| CTRI Number |
CTRI/2021/03/032327 [Registered on: 26/03/2021] Trial Registered Prospectively |
| Last Modified On: |
25/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of ropivacaine and levobupivacaine to prevent leg jerk in urinary bladder tumor surgery. |
|
Scientific Title of Study
|
A comparative study of safety and efficacy of ropivacaine 0.75% versus levobupivacaine 0.75% in obturator nerve block for transurethral resection of bladder tumor under spinal. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
komal upadhyay |
| Designation |
PG Resident, 3rd year |
| Affiliation |
Sardar Patel Medical college, BIkaner |
| Address |
Department of Anaesthesia
Sardar Patel Medical College
Bikaner. Rajasthan
Bikaner
RAJASTHAN
334001
India |
| Phone |
9414747576 |
| Fax |
|
| Email |
komal.ccmu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kanta Bhati |
| Designation |
MD Anaesthesiology. Senior Professor and HOD |
| Affiliation |
Sardar Patel Medical college, Bikaner |
| Address |
Department of Anaesthesiology,
Sardar Patel Medical College, Bikaner.
Bikaner
RAJASTHAN
334001
India |
| Phone |
9413466688 |
| Fax |
|
| Email |
drkantabhati67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kanta Bhati |
| Designation |
MD Anaesthesiology. Senior Professor and HOD |
| Affiliation |
Sardar Patel Medical college, Bikaner |
| Address |
Department of Anaesthesiology,
Sardar Patel Medical College, Bikaner.
Bikaner
RAJASTHAN
334001
India |
| Phone |
9413466688 |
| Fax |
|
| Email |
drkantabhati67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar patel medical college , Bikaner , Rajasthan |
|
|
Primary Sponsor
|
| Name |
Sardar Patel Medical College |
| Address |
Sardar patel medical college,Bikaner 334001 |
| 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 |
| komal upadhyay |
Sardar Patel Medical College, Bikaner, Rajasthan |
Sadul ganj, Polytechnic college Road
Bikaner
RAJASTHAN |
9414747576
komal.ccmu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics and Research Board Sardar Patel Medical College Bikaner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N399||Disorder of urinary system, unspecified, (2) ICD-10 Condition: 8||Other Procedures, (3) ICD-10 Condition: N398||Other specified disorders of urinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj. isobaric Ropivacane 0.75% and Inj. Isobaric Levobupivacaine 0.75% |
comparing inj.isobaric ropivacaine 0.75% (7.5mg /ml)(10ml) and inj.isobaric levobupivacaine 0.75% (7.5 mg/ml) (10ml) to prevent jerks during transurethral resection of bladder tumor. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age : 30-70 years
2.ASA : I, II, or III
3.Patient consent.
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Any contra-indication to regional anaesthesia.
3.Patients with advanced cardiac and respiratory insufficiency.
4.History of drug hypersensitivity to local anaesthetic drug.
5.Pre-existing neurologic deficits
6.Skin infections in inguinal or groin region.
7.Prior operations involving the hip and the inguinal region and bleeding tendency
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Comparing the quality of obturator nerve block in between study groups.
2.Access the satisfaction of Surgeon performing TURBT.
|
1 day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the Haemodynamic parameters –
-Systolic blood pressure
-Diastolic blood pressure
-Mean arterial pressure
-Pulse rate
-SPO2
2.To compare the duration of post operative analgesia
3.To observe any side effects and complications related to the drugs.
|
1 day |
|
|
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)
|
27/03/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We are comparing efficacy of two drugs ropivacaine and levobupivacaine for obturator nerve block in TURBT surgeries. |