| CTRI Number |
CTRI/2022/04/041748 [Registered on: 08/04/2022] Trial Registered Prospectively |
| Last Modified On: |
01/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Dorsal Penile nerve block with Bupivacaine for the prevention of catheter related bladder discomfort for patients in ICU. |
|
Scientific Title of Study
|
Use of Dorsal Penile nerve block with Bupivacaine for the prevention of catheter related bladder discomfort for patients in ICU. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr OM SHIVA S T |
| Designation |
Post Graduate |
| Affiliation |
Dr. B. R. Ambedkar medical College and hospital |
| Address |
OT COMPLEX, 1ST FLOOR, DEPARTMENT OF ANAESTHESIOLOGY, DR.B.R.AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K.G.HALLI, BENGALURU.
Bangalore
KARNATAKA
560045
India |
| Phone |
7353534654 |
| Fax |
|
| Email |
omshivast@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NAGENDRA PRASAD |
| Designation |
Associate professor |
| Affiliation |
Dr. B. R. Ambedkar medical College and hospital |
| Address |
OT COMPLEX, 1ST FLOOR, DEPARTMENT OF ANAESTHESIOLOGY, DR.B.R.AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K.G.HALLI, BENGALURU.
Bangalore
KARNATAKA
560045
India |
| Phone |
9886428892 |
| Fax |
|
| Email |
nagendraprad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr OM SHIVA S T |
| Designation |
Post Graduate |
| Affiliation |
Dr. B. R. Ambedkar medical College and hospital |
| Address |
OT COMPLEX, 1ST FLOOR, DEPARTMENT OF ANAESTHESIOLOGY, DR.B.R.AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K.G.HALLI, BENGALURU.
Bangalore
KARNATAKA
560045
India |
| Phone |
7353534654 |
| Fax |
|
| Email |
omshivast@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. B. R. Ambedkar medical College and hospital |
|
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Primary Sponsor
|
| Name |
Dr OM SHIVA S T |
| Address |
OT complex, 1st floor, Department of Anaesthesiology, Dr. B. R. Ambedkar medical college and hospital, K.G. Halli. Bengaluru |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr OM SHIVA |
Dr. B. R. Ambedkar medical College and hospital |
ICU, Department of Anaesthesiology, Dr.B.R.Ambedkar medical college and hospital, K.G.Halli, Bengaluru
Bangalore
KARNATAKA |
7353534654
omshivast@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee Dr. B. R. Ambedkar medical College and hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dorsal Penile Nerve block to the patients undergoing urinary catheterization |
Dorsal Penile Nerve block is by Inj. 0.5% Bupivacaine 10ml to the patients undergoing urinary catheterization. Incidence of Catheter Related Bladder Discomfort is monitored for 30mins, 1hour, 2hour, 4hour, 8hour, 12hour and 24hour respectively. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
Patients aged between 18 to 65 years
ASA grade I, II and III status patients |
|
| ExclusionCriteria |
| Details |
Patients refusal to consent
Patients history of bladder outflow obstruction
Know allergies to any anaesthetic agents |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| The incidence and the severity of CRBD, will be assessed according to the following scaling system; No CRBD indicates that there are no complaints of CRBD at all; Mild indicates that complaints of CRBD exists only if the patient was asked about it; Moderate indicates that patient complain of CRBD spontaneously; and Severe indicates that the CRBD causes a spontaneous behavioral response such as flailing limb, strong vocal response, or attempt to pull out catheter. |
To evaluate the incidence of Catheter Related Bladder Discomfort in a patient getting catheterization, monitored at 15mims, 30mins, 1hour,2hour, 4hour,8hour, 12hour and 24hour respectively. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the severity of pain by Numerical analogue scoring |
To evaluate the pain due to Catheter Related Bladder Discomfort in a patient getting catheterization, monitored at 15mims, 30mins, 1hour,2hour, 4hour,8hour, 12hour and 24hour respectively. |
|
|
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)
|
25/04/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
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Brief Summary
|
Catheter related Bladder discomfort (CRBD) due to an indwelling urinary catheter is most common distressing complex of symptoms such as burning sensation, an urge to void, stabbing pain and discomfort in the Supra-pubic region, all thought to be due to friction between the catheter and the urothelium.
There is a wide incidence of CRBD in patients who have urinary catheterization. CRBD commonly causes patient agitation and is accompanied by behavioural responses that may include loud complaining and attempts to remove the urinary catheter. In addition CRBD may result in exacerbated pain and increased urinary tract infections, complications and prolonged hospital stay.
The mechanism of CRBD is mediated by type 3 muscarinic receptor activation, which increases acetylcholine release and then causes the detrusor muscles of the bladder to contract involuntarily. The technique of dorsal penile nerve block has been applied clinically in penile surgeries for decades and satisfactory pain relief effect could be achieved.
The incidence and the severity of CRBD will be assessed according to the following scaling system; No CRBD indicates that there are no complaints of CRBD at all; Mild indicates that complaints of CRBD exists only if the patient was asked about it; Moderate indicates that the patient complain of CRBD spontaneously; and Severe indicates that the CRBD causes a spontaneous behavioural responses such as flailing limb, strong vocal response, or attempt to pull out catheter. Pain will be assessed by Numerical analogue scoring.
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