| CTRI Number |
CTRI/2022/08/044958 [Registered on: 26/08/2022] Trial Registered Prospectively |
| Last Modified On: |
25/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
It is a study to see the effect of erector spinae plane block in post herpetic neuralgia patients.
|
|
Scientific Title of Study
|
A study to Evaluate Efficacy of Erector Spinae Plane Block for Postherpetic Neuralgia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shashi Kiran |
| Designation |
Professor |
| Affiliation |
Pgims rohtak |
| Address |
Department of Anaesthesiology and Critical Care,
Pt.B.D.Sharma PGIMS,Rohtak Rohtak
HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9416763899 |
| Fax |
|
| Email |
drshashi64@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Sunaria |
| Designation |
Post graduate student |
| Affiliation |
Pgims rohtak |
| Address |
Department of Anaesthesiology and Critical Care,
Pt.B.D.Sharma PGIMS,Rohtak Rohtak
HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9992689503 |
| Fax |
|
| Email |
drshivanisunariya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Sunaria |
| Designation |
Post graduate student |
| Affiliation |
Pgims rohtak |
| Address |
Department of Anaesthesiology and Critical Care,
Pt.B.D.Sharma PGIMS,Rohtak Rohtak
HARYANA
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9992689503 |
| Fax |
|
| Email |
drshivanisunariya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical Care, Pt. B. D .Sharma PGIMS, Rohtak, Haryana |
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, Pt. B. D .Sharma PGIMS, Rohtak, Haryana |
| 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 Shivani Sunaria |
Pt BDS PGIMS Rohtak |
Department of anesthesiology and critical care, Pt BDS PGIMS Rohtak Haryana - 124001
Rohtak
HARYANA |
9992689503
drshivanisunariya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee, Pt BD Sharma Institute of research Committee Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B028||Zoster with other complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
USG guided Erector spinae plane block for postherpetic neuralgia |
Post herpetic neuralgia is chronic neuropathic pain that occurs at the site of herpes zoster rash persisting after healing of cutaneous lesions. USG guided Erector spinae plane block is interfascial plane block that targets dorsal and ventral rami of spinal nerves. The total duration of this intervention is around 1/2 an hour. |
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Thirty patients of either sex above thirty years of age having persistent pain after acute phase of unilateral thoracic herpes zoster not responding to four weeks of analgesics and conservative therapy |
|
| ExclusionCriteria |
| Details |
Patients with known contraindications for block interventions eg infection at site of block, coagulopathy, history of adverse reaction to fentanyl and ropivacaine, uncontrolled diabetes mellitus, patients not consenting for ESPB |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain assessment before procedure using Visual analog Scale and thirty minutes, one week and four weeks after procedure using Numerical Rating Scale. |
a)Before procedure.
b)Thirty minutes after procedure.
c)One week after procedure.
d)Four weeks after procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, open labelled study to be conducted in Department of anesthesiology, Pt BD Sharma PGIMS Rohtak. Thirty patients of either sex with age above 30 yrs with post herpetic neuralgia of thoracic region will be included in the study when there is no response to 4-week analgesic and conservative treatment. After explaining about the intervention and taking informed written consent patients will be given USG guided erector spinae plane block. Pain assessment will be done before the procedure and after the procedure (30 min, 1 week, 4 week). |