The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date results information 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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Address [1] 301299 0
Qena, Nqada, 6 th kilometer of Qena- Safagah road, Qena governerate, postal address 83523
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
Qena, Nqada,6 th kilometer of Qena- Safagah road, Qena governerate, postal code 83523
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
This study is conducted to compare the administration of iv tramadol and nefopam for prophylactic treatment of catheter related bladder discomfort for patients undergoing elective per cutaneous nephrolithotomy
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
A/Prof 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
A/Prof 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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary