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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00784472
Recruitment Status : Completed
First Posted : November 4, 2008
Last Update Posted : July 9, 2012
Aalborg University Hospital
Information provided by (Responsible Party):
Katja venborg Pedersen, Fredericia Hosptial

Brief 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.

Condition or disease Intervention/treatment Phase
Kidney Stones Drug: oxycodone Drug: morphine Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : December 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: oxycodone Drug: oxycodone
intravenous according to patients weight, pn.
Other Name: oxynorm N02A A05

Active Comparator: morphine Drug: morphine
intravenous administration according to patients weight, pn.
Other Name: morphine SAD N02 AA 01

Primary Outcome Measures :
  1. Amount of analgetics used [ Time Frame: four hours postoperatively ]

Secondary Outcome Measures :
  1. Side effects [ Time Frame: four hours postoperatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00784472

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Hospital Little Belt, Fredericia
Fredericia, Denmark, 7000
Sponsors and Collaborators
Katja venborg Pedersen
Aalborg University Hospital
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Study Chair: Palle Osther, Professor Hospital Little Belt, Fredericia
Principal Investigator: katja Venborg Pedersen, MD Hospital Little Belt, Fredericia
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Responsible Party: Katja venborg Pedersen, MD, Fredericia Hosptial Identifier: NCT00784472    
Other Study ID Numbers: VEN 1
First Posted: November 4, 2008    Key Record Dates
Last Update Posted: July 9, 2012
Last Verified: July 2012
Keywords provided by Katja venborg Pedersen, Fredericia Hosptial:
visceral pain
Additional relevant MeSH terms:
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Kidney Calculi
Visceral Pain
Kidney Diseases
Urologic Diseases
Urinary Calculi
Pathological Conditions, Anatomical
Nociceptive Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents