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

Study Overview
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Brief Summary
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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?

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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Buprenorphine
* Drug: Oxycodone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buprenorphine<br>Double dummy; Group A: Active Buprenorphine and placebo oxycodone | Drug: Buprenorphine<br>* Start: Day 0 (T=0), 10 micrograms/t until the day of discharge from the Hospital. New plaster at T= 7 days.<br>* Other names: Norspan;|
| Experimental: Oxycodone<br>Double Dummy: Group B: Placebo Buprenorphine and Active Oxycodone | Drug: Oxycodone<br>* 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.<br>* Other names: Oxycontin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobilization measured daily using Cumulated Ambulation Score. |  | 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity measured daily on a verbal rating scale |  | 12 days | 
| Adverse effects |  | 12 days + 14 days | 
| Opioid consumption. |  | 12 days | 
| Length of stay in Hospital |  | Untill discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip fractures, Treatment Outcome, Painkiller