Norspan Versus Oxycontin as Postoperative Painkiller to Proximal Extracapsular Fractures of the Femur - Full Text View

Sponsor:	Vejle Hospital
Collaborator:	Norpharma A/S
Information provided by (Responsible Party):	Lena Schroll, Vejle Hospital
ClinicalTrials.gov Identifier:	NCT00964808

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Fractures Hip Injuries and Disorders

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Oxycodone Oxycodone hydrochloride

U.S. FDA Resources

Further study details as provided by Vejle Hospital:

Primary Outcome Measures:

Mobilization measured daily using Cumulated Ambulation Score. [ Time Frame: 12 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain intensity measured daily on a verbal rating scale [ Time Frame: 12 days ] [ Designated as safety issue: No ]
Adverse effects [ Time Frame: 12 days + 14 days ] [ Designated as safety issue: No ]
Opioid consumption. [ Time Frame: 12 days ] [ Designated as safety issue: No ]
Length of stay in Hospital [ Time Frame: Untill discharge ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	September 2009
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	September 2012 (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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964808

Contacts

Contact: Per Kjaersgaard-Andersen, MD	+45 79405716	per.kjaersgaard-andersen@slb.regionsyddanmark.dk
Contact: Lena Schroll, MD	+45 79405767	lena.schroll@slb.regionsyddanmark.dk

Locations

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

Sponsors and Collaborators

Vejle Hospital

Norpharma A/S

Investigators

Study Director:

Per Kjaersgaard-Andersen, MD

Orthopaedic Department, Vejle Hospital, Denmark

More Information

No publications provided

Responsible Party:	Lena Schroll, Concultant, Vejle Hospital
ClinicalTrials.gov Identifier:	NCT00964808 History of Changes
Other Study ID Numbers:	EudraCT2009-010539-41
Study First Received:	August 24, 2009
Last Updated:	December 6, 2011
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency

Keywords provided by Vejle Hospital:

Hip fractures
Treatment Outcome
Painkiller

Additional relevant MeSH terms:

Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Buprenorphine
Oxycodone
Analgesics, Opioid
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012