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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00964808
First Posted: August 25, 2009
Last Update Posted: December 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Norpharma A/S
Information provided by (Responsible Party):
Vejle Hospital
  Purpose

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?


Condition Intervention Phase
Pain, Postoperative Drug: Buprenorphine Drug: Oxycodone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Norspan Versus Oxycontin as Postoperative Painkiller to Proximal Extracapsular Fractures of the Femur

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Mobilization measured daily using Cumulated Ambulation Score. [ Time Frame: 12 days ]

Secondary Outcome Measures:
  • Pain intensity measured daily on a verbal rating scale [ Time Frame: 12 days ]
  • Adverse effects [ Time Frame: 12 days + 14 days ]
  • Opioid consumption. [ Time Frame: 12 days ]
  • Length of stay in Hospital [ Time Frame: Untill discharge ]

Enrollment: 76
Study Start Date: September 2009
Study Completion Date: August 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Oxycontin

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964808


Locations
Denmark
Orthopaedic Department
Vejle, Denmark, 7100
Sponsors and Collaborators
Vejle Hospital
Norpharma A/S
Investigators
Study Director: Per Kjaersgaard-Andersen, MD Orthopaedic Department, Vejle Hospital, Denmark
  More Information

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT00964808     History of Changes
Other Study ID Numbers: EudraCT2009-010539-41
First Submitted: August 24, 2009
First Posted: August 25, 2009
Last Update Posted: December 8, 2014
Last Verified: December 2014

Keywords provided by Vejle Hospital:
Hip fractures
Treatment Outcome
Painkiller

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Buprenorphine
Oxycodone
Analgesics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists


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