Pain, Postoperative | Norspan Versus Oxycontin as Postoperative Painkiller to Proximal Extracapsular Fractures of the Femur
Pain, Postoperative research study
What is the primary objective of this study?
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?
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:BuprenorphineStart: Day 0 (T=0), 10 micrograms/t until the day of discharge from the Hospital. New plaster at T= 7 days.
Drug:OxycodoneStart: 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
BuprenorphineDouble dummy; Group A: Active Buprenorphine and placebo oxycodone
OxycodoneDouble Dummy: Group B: Placebo Buprenorphine and Active Oxycodone
Start Date: September 2009
Completed Date: August 2013
Phase: Phase 4
Primary Outcome: Mobilization measured daily using Cumulated Ambulation Score.
Secondary Outcome: Pain intensity measured daily on a verbal rating scale
Study sponsors, principal investigator, and references
Principal Investigator: Per Kjaersgaard-Andersen, MD
Lead Sponsor: Vejle Hospital
Collaborator: Norpharma A/S