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?

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Buprenorphine; Drug: Oxycodone

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Vejle, Denmark, 7100
    • Orthopaedic Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Buprenorphine; Double dummy; Group A: Active Buprenorphine and placebo oxycodone	Drug: Buprenorphine; 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
Experimental: Oxycodone; Double Dummy: Group B: Placebo Buprenorphine and Active Oxycodone	Drug: Oxycodone; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Collaborators: Norpharma A/S
• Investigators: Study Director: Per Kjaersgaard-Andersen, MD, Orthopaedic Department, Vejle Hospital, Denmark

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: August 24, 2009
• First Submitted That Met QC Criteria: August 24, 2009
• First Posted (Estimate): August 25, 2009

Study Record Updates

• Last Update Posted (Estimate): December 8, 2014
• Last Update Submitted That Met QC Criteria: December 5, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Hip fractures; Treatment Outcome; Painkiller
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine; Oxycodone
• Other Study ID Numbers: EudraCT2009-010539-41