FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/066372 [Registered on: 26/04/2024] Trial Registered Prospectively
Last Modified On: 25/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing effect of image guided obturator nerve block using nerve stimulation and without nerve stimulation in patients of urinary bladder tumor surgery 
Scientific Title of Study   Comparison of ultrasound guided interfascial obturator nerve block with and without peripheral nerve stimulation in transurethral resection of bladder tumors under spinal anesthesia 
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 Dvij Leuva 
Designation  Resident 
Affiliation  Mahatma Gandhi Medical College And Hospital 
Address  OT Complex 2nd floor Department of Anesthesia Mahatma Gandhi Medical College And Hospital,Sitapura,Jaipur,Rajasthan

Jaipur
RAJASTHAN
302022
India 
Phone  9725902122  
Fax    
Email  dvijleuva86@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sudhir Sachdev 
Designation  Vice chancellor(Mgumst) And Proffesor of Anesthesia 
Affiliation  Mahatma Gandhi Medical College And Hospital 
Address  OT Complex 2nd floor Department of Anesthesia Mahatma Gandhi Medical College And Hospital,Sitapura,Jaipur,Rajasthan

Jaipur
RAJASTHAN
302022
India 
Phone  9829055666  
Fax    
Email  drsudhirmgmch@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sudhir Sachdev 
Designation  Vice chancellor(Mgumst) And Proffesor of Anesthesia 
Affiliation  Mahatma Gandhi Medical College And Hospital 
Address  OT Complex 2nd floor Department of Anesthesia Mahatma Gandhi Medical College And Hospital,Sitapura,Jaipur,Rajasthan

Jaipur
RAJASTHAN
302022
India 
Phone  9829055666  
Fax    
Email  drsudhirmgmch@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi hospital sitapura jaipur rajasthan india 302022 
 
Primary Sponsor  
Name  Mahatma Gandhi Medical College And Hospital 
Address  Department of Anesthesia And Critical Care Mahatma Gandhi Medical College And Hospital sitapura jaipur rajasthan india 302022 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dvij Leuva  Mahatma Gandhi Hospital  OT complex 2nd Floor Department of Anesthesia Mahatma Gandhi Hospital,Sitapura,Jaipur
Jaipur
RAJASTHAN 		 9725902122

dvijleuva86@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC,MGMCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C672||Malignant neoplasm of lateral wallof bladder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Patient will receive USG guided Obturator nerve block using 0.5% bupivicaine 10ml with and without Peripheral nerve stimulation  52 consenting patients fulfilling inclusion criteria undergoing transurethral resection of bladder tumors under SAB plus USG guided Obturator nerve block with and without peripheral nerve stimulator during the study period(March 2023 to August 2024) will be randomly allocated in two groups of 26 each using chit in box methods as follows: Group 1 will receieve USG guided Obturator nerve block using 0.5% bupivicaine 10 ml with peripheral nerve stimulator. Group 2 will receive USG guided Obturator nerve block using 0.5% bupivicaine 10ml without peripheral nerve stimulation. Route of administration: Local infiltartion around the nerve. 
Intervention  Patient will receive USG guided obturator nerve block using 0.5% bupivicaine 10ml with peripheral nerve stimulation.   Obturator nerve block with and without peripheral nerve stimulator during the study period(March 2023 to August 2024) will be randomly allocated in two groups of 26 each using chit in box methods as follows: Group 1 will receieve USG guided Obturator nerve block using 0.5% bupivicaine 10 ml with peripheral nerve stimulator. Group 2 will receive USG guided Obturator nerve block using 0.5% bupivicaine 10ml without peripheral nerve stimulation. Route of administration: Local infiltartion around the nerve. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients scheduled for TURBT surgery under spinal anesthesia.
ASA grade 1,2,3 
 
ExclusionCriteria 
Details  1)Peripheral neuropathy and neuropsychiatric diorders.
2)motor or sensory deficit in lower extremities.
3)coagulopathy
4)Patients on anticoagulant medication 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of adjuvant peripheral nerve stimulator on the effect of block.  The effect of Obturator nerve block will be monitored during intraoperative period at 10 min,30 min,1 hour 
 
Secondary Outcome  
Outcome  TimePoints 
Pulse rate,Blood pressure,Spo2,Temprature,Respiratory rate.  The effects will be assessed during intraoperative period at 10min, 30min & 1hour 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   10/05/2024 
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="1"
Months="5"
Days="30" 
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   Transurethral resection of bladder tumor is a commonly done theraputic procedure for bladder tumors.Spinal anesthesia provide many advantages over general anesthesia such as reduced risk of bleeding,early recognisation of bladder perforation and avoiding complications assosiated with general anesthesia in geriatric popuation.The only short coming with spinal anesthesia is sparing of obturator nerve which can trigger inadverent adductor muscle spasm and thus may cause bladder laceration,perforation etc.Spinal anesthesia with a selective obturator nerve block is an alternative to general anesthesia for TURBT.Beacause obturator nerve is very thin and embedded in an  intermuscular septum,it is difficult to be electriclly stimulated.moreover it is difficult to be visualized even in ultrasound images,so interfascial plane block is administered.thus this study will evaluate whether simultaneous use of peripheral nerve stimulation along with ultrasound guidance can offer any advantage over sole use of ultrasound. 
Close