| CTRI Number |
CTRI/2025/11/097434 [Registered on: 14/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two anesthesia techniques, paravertebral block and spinal anesthesia, to find which gives better pain control after inguinal hernia surgery |
|
Scientific Title of Study
|
Comparative study of paravertebral block versus spinal anesthesia for inguinal hernia repair |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Arun Kumar B |
| Designation |
Professor |
| Affiliation |
Vinayaka missions Kirupanandha Variyar Medical College And Hospitals Chinnaseeragapadi Salem 636308 |
| Address |
Room No 15
Department of Anesthesia
Vinayaka missions Kirupanandha Variyar Medical College
Salem 636308
Salem
TAMIL NADU
636308
India |
| Phone |
9840623673 |
| Fax |
|
| Email |
cruise2010.mmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Arun Kumar B |
| Designation |
Professor |
| Affiliation |
Vinayaka missions Kirupanandha Variyar Medical College Chinnaseeragapadi Salem 636308 |
| Address |
Room No 15
Department of Anesthesia Vinayaka missions Kirupanandha Variyar Medical College
Salem 636308
Salem
TAMIL NADU
636308
India |
| Phone |
9840623673 |
| Fax |
|
| Email |
cruise2010.mmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shri Harini K |
| Designation |
Postgraduate |
| Affiliation |
Vinayaka missions Kirupanandha Variyar Medical College Chinnaseeragapadi Salem 636308 |
| Address |
Room No 15
Department of Anesthesia
Vinayaka missions Kirupanandha Variyar Medical College
Salem 636308
Salem
TAMIL NADU
636308
India |
| Phone |
9629574742 |
| Fax |
|
| Email |
harini.kans@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupanandha Variyar Medical College And Hospital
India
Tamil Nadu
Salem 636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka missions Kirupanandha Variyar Medical College and Hospitals Salem |
| Address |
Room No 15
Department of Anesthesia
Vinayaka missions kirupanandha variyar Medical college
Salem 636308
Tamil Nadu
India |
| Type of Sponsor |
Private 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 Shri Harini K |
Vinayaka missions Kirupanandha Variyar Medical College And Hospitals Salem |
Room No 15
Department of Aneathesia
Vinayaka Missions Kirupanandha Variyar Medical College And Hospitals
Salem 636308
Tamil nadu
India
Salem
TAMIL NADU |
9629574742
harini.kans@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UNIVERSITY ETHICS COMMITEE VMRF-DU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparative Study Of Paravertebral Block Versus Spinal Anesthesia For Inguinal Hernia Repair |
To Study Paravertebral Block as Sole Anesthetic Technique For Inguinal Hernia Repair in a study period of 6 months |
| Comparator Agent |
Comparative Study Of Paravertebral Block Versus Spinal Anesthesia For Inguinal Hernia Repair |
To Compare the Level of sensory and motor blockade occuring in Paravertebral block and Spinal anesthesia in a study period of 6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient giving valid informed consent
2.ASA grade 1 and 2
3.Age between 20 TO 60 years
4.Elective inguinal hernia repair |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.ASA grade 3 and 4
3.Age less than 20 years and more than 60 years
4.Pregnancy
5.Morbid obesity
6.Full Stomach
7.Coagulation Disorders
8.CAD
9.Renal and hepatic dysfunction
10.Allergy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study Paravertebral block as sole anesthetic technique for inguinal hernia repair |
15 minute sfor Pin prick sensation and 30 minutes for Motor blockade |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the level of motor & sensory blockade occuring in Paravertebral block & Spinal anesthesia |
For paravertebral block 15 minutes fir pin prick sensation & 30 minutes for motor blockade |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/11/2025 |
| 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="0"
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
|
THIS IS A PROSPECTIVE RANDOMISED DOUBLE BLINDED STUDY TO COMPARE PARAVERTEBRAL BLOCK VERSUS SPINAL ANESTHESIA FOR INGUINAL HERNIA REPAIR. THE PRIMARY OBJECTIVE OF THE STUDY IS TO STUDY PARAVERTEBRAL BLOCK AS A SOLE ANESTHETIC TECHNIQUE AND THE SECONDARY OBJECTIVE IS TO COMPARE THE LEVEL OF MOTOR AND SENSORY BLOCKADE OCCURING IN PARAVERTEBRAL BLOCK AND SPINAL ANESTHESIA . THE STUDY INCLUDES A SAMPLE SIZE OF 60 PATIENTS DIVIDED AS 30 PATIENTS UNDERGOING HENIA REPAIR UNDER SPINAL ANESTHESIA AND 30 PATIENTS UNDERGOING HERNIA UNDER PARAVERTEBRAL BLOCK.THIS STUDY WILL HELP IN CONCLUDING THE BEST MODE OF ANESTHESIA APPROCH FOR INGUINAL HERNIA REPAIR. |