A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy

Ullevaal University Hospital1 site in 1 country85 target enrollmentMarch 1, 2010

Overview

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:

Registry

clinicaltrials.gov

Start Date

March 1, 2010

End Date

July 30, 2011

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Sponsor

Ullevaal University Hospital

Responsible Party

Principal Investigator

Johan C Ræder

Professor

Oslo University Hospital

•Females 18 -70 years
•Elective, non-malignant laparoscopic gynecological surgery in general anesthesia : hysterectomy/ myomectomy, ASA 1, 2 and 3
•Subjects willing and able to participate the study and have provided informed consent form -

•Previous recent or regular opioid use (WHO step I pain treatment allowed)
•Any situation where opioids are contraindicated.
•Any history of moderate to severe hepatic impairment.
•Any history of severe respiratory depression with hypoxia and/or hypercapnia
•Any history of severe chronic obstructive pulmonary disease, cor pulmonal, acute severe bronchial asthma
•Subjects with evidence of non-opioid induced paralytic ileus
•Subjects with evidence of severely impaired pulmonary function, myxoedema, hypothyroidism
•Subjects with evidence of Addison's disease (adrenal cortical insufficiency), toxic psychosis,cholelithiasis, prostate hypertrophy, alcoholism, delirium, pancreatitis, hypotension, hypertension, pre-existing cardiovascular diseases, head injury (due to the risk of increased intracranial pressure), epileptic disorder or predisposition to convulsions, or patients taking MAO inhibitors.
•Any history of hypersensitivity to Oxycodone / Naloxone or to any of the excipients.
•Active alcohol or drug abuse and/or history of opioid abuse.