| CTRI Number |
CTRI/2026/01/101352 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
10/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO see THE efficiency OF PARAVERTEBRAL BLOCK AND INTERCOSTAL NERVE BLOCK FOR HERPES ZOSTER |
|
Scientific Title of Study
|
TO ASSESS THE EFFICACY OF PARAVERTEBRAL BLOCK AND INTERCOSTAL NERVE BLOCK FOR THORACIC HERPES ZOSTER : RANDOMIZED COMPARATIVE 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 |
Nidhi Chincholi |
| Designation |
postgraduate |
| Affiliation |
JSS MEDICAL COLLEGE , mysore |
| Address |
jss hospital ,Mahatma Gandhi Road, Fort Mohalla, Mysore, Karnataka 570004
19th cross ramanuja road, mysore
Mysore
KARNATAKA
570004
India |
| Phone |
9108930742 |
| Fax |
|
| Email |
nidhichincholi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pratibha R Matche |
| Designation |
associate professor |
| Affiliation |
JSS MEDICAL COLLEGE , Mysore |
| Address |
jss hospital ,Mahatma Gandhi Road, Fort Mohalla, Mysore Karnataka 570004
Ramanuja road , 19th cross , mysuru
Mysore
KARNATAKA
570004
India |
| Phone |
9108930742 |
| Fax |
|
| Email |
prathibarmatche@jssuni.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nidhi Chincholi |
| Designation |
postgraduate |
| Affiliation |
JSS MEDICAL COLLEGE , MYSORE |
| Address |
jss hospital ,Mahatma Gandhi Road, Fort Mohalla, Mysore, Karnataka 570004
Ramanuja road , 19th cross mysore
Mysore
KARNATAKA
570004
India |
| Phone |
9108930742 |
| Fax |
|
| Email |
nidhichincholi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIDHI CHINCHOLI |
| Address |
JSS HOSPITAL , Mahatma Gandhi Road, Fort Mohalla, Mysuru, Karnataka 570004 |
| 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 |
| NIDHI CHINCHOLI |
JSS HOSPITAL , MYSURU |
JSS HOSPITAL , Mahatma Gandhi Road, Fort Mohalla, Mysuru, Karnataka 570004
Mysore
KARNATAKA |
9108930742
nidhichincholi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS MEDICAL COLLEEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B029||Zoster without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intercostal block |
2.5 mL bupivacaine HCl 0.25% + 2 mg dexamethasone is injected for each level |
| Intervention |
paravertebral block |
15 ml of 0.25% Bupivacaine with 8 mg of Dexamethasone |
| Comparator Agent |
standard antiviral therapy |
standard treatment for HZ in the form of oral antiviral therapy with Tab Valacyclovir 1gm, 3 times daily for 7 days , topical antibiotics ointment Fucidin BD for 1 week and concomitant neuropathic treatment with Tab Pregabalin 75mg ( HS) a day . |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Age greater 40 years of age of either gender
Herpes zoster greater 1 week since onset of rash
HZ involving up to 2 thoracic dermatomes
Numerical rating score (NRS)greater 4
Pain refractory to conservative management
|
|
| ExclusionCriteria |
| Details |
Infection at site of injection
Patients with coagulopathy or on anticoagulants
Patients on chemotherapy or immunosuppressive drugs
Any contraindication to neuraxial injection
Uncontrolled medical illness
Hypersensitivity to LA
Pregnancy and lactating women
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| decrease in NRS score post block for herpes zoster |
decrease in pain NRS score post block for thoracic herpes zoster |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| decrease in incidence of PHN |
6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
21/01/2026 |
| 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)
|
Closed to Recruitment of Participants |
| 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
|
Study design & technique : Randomized Comparative Prospective study Study duration : 18 monthsStudy design & technique : Randomized Comparative Prospective study 40 patients aged greater than 40 years of age of either gender with herpes zoster greater than 1 week since onset of rash, involving up to 2 thoracic dermatomes with Numerical rating score (NRS) greater than 4 who shall visit the pain clinic and fulfill the inclusion and exclusion criteria will be included . After taking their due consent ,patients will be randomized into 2 groups with 20 in each group using sealed opaque envelope techniquey duration : 18 months Both the blocks will be performed under ultrasound guidance using a high frequency linear probe following strict aseptic precautions and using standard American Society of Anesthesiology monitoring Group I – INTERCOSTAL NERVE BLOCK 2.5 mL bupivacaine 0.25% + 2 mg dexamethasone is injected for each level . Group P :PARAVERTEBRAL BLOCK 15 ml of 0.25% Bupivacaine with 8 mg of Dexamethasone will be injected for into the thoracic paravertebral space . Follow up: Pre procedure, immediate post procedure and at intervals of 2, 4, 12 and 24 weeks NRS,S - LANSS , SF 36 , complictions (if any ) and the incidence of Post herpetic neuralgia will be assessed
|