Visceral Pain From the Upper Urinary Tract - a Trial on the Effect of Morphine and Oxycodone in Patients Undergoing PCNL
The purpose of this study is to investigate the effect of oxynorm versus morphine after operation for kidney stone (PCNL). In addition the relationship between pain symptoms and referred sensory and trophic changes will be examined in the patients before and after the operation.Finally a blood sample is analysed to investigate pharmaca-genetics.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Visceral Pain Originating From the Upper Urinary Tract - a Randomized Controlled Trial on the Effect of Morphine and Oxycodone in Patients Undergoing Percutaneous Nephrolithotomy (PCNL)|
- Amount of analgetics used [ Time Frame: four hours postoperatively ] [ Designated as safety issue: No ]
- Side effects [ Time Frame: four hours postoperatively ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: oxycodone||
intravenous according to patients weight, pn.
Other Name: oxynorm N02A A05
|Active Comparator: morphine||
intravenous administration according to patients weight, pn.
Other Name: morphine SAD N02 AA 01
Primary outcome: the amount of opioid (morphine or oxynorm) used the first 4 hours postoperatively.
Secondary outcome: side effect to the opioids, pain score, pain threshold to electrical stimulation and pressure before and after operation, pharmacogenetics, size of referred pain area.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784472
|Hospital Little Belt, Fredericia|
|Fredericia, Denmark, 7000|
|Study Chair:||Palle Osther, Professor||Hospital Little Belt, Fredericia|
|Principal Investigator:||katja Venborg Pedersen, MD||Hospital Little Belt, Fredericia|