Visceral Pain From the Upper Urinary Tract - a Trial on the Effect of Morphine and Oxycodone in Patients Undergoing PCNL

Kidney Stones Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784472
• Other study ID #: VEN 1
• Status: Completed
• Phase: Phase 3
• First received: October 27, 2008
• Last updated: July 5, 2012
• Start date: December 2008
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Fredericia Hosptial
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18

• Indication for PCNL

Exclusion Criteria:

• Malignant disease in the upper urinary tract

• Allergy to morphine or oxycodone

• Use of opioids the last 48 hours before PCNL

• Pregnancy

• Nursing mothers

• Present JJ-stent in the ureter

• Previous urinary stone disease on the opposite site

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stones
• Nephrolithiasis
• Visceral Pain

Intervention

Drug:
• oxycodone
intravenous according to patients weight, pn.
• morphine
intravenous administration according to patients weight, pn.

Locations

Country	Name	City	State
Denmark	Hospital Little Belt, Fredericia	Fredericia

Sponsors (2)

Lead Sponsor	Collaborator
Katja venborg Pedersen	Aalborg Universitetshospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of analgetics used		four hours postoperatively	No
Secondary	Side effects		four hours postoperatively	No