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

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)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00784472
Enrollment
55
Registered
2008-11-04
Start date
2008-12-31
Completion date
2012-06-30
Last updated
2012-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Stones

Keywords

PCNL, oxycodone, morphine, visceral pain

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.

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.

Interventions

DRUGoxycodone

intravenous according to patients weight, pn.

DRUGmorphine

intravenous administration according to patients weight, pn.

Sponsors

Aalborg University Hospital
CollaboratorOTHER
Katja venborg Pedersen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Amount of analgetics usedfour hours postoperatively

Secondary

MeasureTime frame
Side effectsfour hours postoperatively

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026