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Trial registered on ANZCTR


Registration number
ACTRN12618002054291
Ethics application status
Approved
Date submitted
5/12/2018
Date registered
21/12/2018
Date last updated
21/12/2018
Date data sharing statement initially provided
21/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prophylactic tramadol versus nefopam for post-operative catheter -related bladder discomfort in patients undergoing elective per-cutaneous nephrolithotomy
Scientific title
Prophylactic tramadol versus nefopam for post-operative catheter-related bladder discomfort in patients undergoing elective per-cutaneous nephrolithotomy.A randomized controlled trial
Secondary ID [1] 296278 0
None
Universal Trial Number (UTN)
Trial acronym
T vs. N in PCNL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain management 310714 0
Condition category
Condition code
Anaesthesiology 308725 308725 0 0
Pain management
Renal and Urogenital 309413 309413 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 groups are included in which a total volume of 10 ml. Isotonic saline ( 0.9%) are given slow intravenously (Over 1 min.) 30 min. Before expected extubation
Group I: tramadol group received 1.5 mg/kg tramadol diluted in 10 ml. Isotonic saline ( 1 min. Duration)
Group II: nefopam group received 0.15 mg/kg nefopam diluted in 10 ml.isotonic saline(1 min. duration)
Group III: control group received isotonic saline 10 ml. (1min. duration).
Intervention code [1] 312608 0
Treatment: Drugs
Comparator / control treatment
Tramadol group is being compared to nefopam group and placebo group in PCNL
Control group
Placebo

Outcomes
Primary outcome [1] 307705 0

Occurrence of catheter - related bladder discomfort
Which is being assessed by using a 4- point scale .
Timepoint [1] 307705 0
-Immediately after extubation (0 hr.).
-Thereafter at 1, 2 and 6 hours after operation ( primary time point).
Secondary outcome [1] 352588 0
- Duration of effective post- operative analgesia, which is being assessed by using visual analogue scale( VAS).
-Effective: means the interval ( time period) between extubation and administration of 1 st rescue analgesic dose .
-The test used to determine this secondary outcome is visual analogue score .
Timepoint [1] 352588 0
-Immediately after extubation( 0 hr.).
-Thereafter at 1,2 and 6 hours after operation( secondary time point).

Eligibility
Key inclusion criteria
adult patients of either sex, ASA I or II, undergoing per cutaneous nephrolithotomy(PCNL) for renal upper ureteric stone requiring catheterization of urinary bladder . This procedure usually requires postoperative bladder drainage for 12-24 hours in addition to nephrostomy .
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Bladder outflow obstruction.
-Overactive bladder( frequency > 3 times per night or mor than 8 times per 24 hours.
-Epilepsy.
-Myocardial ischemia or infarction , arrhythmia so, heart failure.
-Renal and hepatic diseases .
-Current use of mono amine oxidase inhibitors.
-History of drug abuse.
-Angle- closure glaucoma.
-Morbid obesity( BMI> 30 kg/ m2).
- History of chronic pain.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2017
Date of last participant enrolment
Anticipated
Actual
2/07/2018
Date of last data collection
Anticipated
Actual
4/09/2018
Sample size
Target
150
Accrual to date
Final
150
Recruitment outside Australia
Country [1] 20905 0
Egypt
State/province [1] 20905 0

Funding & Sponsors
Funding source category [1] 301299 0
University
Name [1] 301299 0
South valey university
Country [1] 301299 0
Egypt
Primary sponsor type
University
Name
South valley university
Address
Qena, Nqada, 6thkilometer of Qena- Safagah road, Qena governerate, postal code 83423
Country
Egypt
Secondary sponsor category [1] 300951 0
None
Name [1] 300951 0
Address [1] 300951 0
Country [1] 300951 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302040 0
Qena university hospitals
Ethics committee address [1] 302040 0
Ethics committee country [1] 302040 0
Egypt
Date submitted for ethics approval [1] 302040 0
23/05/2017
Approval date [1] 302040 0
01/06/2017
Ethics approval number [1] 302040 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51530 0
A/Prof Hatem saber Mohamed
Address 51530 0
37 mustsharen street, Mubarak city, Mansoura city , Dakahleya governerate- postal code 35511,Qena faculty of medicine, south valley university.
Country 51530 0
Egypt
Phone 51530 0
+201005257062
Fax 51530 0
Email 51530 0
dr.hatem_saber@hotmail.com
Contact person for public queries
Name 51531 0
Hatem saber Mohamed
Address 51531 0
37 mustsharen street, Mubarak city, Mansoura city , Dakahleya governerate- postal code 35511,Qena faculty of medicine, south valley university.
Country 51531 0
Egypt
Phone 51531 0
+201005257062
Fax 51531 0
Email 51531 0
dr.hatem_saber@hotmail.com
Contact person for scientific queries
Name 51532 0
Hatem saber Mohamed
Address 51532 0
37 mustsharen street, Mubarak city, Mansoura city , Dakahleya governerate- postal code 35511,Qena faculty of medicine, south valley university.
Country 51532 0
Egypt
Phone 51532 0
+201005257062
Fax 51532 0
Email 51532 0
dr.hatem_saber@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIProphylactic Tramadol versus Nefopam for Post-operative Catheter-Related Bladder Discomfort in Patients Undergoing Elective Percutaneous Nephrolithotomy: Randomized Controlled Trial2022https://doi.org/10.21608/ejhm.2022.266027
N.B. These documents automatically identified may not have been verified by the study sponsor.