Normal saline 1ml. Total Volume- 2.5ml). Patient discharged after 1 hour of observation in PACU. Follow up done at 1,2,3,4 weeks. Patient will be discharged from the pain clinic with routine antibiotic prophylaxis, NSAIDS in the form of Tablet Diclofenac 75 mg BD for 3 days and then as and when required (maximum administration explained) attached with department of physiotherapy. Patients will be advised to abstain from heavy workload after the procedure. Rescue analgesia in the form of Tab Tramadol 37.5mg and Tab Paracetamol 325 mg as and when required ((maximum administration explained) will be given. As most of these patients are already on gabapentin/ pregablin, these will be stopped post procedure and will be allowed to start in consultation with researchers. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age groups 30 - 60 years of either sex, visiting the pain clinic for low back pain with associated radiculopathy of duration more than 2 weeks having already had failed medication and physiotherapy trial |
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. Age less than 18 years.
3. Bleeding tendencies.
4. Hypersensitivity
5. History of previous surgery in lumbar area.
6. Localised infection.
7. Patients with history of recent trauma to lumbar area.
8. Patients with paraplegia or paraparesis.
9. Untreated fractures of spine.
10. Patients with heart diseases.
11. Lower extremity weakness.
12. Allergy to Iodine contrast medium.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS Score |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Likert Scale
American Chronic Pain Association Quality Of Life Scale |
30 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
13/10/2020 |
| 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="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)?
|
|
Brief Summary
|
Injections in the spine are used in situations where surgery is not indicated for PIVD.These injections help in reduction of the pain, decrease patient symptoms, have long term pain relief, decrease use of frequent pain medication. Assesment of patients done on the basis of VAS score, Likert Scale, American Chronic Pain Association Quality of Life Scale. The purpose of the study is to see the effects of addition of clonidine to methylprednisolone in selective spinal nerve root block |