NCT01109511

A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Ullevaal University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Postoperative Pain
• Opioid Induced Constipation

Interventions

Type	Name	Description
DRUG	naloxone
DRUG	oxycodone

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-06-30
• Completion: 2011-07-30
• First posted: 2010-04-23
• Last updated: 2018-11-05

Locations

1 site across 1 country: Norway