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Completed

NCT Number: NCT00784472

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.

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Key information

Conditions

Kidney Stones Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Neurologic Manifestations Nociceptive Pain Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases Visceral Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Little Belt, Fredericia

Fredericia, 7000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycodone

Drug

intravenous according to patients weight, pn.

Other names: oxynorm N02A A05

Morphine

Drug

intravenous administration according to patients weight, pn.

Other names: morphine SAD N02 AA 01

Primary outcomes

  1. Amount of analgetics used

    Time frame: four hours postoperatively

Secondary outcomes

  1. Side effects

    Time frame: four hours postoperatively

Sponsors and collaborators

Lead sponsor

Katja venborg Pedersen

Other

Collaborators

  • Aalborg University Hospital

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Nov 4, 2008
Registry last updated
Jul 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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