| CTRI Number |
CTRI/2018/03/012475 [Registered on: 12/03/2018] Trial Registered Prospectively |
| Last Modified On: |
02/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the efficacy of stellate ganglion block with local anaesthetic only versus local anaesthetic with steroid in management of patients having upper extremity chronic regional pain syndrome. |
|
Scientific Title of Study
|
A comparative study of effectiveness of stellate ganglion block with local anaesthetic only versus local anaesthetic with steroid in management of chronic regional pain syndrome of upper extremity. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rama Chackraborty |
| Designation |
Fellow, ESI Institute of Pain Management |
| Affiliation |
ESI Institute of Pain Management |
| Address |
161/A Baruipara Lane, Post Office: Alambazar, P.S- Baranagar, Kolkata
301/3 APC Road, Kolkata 700009.
Kolkata
WEST BENGAL
700035
India |
| Phone |
9433865165 |
| Fax |
|
| Email |
ramaghatak1976@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subrata Goswami |
| Designation |
Course Director |
| Affiliation |
ESI Institute of Pain Management |
| Address |
Pain Management Department, ESI Institute of Pain Management, ESI Hospital, Sealdah.
301/3 APC Road, Kolkata 700009.
Kolkata
WEST BENGAL
700009
India |
| Phone |
9830430430 |
| Fax |
|
| Email |
drsgoswami@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subrata Goswami |
| Designation |
Course Director |
| Affiliation |
ESI Institute of Pain Management |
| Address |
Pain Management Department, ESI institute of Pain Management, ESI Hospital, Sealdah
301/3 APC Road, Kolkata 700009.
Kolkata
WEST BENGAL
700009
India |
| Phone |
9830430430 |
| Fax |
|
| Email |
drsgoswami@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ESI Institute of Pain Management ESI Hospital Sealdah |
| Address |
301/3 APC Road, Kolkata 700009 |
| 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 Rama Chackraborty |
ESI Hospital, Sealdah |
Pain Management Department, ESI Institute of Pain Management, ESI Hospital Sealdah, 301/3 APC Road, Kolkata 700009.
Kolkata
WEST BENGAL |
9433865165
ramaghatak1976@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ESI Institute of Pain Management. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G905||Complex regional pain syndrome I (CRPS I), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Local Anaesthetic |
Stellate ganglion block with lignocaine only |
| Comparator Agent |
Local anaesthetic with steroid |
Stellate ganglion block with lignocaine and depot preparation of methyl prednisolone |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having pain for more than 3 months despite conservative therapy (e.g. exercise, physical modalities & medication.
2. Patient taking antineuropathic medicine more than 4 weeks
3. Degree of pain more than 5 according to numeric rating scale |
|
| ExclusionCriteria |
| Details |
1. Pregnancy & lactating mother
2. Cardio-vascular pathology
3. Metastatic condition
4. Allergy to medication used in procedure
5. blood coagulation disorder |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain score in Numeric Rating Scale |
Before procedure and 1, 4 and 6 weeks after procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
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 4 |
|
Date of First Enrollment (India)
|
19/03/2018 |
| 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
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
After getting consent, 30 patients of upper extremity Chronic Regional Pain Syndrome attending to a OPD of Pain Management Department of an urban Hospital will be randomly allocated into two groups. Group A will receive Stellate ganglion block with local anaesthetic only.The other group Group B will receive Stellate ganglion block with local anaesthetic and steroid. The pain score in Numeric Rating Scale (NRS) will be measured before intervention and 1, 4 & 6 weeks after the intervention from each patient and the pain reduction will be compared between two groups using appropriate statistical test. |