A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy

Summary

Objectives: Primary objective: * To demonstrate that the treatment with OXN PR tablets up to 72 hrs after surgery is superior to the treatment with OxyPR with regards to constipation in subjects with postoperative pain after laparoscopic hysterectomy based on interviews 24h, 72 h and 1 week postoperatively. The secondary objectives: * Analgesic effect (including registration during the first 24 hrs) * To asses the frequency of pain rescue mediation use (in the double-blind phase, 0-72 hrs) * Frequency of nausea and vomiting * Frequency of other adverse events * Appetite * Mobilization The exploratory objectives: * Overall patient satisfaction at 24, 72 hrs and 1 week

Timeline

Start

2010-03-01

Primary completion

2011-06-30

Completion

2011-07-30

Drugs

Indications