search
Back to results

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

Primary Purpose

Kidney Stones

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
oxycodone
morphine
Sponsored by
Katja venborg Pedersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stones focused on measuring PCNL, oxycodone, morphine, visceral pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Little Belt, Fredericia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

oxycodone

morphine

Arm Description

Outcomes

Primary Outcome Measures

Amount of analgetics used

Secondary Outcome Measures

Side effects

Full Information

First Posted
October 27, 2008
Last Updated
July 5, 2012
Sponsor
Katja venborg Pedersen
Collaborators
Aalborg University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00784472
Brief Title
Visceral Pain From the Upper Urinary Tract - a Trial on the Effect of Morphine and Oxycodone in Patients Undergoing PCNL
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Katja venborg Pedersen
Collaborators
Aalborg University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stones
Keywords
PCNL, oxycodone, morphine, visceral pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oxycodone
Arm Type
Active Comparator
Arm Title
morphine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
oxycodone
Other Intervention Name(s)
oxynorm N02A A05
Intervention Description
intravenous according to patients weight, pn.
Intervention Type
Drug
Intervention Name(s)
morphine
Other Intervention Name(s)
morphine SAD N02 AA 01
Intervention Description
intravenous administration according to patients weight, pn.
Primary Outcome Measure Information:
Title
Amount of analgetics used
Time Frame
four hours postoperatively
Secondary Outcome Measure Information:
Title
Side effects
Time Frame
four hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Palle Osther, Professor
Organizational Affiliation
Hospital Little Belt, Fredericia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
katja Venborg Pedersen, MD
Organizational Affiliation
Hospital Little Belt, Fredericia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Little Belt, Fredericia
City
Fredericia
ZIP/Postal Code
7000
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs