A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy

Phase 4

Completed

• Conditions: Postoperative Pain; Opioid Induced Constipation
• Interventions: Drug: oxycodone; Drug: naloxone

• Registration Number: NCT01109511
• Lead Sponsor: Ullevaal University Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-01
• Study First Submitted: 2010-04-15
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-23
• Primary Completion: 2011-06-30
• Study Completion: 2011-07-30
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-01
• Last Update Posted: 2018-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 85

Inclusion Criteria

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

Exclusion Criteria

1. Previous recent or regular opioid use (WHO step I pain treatment allowed)
2. Any situation where opioids are contraindicated.
3. Any history of moderate to severe hepatic impairment.
4. Any history of severe respiratory depression with hypoxia and/or hypercapnia
5. Any history of severe chronic obstructive pulmonary disease, cor pulmonal, acute severe bronchial asthma
6. Subjects with evidence of non-opioid induced paralytic ileus
7. Subjects with evidence of severely impaired pulmonary function, myxoedema, hypothyroidism
8. 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.
9. Any history of hypersensitivity to Oxycodone / Naloxone or to any of the excipients.
10. Active alcohol or drug abuse and/or history of opioid abuse.
11. Subjects with evidence of clinically unstable disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination that, in the Investigator's opinion, preclude entry into the study.
12. Subjects who have received an investigational medicinal product within 30 days of study entry (defined as the start of the Screening Period).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	oxycodone	Oxycodone alone without naloxone
oxycodone+naloxone	naloxone	-
oxycodone+naloxone	oxycodone	-

Primary Outcome Measures

Name	Time	Method
Constipation in subjects with postoperative pain	3 days

Trial Locations

Locations (1)

Dept of Anesthesiology, Oslo University Hospital, Ullevaal; 🇳🇴 Oslo, Norway