| CTRI Number |
CTRI/2024/10/074906 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Using Sub Arachanoid Block with Bupivacaine Heavy 0.25 percent for urological procedures. |
|
Scientific Title of Study
|
Hyperbaric spinal Anaesthesia with Bupivacaine 0.25 percent for urological procedures. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NEHA KUMAR |
| Designation |
Assistant Professor |
| Affiliation |
GSVM MEDICAL COLLEGE, KANPUR |
| Address |
Department Of Anaesthesia
GSVM Medical College and Hallet
Kanpur
Kanpur Nagar
UTTAR PRADESH
208005
India |
| Phone |
08874311115 |
| Fax |
|
| Email |
dr.nehamishra86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NEHA KUMAR |
| Designation |
Assistant Professor |
| Affiliation |
GSVM MEDICAL COLLEGE, KANPUR |
| Address |
Department of anaesthesia
GSVM Medical college and Hallet
kanpur
Department of anaesthesia
GSVM Medical college and Hallet
kanpur
Kanpur Nagar
UTTAR PRADESH
208005
India |
| Phone |
08874311115 |
| Fax |
|
| Email |
dr.nehamishra86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NEHA KUMAR |
| Designation |
Assistant Professor |
| Affiliation |
GSVM MEDICAL COLLEGE, KANPUR |
| Address |
Department of anaesthesia
GSVM Medical college and Hallet
kanpur
Department of anaesthesia
GSVM Medical college and Hallet
kanpur
Kanpur Nagar
UTTAR PRADESH
208005
India |
| Phone |
08874311115 |
| Fax |
|
| Email |
dr.nehamishra86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia.
GSVM Medical College
Kanpur 208005
Uttar Pradesh
INDIA |
|
|
Primary Sponsor
|
| Name |
GSVM |
| Address |
GSVM Medical college and hallet
kanpur
uttar pradesh |
| 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 NEHA MISHRA |
GSVM MEDICAL COLLEGE, KANPUR |
Department of Anaesthesia, critical care and pain
Anaesthesia division
Kanpur Nagar
UTTAR PRADESH |
08874311115
dr.nehamishra86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSVM MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N289||Disorder of kidney and ureter, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HYPERBARIC BUPIVACAINE 0.25 % |
Hyperbaric spinal Anaesthesia with Bupivacaine 0.25 % for urological procedures
Dose: 1ml
Frequency: single shot
Route of Administration: Intra thecal
Duration: 4 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with American society of anaestheslogist (ASA) score: I and II
2) Elective urological endoscopic surgery.
3) Duration of surgery not exceeding 45 min
|
|
| ExclusionCriteria |
| Details |
1) Negative consent
2) Patients with ASA score III, IV
3) Body mass index (BMI) > 30 kg/m2
4) History of obstructive sleep apnoea
5) Anticipated difficult intubation
6) Spine deformities, previous spine surgery
7) Coagulation abnormalities
8) Allergy to local anaesthetics
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effective sensory block ( onset and duration)
Effective motor block ( onset and duration)
Hemodynamic stability
|
Base line, 4 weeks, 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effects |
Base line, 4 weeks, 8 weeks. |
|
|
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)
|
20/10/2024 |
| 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="4"
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 use bupivacaine 0.25 % in lower urological procedures. a) Primary aim: Effective sensory block ( onset and duration) Effective motor block ( onset and duration) Hemodynamic stability b) Secondary aim: Adverse effects if any |