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CompletedNCT00784472Updated Jul 9, 2012

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

A Phase 3 interventional study of oxycodone and morphine in Kidney Stones, sponsored by Katja venborg Pedersen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-09.

Sponsored by Katja venborg Pedersen · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Kidney Stones

Keywords

  • PCNL
  • oxycodone
  • morphine
  • visceral pain
03

In context

Kidney Calculi

598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.

This study's enrollment of 55 is below the median of 90 across 461 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

This is the only study on the registry with Katja venborg Pedersen as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age > 18
  • Indication for PCNL

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
55 participants (actual)

Study arms

  • Active comparator
    oxycodone

    Drug: oxycodone

  • Active comparator
    morphine

    Drug: morphine

Interventions

  • Drugoxycodone

    intravenous according to patients weight, pn.

    Also known as: oxynorm N02A A05

  • Drugmorphine

    intravenous administration according to patients weight, pn.

    Also known as: morphine SAD N02 AA 01

06

What researchers measure

Primary outcomes

  1. Amount of analgetics used

    Time frame: four hours postoperatively

Secondary outcomes

  1. Side effects

    Time frame: four hours postoperatively

07

Study locations

1 site
  • Hospital Little Belt, Fredericia
    Fredericia, 7000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00784472
Lead sponsor
Katja venborg Pedersen
Collaborators
Aalborg University Hospital
Responsible party
Katja venborg Pedersen (MD, Fredericia Hosptial) — Sponsor-investigator
First posted
Nov 4, 2008
Start date
Dec 2008
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Jul 9, 2012

Study contacts

Palle Osther, Professor
study chair · Hospital Little Belt, Fredericia
katja Venborg Pedersen, MD
principal investigator · Hospital Little Belt, Fredericia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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