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

Condition(s) targeted: Pain, Postoperative

Intervention: Buprenorphine (Drug); Oxycodone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Vejle Hospital

Official(s) and/or principal investigator(s):
Per Kjaersgaard-Andersen, MD, Study Director, Affiliation: Orthopaedic Department, Vejle Hospital, Denmark

Overall contact:
Per Kjaersgaard-Andersen, MD, Phone: +45 79405716, Email: per.kjaersgaard-andersen@slb.regionsyddanmark.dk

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Mobilization measured daily using Cumulated Ambulation Score.

Secondary outcome:

Pain intensity measured daily on a verbal rating scale

Adverse effects

Opioid consumption.

Length of stay in Hospital

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Per Kjaersgaard-Andersen, MD, Phone: +45 79405716, Email: per.kjaersgaard-andersen@slb.regionsyddanmark.dk

Orthopaedic Department, Vejle 7100, Denmark; Recruiting
Per Kjaersgaard-Andersen, MD, Phone: +4579405716, Email: per.kjaersgaard-andersen@slb.regionsyddanmark.dk
Kirsten Specht, RN, Phone: +4579405757, Email: kirsten.specht@slb.regionsyddanmark.dk
Per Kjaersgaard-Andersen, MD, Principal Investigator

Starting date: September 2009
Ending date: October 2010
Last updated: October 16, 2009