Pain, Postoperative
Conditions
Keywords
Hip fractures, Treatment Outcome, Painkiller
Brief 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?
Interventions
DRUGBuprenorphine
Start: Day 0 (T=0), 10 micrograms/t until the day of discharge from the Hospital. New plaster at T= 7 days.
DRUGOxycodone
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.
Sponsors
Norpharma A/S
Vejle Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mobilization measured daily using Cumulated Ambulation Score. | 12 days |
Secondary
| Measure | 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 |
Countries
Denmark
Outcome results
None listed