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OpenTrials
Completed

NCT Number: NCT00964808

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

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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Orthopaedic Department

Vejle, 7100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buprenorphine

Drug

Start: Day 0 (T=0), 10 micrograms/t until the day of discharge from the Hospital. New plaster at T= 7 days.

Other names: Norspan

Oxycodone

Drug

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.

Other names: Oxycontin

Primary outcomes

  1. Mobilization measured daily using Cumulated Ambulation Score.

    Time frame: 12 days

Secondary outcomes

  1. Pain intensity measured daily on a verbal rating scale

    Time frame: 12 days

  2. Adverse effects

    Time frame: 12 days + 14 days

  3. Opioid consumption.

    Time frame: 12 days

  4. Length of stay in Hospital

    Time frame: Untill discharge

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Collaborators

  • Norpharma A/S

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Aug 25, 2009
Registry last updated
Dec 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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