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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02516059 |
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Date of registration:
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03/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Early Postoperative Administration of Oxycodone +/- Naloxone and Duration of Epidural Analgesia
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Scientific title:
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Does Postoperative Administration of Oral Oxycodone With/Without Naloxone, Reduce the Duration of Epidural Analgesia in Patients Undergoing Cystectomy Without Impairing Its Benefits? A Randomized, Double Blind Controlled Trial |
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Date of first enrolment:
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September 14, 2015 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02516059 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Patrick Y Wuethrich, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Anaesthesiology and Pain Therapy, University Hospital Bern |
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Name:
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Fiona C Burkhard, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Urology, University Hospital Bern |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- At least 18 years old
- Informed Consent as documented by signature
- Renal function: eGFR >40ml/min
- Normal liver function
- Cystectomy with urinary diversion
- Use of thoracic epidural analgesia
Exclusion Criteria
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or
allergy to class of drugs or the investigational product, i.e. known allergy to
oxycodone naloxone or other excipients
- Women who are pregnant or breast feeding, (exclusion for surgery per se)
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, severe psychiatric disorder, etc. of the
participant
- Severe asthma bronchiale, severe COPD
- Severe respiratory depression with hypoxia and/or hypercapnoea, cor pulmonale
- Preoperative use of MAO-Inhibitors (or has to be stopped 2 weeks before surgery)
- Patients with chronic pain
- Patients with regular use of antiemetics, laxatives, opioids or other types of
analgesics
- Preoperative regular use of non steroidal anti inflammatory drugs and steroids
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Postoperative Pain Management
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Epidural Analgesia
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Radical Cystectomy
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Oral Oxycodone With/Without Naloxone
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Return of the Bowel Function
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Intervention(s)
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Drug: oxycodone/naloxone
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Device: epidural catheter
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Drug: Oxycodone
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Drug: Placebo
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Primary Outcome(s)
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Length of stay of the epidural catheter in days
[Time Frame: At removal of the catheter, expected to be on average of 6 days]
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Secondary Outcome(s)
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Pain scores (NRS 0-10) at postoperative day (POD) 1 to POD 7
[Time Frame: From postoperative day (POD) 1 to 7]
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Duration of the return of the bowel function in days
[Time Frame: From postoperative day (POD) 1 to 7]
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Secondary ID(s)
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2015DR4112
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068/15
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WUPD 01-14
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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