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

Katja venborg Pedersen

Status and phase: Completed; Phase 3

Conditions: Kidney Stones

Treatments: Drug: oxycodone; Drug: morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT00784472

VEN 1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

55 participants in 2 patient groups

oxycodone

Active Comparator group

Treatment:

Drug: oxycodone

morphine

Active Comparator group

Treatment:

Drug: morphine