| CTRI Number |
CTRI/2023/10/059336 [Registered on: 31/10/2023] Trial Registered Prospectively |
| Last Modified On: |
26/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of the analgesic efficacy of ultrasound guided two nerve blocks in patients with chronic neck pain. |
|
Scientific Title of Study
|
Comparison of Clinical efficacy of Ultrasound guided
Selective Nerve Root Block versus Ultrasound guided Retro-
Laminar Cervical block in Patients with Cervical
radiculopathy- A randomized control 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 |
Siddani Jaya Sai Satya Sivani |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduation and Medical Education and Research |
| Address |
Department of Anaesthesiology and Critical care,
JIPMER,
Dhanvanthri nagar,
PONDICHERRY.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7680820646 |
| Fax |
|
| Email |
satyasivanisiddani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Adinarayan S |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal Institute of Postgraduation and Medical Education and Research |
| Address |
Department of Anaesthesiology and Critical care,
JIPMER,
Dhanvanthri nagar,
PONDICHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442396762 |
| Fax |
|
| Email |
adinarayanans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Adinaryanan S |
| Designation |
Additional Profesor |
| Affiliation |
Jawaharlal Institute of Postgraduation and Medical Education and Research |
| Address |
Department of Anaesthesiology and Critical care,
JIPMER,
Dhanvanthri nagar,
PONDICHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
944239762 |
| Fax |
|
| Email |
adinarayanans@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of postgraduate and Medical Education and Research, Gorimedu, Pondicherry, 605006. |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate and Medical Research |
| Address |
Jipmer campus Road,
Jipmer campus,
Dhanvanthri Nagar,
Puducherry,
605006. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Siddani Jaya Sai Satya Sivani |
Jawaharlal Institute of Postgraduate Medical Education and Research |
2nd floor, Institute block,Department of Anaesthesiology and Critical care.
Pondicherry
PONDICHERRY |
7680820646
satyasivanisiddani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER Institutional Ethics Committee Interventional Studies |
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 |
NIL |
NIL |
| Intervention |
Ultrasound guided Retrolaminar Cervical block |
The patients in the USG guided Retrolaminar Cervical Block will be receiving 3ml of lignocaine 2% and 2ml of Dexamethasone of 8mg, total of 5ml. The corresponding nerve root where the block to be given will be decided pre procedure using clinical findings and MRI findings. During the procedure, the nerve root level to be blocked will be identified with the help of ultrasound imaging in a parasagittal oblique view , lamina will be identified and using 22G 10cm Echoplex neeedle with inplane approach, the drug will be deposited at the posterior aspect of the lamina. Color Doppler wil be used to identify any surrounding vessels. Pre intervention and post intervention VAS score, Neck Disability Index score, pain free days, quality of life using SF-12 questionnaire will be assessed on Day0,1,7,14,30,month 2,3 and 6. |
| Intervention |
Ultrasound guided Selective Nerve Root block |
The patients in the USG guided Selective Nerve Root Block will be receiving 2ml of lignocaine 2% and 2ml of Dexamethasone of 8mg, total of 4ml at the corresponding nerve root.
The corresponding nerve root where the block to be given will be decided pre procedure using clinical findings and MRI findings. During the procedure, the nerve root to be blocked will be identified with the help of ultrasound imaging and using 22G 10cm Echoplex neeedle with inplane approach, the drug will be deposited at the dorsal aspect of the nerve where it exits the intervertebral foramen. color doppler will be used to identify any surrounding vessels.
Pre intervention and post intervention VAS score, Neck Disability Index score, pain free days, quality of life using SF-12 questionnaire will be assessed on Day0,1,7,14,30,month 2,3 and 6. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Consenting Patients having Cervicogenic neck pain with etiology of either cervical disc herniation or cervical stenosis for more than 3 months with VAS score of greater than 6 despite conservative management. |
|
| ExclusionCriteria |
| Details |
1.Cardiopulmonary disease
2. Severe cervical stenosis who requires surgical management
3. Patients withPrimary shoulder pathology, neurological deficits, Cervical Myelopathyor cervical nerve root compression other than disc herniation including tumor or stenosis.
4. Those with previous spine surgeries or previous epidural steroid within 3 months duration.
5. Bleeding disorders
6.Allergy to study drugs
7. Local infection
8. Cervical radiculopathy having motor symptoms
9. Psychiatric disorders.
10. Lab results suggestive of Inflammatory disease or rheumatoid arthritis.
11. Pregnancy/lactation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Numerical Rating Scale(NRS) score among the patients receiving Ultrasound guided Selective Nerve Root Block Versus Ultrasound guided Retrolaminar Cervical Block in patients with Cervical Radiculopathy. |
Pre intervention
Post intervention day 0
Post intervention day 1
Post intervention day 7
Post intervention week 2
Post intervention month 1
Post intervention month 3
Post intervention month 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neck disability Index(NDI) |
Pre intervention
Post intervention day 0
Post intervention day 1
Post intervention day 7
Post intervention week 2
Post intervention month 1
Post intervention month 3
Post intervention month 6 |
| Quality of Life using the 12 item short form survey (SF-12) |
Pre intervention
Post intervention day 0
Post intervention day 1
Post intervention day 7
Post intervention week 2
Post intervention month 1
Post intervention month 3
Post intervention month 6 |
| Pain free days(using Calender method) |
Pre intervention
Post intervention day 0
Post intervention day 1
Post intervention day 7
Post intervention week 2
Post intervention month 1
Post intervention month 3
Post intervention month 6 |
1.Duration and Ease of administration.
2.Adverse events related to the block such as Intravascular, Intraneural injection will be noted
|
During intervention |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2023 |
| 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)
|
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)?
Response - NO
|
|
Brief Summary
|
Cervical radiculopathy is a common condition that usually results from compression and inflammation of the cervical nerve root or roots in the region of the neural
foramen. The clinical manifestations are broad and may include pain, sensory deficits, motor deficits, diminished reflexes, or any combination of the above. Non
operative treatment of cervical radiculopathy consists of a number of different modalities including immobilization, physical therapy, traction, manipulation,
medication, and cervical steroid injection. Cervical Epidural Steroids Injection are being used in patients with less improvements with non-invasive conservative therapies. Most commonly used Epidural
steroid injections are Fluoroscopic guided Transforaminal Epidural Steroid Injections and Fluoroscopic guided Inter Laminar Epidural Steroid Injections. Studies
comparing Fluoroscopic guided techniques and Ultrasound guided Selective Nerve Root block found no statistically significant difference in clinical
efficacy. Ultrasound guided Selective Nerve Root Block is associated with less intravascular injection rate and similar pain relief. Real time Ultrasound guidance helps in Identification of critical vessels at unexpected locations relative to the Intervertebral foramen and avoiding injury
to such vessels, Better identification of anatomical structures, Real time visualization of drug spread and Shorter duration of procedure. It also has no
Radiation exposure and functional improvements compared to Fluoroscopic guided Epidural Steroid Injections. The Ultrasound guided Retrolaminar Cervical Block has shown promising results in reduction of Cervical radicular pain and it may be considered safer than
Epidural Steroid Injections as it does not require entering into the neuraxis. There are no available RCTs, in literature, that have compared the effects of these two modalities among Indian population. In our study, we propose to find the
difference and compare the clinical efficacy and adverse effects of Ultrasound guided Selective Nerve Root Block versus Ultrasound guided Retrolaminar Cervical
block in patients with Chronic Cervical Radiculopathy. The results of this study will help us to choose an ideal intervention technique for patients with Chronic
Cervical radiculopathy. |