| CTRI Number |
CTRI/2024/04/065913 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study effect of obturator nerve block in bladder tumor resection under spinal anaesthesia. |
|
Scientific Title of Study
|
To determine the effect of nerve stimulator guided Obturator nerve block in transurethral resection of bladder tumor under spinal anaesthesia.Randomized Clinical trial. |
| 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 Basant Kumar Dindor |
| Designation |
Associate Professor |
| Affiliation |
Department of Anaesthesiology Rabindra nath medical collage udaipur |
| Address |
Department of Anaesthesia Rabindra Nath Tagore Medical College and MB government hospital
Udaipur Court Chowk Citys Prime Health Care Area
Udaipur
RAJASTHAN
313001
India |
| Phone |
9602237852 |
| Fax |
|
| Email |
basant_17@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basant Kumar Dindor |
| Designation |
Associate Professor |
| Affiliation |
Department of Anaesthesiology Rabindra nath medical collage udaipur |
| Address |
Department of anaesthesiology
Rabindra Nath Tagore Medical College and MB Hospital Udaipur Court Chowk Citys Prime Health Care Area
Udaipur
RAJASTHAN
313001
India |
| Phone |
9602237852 |
| Fax |
|
| Email |
basant_17@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kuldeep Singh Devda |
| Designation |
Postgraduate student |
| Affiliation |
Department of Anaesthesiology Rabindra nathtagore medical collage udaipur |
| Address |
Department of anaesthesia Ravindra Nath Tagore Medical College and MB government hospital, Udaipur Court Chowk Citys Prime Health Care Area
Udaipur
RAJASTHAN
313001
India |
| Phone |
09672328960 |
| Fax |
|
| Email |
kuldeep12693@gmail.com |
|
|
Source of Monetary or Material Support
|
| RNT medical collage udaipur |
|
|
Primary Sponsor
|
| Name |
RNT medical collage udaipur |
| Address |
Department of anaesthesiology rabindra nath tagore medical collage udaipue rajasthan |
| 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 basant kumar dindor |
Urology operation theater |
Ravindra Nath Tagore Medical College, Udaipur
Udaipur
RAJASTHAN |
09672328960
basant_17@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RNT MEDICAL COLLEGE CONTROLLER ATTACHED HOSPITAL 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: C672||Malignant neoplasm of lateral wallof bladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
unilateral obturator nerve block with nerve stimulator |
both groups will receive spinal anaesthesia with inj bupivacain 12.5 mg
in control group no intervention will done and in study group Obturator nerve block will be given with 10 ml of ropivacain 0.5% using nerve stimulator |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having inferolateral and bladder neck tumors that were scheduled for transurethral resection of bladder tumor. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Pregnant patients.
3. Patients with ASA physical status Grade III and IV
4.Patients with a known allergy to local anaesthetics and patients with
previous surgery or scars in the ONB region, coagulopathy and
neuromuscular disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The ability to resect the tumor without any adductor reflex |
The ability to resect the tumor without any adductor reflex |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic changes
surgeon satisfaction score |
nil |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
01/05/2024 |
| 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="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
|
in this prospective randomized controlled study we plan to investigate the effect of nerve stimulator guided obturator nervr block on adductor spasm in the patients who underwent TURBT for bladder tumour under spinal anaesthesia |