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

This study has been completed.
Sponsor:
Collaborator:
Aalborg Universityhospital
Information provided by (Responsible Party):
Katja venborg Pedersen, Fredericia Hosptial
ClinicalTrials.gov Identifier:
NCT00784472
First received: October 27, 2008
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Kidney Stones
Drug: oxycodone
Drug: morphine
Phase 3

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Fredericia Hosptial:

Primary Outcome Measures:
  • Amount of analgetics used [ Time Frame: four hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effects [ Time Frame: four hours postoperatively ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: December 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784472

Locations
Denmark
Hospital Little Belt, Fredericia
Fredericia, Denmark, 7000
Sponsors and Collaborators
Katja venborg Pedersen
Aalborg Universityhospital
Investigators
Study Chair: Palle Osther, Professor Hospital Little Belt, Fredericia
Principal Investigator: katja Venborg Pedersen, MD Hospital Little Belt, Fredericia
  More Information

No publications provided

Responsible Party: Katja venborg Pedersen, MD, Fredericia Hosptial
ClinicalTrials.gov Identifier: NCT00784472     History of Changes
Other Study ID Numbers: VEN 1
Study First Received: October 27, 2008
Last Updated: July 5, 2012
Health Authority: Denmark: National Board of Health

Keywords provided by Fredericia Hosptial:
PCNL
oxycodone
morphine
visceral pain

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Visceral Pain
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Nociceptive Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014