| CTRI Number |
CTRI/2025/03/082743 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of 2 drugs in patients undergoing urology surgeries |
|
Scientific Title of Study
|
Evaluation of hyperbaric levobupivacaine and hyperbaric bupivacaine in patients undergoing transurethral endoscopic surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dilasha Verma |
| Designation |
PG Resident |
| Affiliation |
gandhi medical college bhopal |
| Address |
Department of Anaesthesiology,hamidia hospital , Bhopal
Department of Anaesthesiology,hamidia hospital , Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9826764553 |
| Fax |
|
| Email |
dilashaverma12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajkumar Ahirwal |
| Designation |
Associate Professor |
| Affiliation |
gandhi medical college bhopal |
| Address |
Department of anaesthesia gandhi medical college bhopal
Department of anaesthesia gandhi medical college bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9826742427 |
| Fax |
|
| Email |
drrajkumarahirwal@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajkumar Ahirwal |
| Designation |
Associate Professor |
| Affiliation |
gandhi medical college bhopal |
| Address |
Department of anaesthesia gandhi medical college bhopal
Department of anaesthesia gandhi medical college bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9826742427 |
| Fax |
|
| Email |
drrajkumarahirwal@ymail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia Gandhi medical college , Hamidia hospital bhopal , pincode - 462001
|
|
|
Primary Sponsor
|
| Name |
Gandhi Medical College |
| Address |
Gandhi Medical College, Bhopal , MP , 462001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Rajkumar Ahirwal |
Department of anaesthesia gandhi medical college bhopal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| dilasha verma |
Gandhi medical college |
Department of anaesthesia gandhi medical college bhopal
Bhopal
MADHYA PRADESH |
9826764553
dilashaverma12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N359||Urethral stricture, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine and Levobupivacaine in surgeries |
Evaluation of Hyperbaric Bupivacaine and Hyperbaric Levobupivacaine in patients undergoing transurethral endoscopic surgeries |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I&II
All patients undergoing transurethral endoscopic surgeries
|
|
| ExclusionCriteria |
| Details |
patient with neurological disease
spine/neurological deformities
local skin infection/disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
TO evaluate the effect of hyperbaric bupivacaine on the onset and duration of sensory and motor block
to evaluate perioperative hemodynamic effects |
TO evaluate the effect of hyperbaric bupivacaine on the onset and duration of sensory and motor block (baseline to
after 180 mins of block)
to evaluate perioperative hemodynamic effects |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to evaluate postoperative analgesia
to evaluate the occurrence of side effects & complications if any |
Baseline to after 180 mins of block |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
20/04/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
To evaluate the effect of hyperbaric levobupivacaine and hyperbaric bupivacaine on onset and duration of sensory and motor block To evaluate Perioperative hemodynamic effects to evaluate postoperative analgesia |