NCT02516059 - Early Postoperative Administration of Oxycodone +/- Naloxone and Duration of Epidural Analgesia | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 14, 2015

Primary Completion Date

February 20, 2017

Study Completion Date

February 28, 2017

Conditions

Postoperative Pain ManagementRadical CystectomyEpidural AnalgesiaOral Oxycodone With/Without NaloxoneReturn of the Bowel Function

Interventions

DRUG

oxycodone/naloxone

Oxycodone and naloxone (Targin®; Mundipharma Medical Company and Mundipharma Research GmbH \& Co Basel, Switzerland): Will be orally administered at 12 hours intervals, starting with 10mg/5mg on POD 3 and move to 20mg/10mg the other day.

DRUG

Oxycodone

Oxycodone (Oxycontin®, Mundipharma Medical Company and Mundipharma Research GmbH \& Co Basel, Switzerland): Will be orally administered at 12 hours intervals, starting with 10 mg on POD 3 and move to 20 mg the other day.

DRUG

Placebo

Placebo (Mundipharma Medical Company and Mundipharma Research GmbH \& Co Basel, Switzerland): Will be orally administered at 12 hours intervals starting on POD 3.

DEVICE

epidural catheter

Trial Locations (1)

3010

Dep of Urology Bern University Hospital, Bern

All Listed Sponsors

lead

Insel Gruppe AG, University Hospital Bern

OTHER