| CTRI Number |
CTRI/2023/09/057724 [Registered on: 15/09/2023] Trial Registered Prospectively |
| Last Modified On: |
28/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of 2 drugs (ropivacaine and bupivacaine) in spinal anaesthesia for hernia surgeries. |
|
Scientific Title of Study
|
Comparison of intrathecal hyperbaric Ropivacaine 0.75% with hyperbaric Bupivacaine 0.5% for inguinal hernia repair: A randomized double-blind 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 |
Dr Indira Kumari |
| Designation |
Senior Professor |
| Affiliation |
Rabindranath Tagore Medical College, Udaipur |
| Address |
Dept of Anaesthesiology
Rabindranath Tagore Medical College, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414176760 |
| Fax |
|
| Email |
dr_ikumari@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indira Kumari |
| Designation |
Senior Professor |
| Affiliation |
Rabindranath Tagore Medical College, Udaipur |
| Address |
Dept of Anaesthesiology
Rabindranath Tagore Medical College, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414176760 |
| Fax |
|
| Email |
dr_ikumari@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Astha Negi |
| Designation |
PG Resident |
| Affiliation |
Rabindranath Tagore Medical College, Udaipur |
| Address |
Dept of Anaesthesiology
Rabindranath Tagore Medical College, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
8279799895 |
| Fax |
|
| Email |
asthanegi18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesiology
Rabindranath Tagore Medical College Udaipur |
|
|
Primary Sponsor
|
| Name |
MB government hospital |
| Address |
Department of anaesthesiology Rabindranath Tagore Medical College Udaipur |
| 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 Indira Kumari |
Maharana Bhupal Government hospital |
Main Operation Theatre(surgery),2nd floor
RNT Medical College
Udaipur
RAJASTHAN |
9414176760
dr_ikumari@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RNT MEDICAL COLLEGE CONTROLLER AND ATTACHED HOSPITALS UDAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
comparison between intrathecal hyperbaric Ropivacaine and hyperbaric Bupivacaine |
Intrathecal hyperbaric Ropivacaine (0.75%) 2.5ml Intrathecal hyperbaric Bupivacaine (0.5%) 2.5ml |
| Comparator Agent |
Intrathecal hyperbaric Bupivacaine |
Hyperbaric Bupivacaine 0.5%(2.5ml) |
| Comparator Agent |
Intrathecal hyperbaric Ropivacaine |
Hyperbaric Ropivacaine 0.75%(2.5ml) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
ASA grade I & II
Undergoing elective unilateral inguinal hernia surgeries under sunarachnoid block |
|
| ExclusionCriteria |
| Details |
Patient not willing to participate in the study
Patient with contraindication to spinal anaesthesia
Patient allergic to any drug
Failure of spinal anaesthesia cases in which general anaesthesia will be required
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of sensory block |
Upto 3 Hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Onset of sensory & motor block
duration of motor block
haemodynamic parameter
complications if any |
Upto 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
21/09/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
My clinical study is comparison of intrathecal hyperbaric Ropivacaine 0.75% with hyperbaric Bupivacaine 0.5% for inguinal hernia repair, kindly consider it for CTRI Registration |