| CTRI Number |
CTRI/2024/07/070516 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between TAPENTADOL and PREGABALIN for preventing catheter related bladder discomfort. |
|
Scientific Title of Study
|
Comparison Between Preemptive Oral Tapentadol Or Pregabalin For Attenuation Of Catheter Related Bladder Discomfort In Patients Undergoing Transurethral Resection Of Prostate : A Prospective, Randomised, Double Blind 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 |
S Ishwarya |
| Designation |
1st Year Postgraduate |
| Affiliation |
Sri Ramachandra Institute Of Higher Education and Research |
| Address |
Department of Anaesthesiology,Critical care and Pain Medicine,
Udayar A block 6th floor, G block 5th floor,
Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai - 600116
Department of Anaesthesiology,Critical care and Pain Medicine,
Udayar A block 6th floor, G block 5th floor,
Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai - 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9840042789 |
| Fax |
|
| Email |
ishwaryapims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumar Kodali |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education and Research |
| Address |
Department of Anaesthesiology,Critical care and Pain Medicine,
Udayar A block 6th floor, G block 5th floor,
Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai - 600116
Department of Anaesthesiology,Critical care and Pain Medicine,
Udayar A block 6th floor, G block 5th floor,
Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai - 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9962398266 |
| Fax |
|
| Email |
vrajeshkodali@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
S Ishwarya |
| Designation |
1st Year Postgraduate |
| Affiliation |
Sri Ramachandra Institute Of Higher Education and Research |
| Address |
Department of Anaesthesiology,Critical care and Pain Medicine,
Udayar A block 6th floor, G block 5th floor,
Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai
Department of Anaesthesiology,Critical care and Pain Medicine,
Udayar A block 6th floor, G block 5th floor,
Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai - 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9840042789 |
| Fax |
|
| Email |
ishwaryapims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116 |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology,Critical care and Pain Medicine,
Udayar A block 6th floor, G block 5th floor,
Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai - 600116 |
| Type of Sponsor |
Private 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 S Ishwarya |
Sri Ramachandra Institute Of Higher Education and Research |
Department of Anaesthesiology,Critical care and Pain Medicine,
Udayar A block 6th floor, G block 5th floor,
Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai - 600116
Chennai
TAMIL NADU |
9840042789
ishwaryapims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SRU |
Submittted/Under Review |
| Institutional Research Ethics Committee, (For PG students of Medical college), Sri Ramachandra Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
T. PREGABALIN 75mg |
Dose : 75mg, per oral, stat dose, to be given 1 hour postoperatively with sips of water. Patient will be monitored for symptoms of CRBD for 24 hours from the time medication was given. |
| Intervention |
T. TAPENTADOL 50mg |
Dose : 50mg, per oral, stat dose, to be given 1 hour postoperatively with sips of water. Patient will be monitored for symptoms of CRBD for 24 hours from the time medication was given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
Male
Age 18 to 80 years
ASA I , II , III
Undergoing Elective Transurethral resection of Prostate under Regional anaesthesia
Requiring bladder catheterization |
|
| ExclusionCriteria |
| Details |
ASA IV patients
Contraindication for spinal anaesthesia
Significant cardiac disease
Chronic analgesic use
High AV Block
Psychiatric disease
Renal failure
Paralytic ileus
History of urinary tract obstruction/neurogenic/ overactive bladder
Acute exacerbation of Bronchial Asthma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence of postoperative Catheter Related Bladder Discomfort. |
0 minutes
30 minutes
1st hour
2nd hour
4th hour
8th hour
12th hour
24th hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Need for additional analgesic.
Assess any adverse effects including postoperative nausea and vomiting, respiratory depression, sedation, drowsiness, confusion and dry mouth. |
0 minutes
30 minutes
1st hour
2nd hour
4th hour
8th hour
12th hour
24th hour |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/07/2024 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ishwaryapims@gmail.com].
- For how long will this data be available start date provided 12-07-2025 and end date provided 12-12-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
CRBD is caused by catheter-induced bladder irritation due to muscarinic receptor-mediated involuntary contractions of the bladder smooth muscle.
Despite the various treatment and prevention options for catheter-related bladder discomfort (CRBD), many uncertainties persist in clinical practice.
Catheter related bladder discomfort being a post catheterization complication has an incidence of 47-90%. This study evaluates the efficacy of preoperative oral Tapentadol or Pregabalin in decreasing the incidence of postoperative catheter-related bladder discomfort in patients undergoing Transurethral Resection of Prostate under Spinal Anaesthesia.
Hence, we are comparing between pre-emptive oral Tapentadol 50 mg or Pregabalin 75 mg for attenuation of Catheter Related Bladder Discomfort in patients undergoing Transurethral Resection of Prostate under Spinal Anaesthesia.
Secondary outcome for this study is also being assessed such as the need for additional analgesic and to assess any adverse effects including postoperative nausea and vomiting, respiratory depression, sedation, drowsiness, confusion and dry mouth.
|