Norspan Versus Oxycontin as Postoperative Painkiller to Proximal Extracapsular Fractures of the Femur

Pain, Postoperative Clinical Trial

Official title:

Norspan Versus Oxycontin as Postoperative Painkiller to Proximal Extracapsular Fractures of the Femur

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964808
• Other study ID #: EudraCT2009-010539-41
• Status: Completed
• Phase: Phase 4
• First received: August 24, 2009
• Last updated: December 5, 2014
• Start date: September 2009
• Est. completion date: August 2013

Study information

• Verified date: December 2014
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

Effective treatment of pain after hip fractures is very important but difficult. It is often an old patient who has many adverse effects with the use of morphine.

This is a randomized pilot study where the investigators want to compare Norspan plaster to Oxycontin tablets to patients with particular kind of hip fractures. The investigators will evaluate mobilization, pain, use of rescue medicine, adverse effects and length of stay. No clinical study about the effect of Norspan as acute painkiller has never been done before. Can the investigators get the patients mobilized earlier with less adverse effects?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and females age 18 years or more

• X-ray confirming basicervical, pertrochanteric or subtrochanteric femur fracture and planning operation with DHS or PFN.

• Subjects must have 7 or more points in the Hindsøes test.

Exclusion Criteria:

• Subjects where spinal anaesthesia cannot be applied.

• Subject in Plavix® treatment seven days before admission to the hospital.

• Subjects with extracapsular hip fracture due to bone metastasis.

• Subjects with a BMI over 30.

• Subjects under 45 kg.

• Subjects who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 2 weeks prior admission to the hospital.

• Substance or alcohol abuse, or subjects who, in the opinion of the investigator have demonstrated addictive or substance abuse behavior.

• Untreated depression or other psychiatric disorder in such a way that participation in the study may in the opinion of the investigator pos an unacceptable risk to the subject.

• Dermatological disorder at any relevant patch application site.

• Any contraindications listed in the Summary of Product Characteristics for Norspan®, OxyNorm® and OxyContin®.

• Patient does not tolerate oxynorm.

• User of wheelchair.

• Daily use of morphine before hospitalization.

• More than one fracture. Patients with myasthenia gravis. Patients with severe respiratory function. Patients know need re-operation women of childbearing potential must have a negative pregnancy test and be non-lactating

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Buprenorphine
Start: Day 0 (T=0), 10 micrograms/t until the day of discharge from the Hospital. New plaster at T= 7 days.
• Oxycodone
Start: 10 hours (+/- 2 hours) after the operation. Dosage: 10 mg * 2 pr. day until time to discharge from the Hospital or latest at day 12.

Locations

Country	Name	City	State
Denmark	Orthopaedic Department	Vejle

Sponsors (2)

Lead Sponsor	Collaborator
Vejle Hospital	Norpharma A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mobilization measured daily using Cumulated Ambulation Score.		12 days	No
Secondary	Pain intensity measured daily on a verbal rating scale		12 days	No
Secondary	Adverse effects		12 days + 14 days	No
Secondary	Opioid consumption.		12 days	No
Secondary	Length of stay in Hospital		Untill discharge	No