| CTRI Number |
CTRI/2024/02/063050 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
16/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate the occurrence of discomfort and pain related to the urinary catheter in patients undergoing cancer surgery |
|
Scientific Title of Study
|
Catheter Related Bladder Discomfort (CRBD) in oncological surgeries – incidence and impact of multimodal analgesia – a single center, prospective, observational study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 4327_Protocol 1.1 dated 27.12.23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumitra Bakshi |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Centre,
Tata Memorial Centre
Dr Ernest Borges Road
Parel East
Mumbai
Maharashtra
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869334449 |
| Fax |
|
| Email |
sumitrabakshi@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumitra Bakshi |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Centre,
Tata Memorial Centre
Dr Ernest Borges Road
Parel East
Mumbai
Maharashtra
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869334449 |
| Fax |
|
| Email |
sumitrabakshi@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mugdha Satao |
| Designation |
Junior Resident |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Centre,
Tata Memorial Centre
Dr Ernest Borges Road
Parel East
Mumbai
Maharashtra
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8275918803 |
| Fax |
|
| Email |
mugs287@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre, Mumbai |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dept of Anaesthesia, Critical Care and Pain,
Tata Memorial Centre,
Dr Ernest Borges Road,
Parel East,
Mumbai
Maharashtra
400012
India |
| 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 Sumitra Bakshi |
Tata Memorial Hospital |
Tata Memorial Centre
Dr Ernest Borges Road
Parel East
Mumbai
400012
Mumbai
MAHARASHTRA |
9869334449
sumitrabakshi@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
NA |
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients more than or equal to 18 years of age.
2.Patients undergoing oncological surgeries under general anesthesia and needing urinary catheterization.
|
|
| ExclusionCriteria |
| Details |
1.Patients unwilling to participate in the study.
2.Patients catheterized prior to surgery.
3.Multiple attempts at catheterization.
4.Urogenital and pelvic surgeries.
5.Surgeries with cognitive impairment in the post-operative period (neurosurgeries)
6.Patients shifted for elective ventilation (for more than 12 hrs.) in the immediate post-operative period.
7.Since very few patients undergo surgery under spinal +/- epidural anesthesia, these patients will be excluded to avoid too many confounding factors.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Observation of incidence of CRBD in the post operative period in oncological surgeries where multimodal analgesia is used. |
In the post-operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the severity of CRBD in the immediate post-operative period (first 24 hrs.)
2.To understand correlation between Morphine Equivalent (ME) for surgical pain and incidence of CRBD in the peri-operative period.
3.Disparity in incidence of CRBD when using the CRBD scale and NRS scale
4.To understand the treatment offered to patients complaining of CRBD and its effect on reduction of the severity of CRBD.
|
In the post-operative period |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
29/02/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Catheter related bladder discomfort (CRBD) is a significant but neglected event in the post anesthesia care unit (PACU). It is defined as the urgency to pass urine or pain/discomfort in the suprapubic region. Indwelling urinary catheters are used in various clinical situations however these urinary catheters can be quite distressing and can trigger serious behavioral reactions such as confusion and agitation and can also lead to traumatic attempts at removal of the catheter causing urethral injury and subsequent urinary stricture. This study aims at observing the incidence of CRBD in oncological surgeries where multimodal analgesia approach is used for pain management. This study will also study the severity of CRBD as well as the reduction in severity of CRBD after any kind of intervention. Currently the benefits of various analgesia approaches and other measures to relieve the pain and discomfort related to indwelling urinary catheters are still under evaluation. Results from this study will provide a further insight to our understanding and help us change pain management protocols if found beneficial |