| CTRI Number |
CTRI/2016/05/006910 [Registered on: 09/05/2016] Trial Registered Retrospectively |
| Last Modified On: |
09/05/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study the efficacy of Ultrasound Guided Obturator Nerve Block in Prostrate Surgeries |
|
Scientific Title of Study
|
A Comparative Study of Efficacy of Ultrasound guided Obturator Nerve Block versus neuro-stimulation assisted Ultrasound guided Obturator Nerve Block in the patients with infero-lateral bladder wall tumors for TURBT surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roopam Chhabra |
| Designation |
Consultant Anaesthesiology |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Apollo Spectra Hospital, New Rohtak Road, Sector-14, Karol Bagh
Central
DELHI
110005
India |
| Phone |
9891977122 |
| Fax |
|
| Email |
drroopam2010@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Roopam Chhabra |
| Designation |
Consultant Anaesthesiology |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Apollo Spectra Hospital, New Rohtak Road, Sector-14, Karol Bagh
Central
DELHI
110005
India |
| Phone |
9891977122 |
| Fax |
|
| Email |
drroopam2010@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Roopam Chhabra |
| Designation |
Consultant Anaesthesiology |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Apollo Spectra Hospital, New Rohtak Road, Sector-14, Karol Bagh
Central
DELHI
110005
India |
| Phone |
9891977122 |
| Fax |
|
| Email |
drroopam2010@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Cancer Institute and Research Centre, Rohini, Delhi |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Sector-5, Rohini, Delhi-110085 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Roopam Chhabra |
Rajiv Gandhi Cancer Institute & Research Centre |
Sector-5, Rohini, Delhi
North West
DELHI |
9891977122
drroopam2010@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB RGCIRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Bladder Tumor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Peripheral Nerve Stimulator along with Ultrasound to block the Obturator N. |
Peripheral Nerve Stimulator (PNS) is used in conjunction with Ultrasound to locate and block the Obturator N.during TRUBT surgery to prevent Obturator Reflex |
| Intervention |
Ultrasound guided Obturator N. block |
Ultrasound is used to locate the Obturator N. and block it using anesthetic agent during TURBT surgeries to prevent Obturator reflex |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
infero-lateral bladder wall tumor scheduled for TURBT operation |
|
| ExclusionCriteria |
| Details |
• Patient refusal to give consent
• Pre-existing adductor muscle weakness
• Coagulopathy
• Infection at local site
• Allergy to local anaesthetics
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Obturator N. block onset time |
Obturator N. block onset time in minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Obturator N. block efficacy,total anaesthesia related time, motor block success at 15 minutes interval complications if any |
upto 60 minutes post block |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/08/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Obturator nerve Block (ONB) is an effective stratergy to prevent obturator reflex during the trans urethral bladder tumor (TURBT) surgery. The present study evaluates the comparative efficacy of ultra sound guided ONB versus neuro-stimulation assisted ultra sound guided ONB in TURBT surgeries done under spinal anaesthesia. A total of 100 patients were assessed by an independent observer masked to group allocation. The result showed that neuro-stimulation assisted ultra sound guided ONB is a better alternative than ultra sound guided ONB in terms of ONB efficacy and less failure |