| CTRI Number |
CTRI/2025/06/088045 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
30/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Cervical pain block for pain management |
|
Scientific Title of Study
|
To study and compare analgesic efficacy and safety of Ultrasound guided Transforaminal cervical nerve root block (CNRB) versus High Thoracic erector spinae plane block ( ESPB) in patients with lower cervical pain : 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 |
Palvi |
| Designation |
Junior Resident |
| Affiliation |
Department of Anesthesia Dr Rajender Prasad Government medical college Tanda Kangra Himachal Pradesh |
| Address |
Room number 101 operation theater complex 3rd floor Department of Anesthesia Dr Rajender Prasad Government medical college Tanda Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9805251059 |
| Fax |
|
| Email |
negipallaavi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharti Sood Gupta |
| Designation |
Associate Professor Department of Anesthesia Dr Rajender Prasad government medical college Tanda Kangra Himachal Pradesh |
| Affiliation |
Dr Rajender Prasad government medical college Tanda Kangra Himachal Pradesh |
| Address |
Room 104 Operation Theater complex 2nd floor Department of Anesthesia Dr Rajender Prasad government medical college Tanda Kangra Himachal Pradesh
176001 India
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418044928 |
| Fax |
|
| Email |
drbharti203@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Palvi |
| Designation |
Junior resident |
| Affiliation |
Dr Rajender Prasad government medical college Tanda Kangra Himachal Pradesh |
| Address |
Room number 101 operation theater complex 3rd floor Department of Anesthesia Dr Rajender Prasad government medical college Tanda Kangra Himachal Pradesh
176001- India
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9805251059 |
| Fax |
|
| Email |
negipallaavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical Superintendent Office Room No 203 First floor (Block A) Dr Rajender Prasad government medical college Tanda Kangra Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Palvi |
| Address |
Department of Anaesthesia Dr RPGMC Tanda Kangra ,Himachal pradesh
|
| Type of Sponsor |
Other [self] |
|
|
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 Palvi |
Dr Rajender Prasad government medical college Tanda Kangra Himachal Pradesh |
Operation theatre complex 3rd floor Department of Anesthesia Dr Rajender Prasad government medical college Tanda Kangra
Himachal Pradesh
Kangra
HIMACHAL PRADESH |
9805251059
negipallaavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee Dr Rajender Prasad Government Medical college Tanda Kangra Himachal Pradesh |
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 |
| Intervention |
CNRB vs ESPB |
Group-C -with USG appropriate cervical level will be identified After that, a 3 ml injection of 1 ml 2% lignocaine and 2 ml 16 dexamethasone (8 mg) will be administered under ultrasound guidance.
|
| Comparator Agent |
compare the analgesic efficacy and safety of CNRB vs ESPB |
In Group E - High thoracic Erector spinae plane block(ESPB) Following the identification of the T2 or T3 transverse process, a 23G needle will be advanced injectate of 0.1% ropivacaine 20ml will be given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with upper extremity pain with or without neck pain.
2)Duration of pain more than 6 weeks not responding to conservative
treatment(pharmacological)
3)Patient with cervical radicular pain from C5-T1 level pathology on MRI.
4)18-70 years of either gender
5)BMI between 18-35 |
|
| ExclusionCriteria |
| Details |
1) Patient refusal for consent.
2) Patients with bleeding disorders, deranged coagulation profile.
3) Wound or infection at the needle injection site for the block.
4) Hypersensitivity to any of the local anesthetics and study drugs.
5) Past history of cervical fractures or injury.
6) Patients with history of CVA with or without neurological deficit.
7) Patients with primary or metastatic malignancy.
8) Previous history of lower cervical spine surgery.
9) Congenital gross spinal deformity.
10) Pregnant females |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesic efficacy and safety of cervical nerve root block (CNRB) vs High thoracic ESPB in patients with lower cervical pain |
Intraprocedural assessment -At 0 minute, after 5 minutes of starting the procedure followed by 10 min assessment and then 30 min post procedure assessment for any drug related side effects or any procedural side effects also assessing for pain relief
Post procedural
Assessment via VAS and NDI score for pain relief at 1st week ,2nd week ,6th week, 8th week after the procedure by telephonically contacting the patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the decrease in pain by VAS & NDI before the procedure & after
the procedure at 1-week, 2-week, 6-week, 8 weeks.
2. Any side effects during the procedure from the drugs used in the study.
3. Any intraprocedural complications (inadvertent intravascular, Intraneural, subarachnoid
injection).
4. To access correlation between neck pain & screen time (time spent on computer, mobile
phone).
5. To access improvement in daily work of the patient.
|
Intraprocedural assesment -At 0 minute , after 5 minutes of starting the procedure followed by 10 min assessment & then 30 min post procedure assessment for any drug related side effects or any procedural side effects also assessing for pain relief.
Post procedural -
Assessment via VAS & NDI score for pain relief at 1st week ,2nd week ,6th week, 8th week after the procedure by telephonically contacting the patients. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/06/2025 |
| 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="6"
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
|
It will be a prospective, randomized, controlled study to study the analgesic efficacy and safety for cervical nerve root block (CNRB) vs high thoracic erector spinae block in patients with lower cervical pain. The participants will be allocated in two groups (Group-C and Group-E) by a computer-generated random sequence number method based on their medical history, physical examination, MRI/CT scans. A single anesthesiologist who specializes in interventional pain management and is familiar with US guided pain procedures will determine the level of block to be given and will perform the procedure. Fifty patients in age group 18-70 with BMI between 18-35 with pre- procedural Visual analogue scale (VAS) and neck disability index (NDI) scores evaluated will be included in this study after obtaining informed consent. |