Prophylactic tramadol versus nefopam for post-operative catheter -related bladder discomfort in patients undergoing elective per-cutaneous nephrolithotomy

Completed

• Conditions: Pain management; Anaesthesiology - Pain management; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12618002054291
• Lead Sponsor: South valley university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-09-04
• Study Start: 2018-12-21
• Last Update Posted: 14 January 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

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 .

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Occurrence of catheter - related bladder discomfort<br>Which is being assessed by using a 4- point scale .[-Immediately after extubation (0 hr.).<br>-Thereafter at 1, 2 and 6 hours after operation ( primary time point).<br><br>]

Secondary Outcome Measures

Name	Time	Method
- Duration of effective post- operative analgesia, which is being assessed by using visual analogue scale( VAS). <br>-Effective: means the interval ( time period) between extubation and administration of 1 st rescue analgesic dose .<br>-The test used to determine this secondary outcome is visual analogue score .[-Immediately after extubation( 0 hr.).<br>-Thereafter at 1,2 and 6 hours after operation( secondary time point).]