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

NCT ID: NCT00964808

Last Updated: 2014-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-08-31

Brief Summary

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?

Conditions

Pain, Postoperative

Keywords

Hip fractures; Treatment Outcome; Painkiller

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Buprenorphine

Double dummy; Group A: Active Buprenorphine and placebo oxycodone

Group Type: EXPERIMENTAL

Buprenorphine

Intervention Type: DRUG

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

Oxycodone

Double Dummy:

Group B: Placebo Buprenorphine and Active Oxycodone

Group Type: EXPERIMENTAL

Oxycodone

Intervention Type: 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.

Interventions

Buprenorphine

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Norspan; Oxycontin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norpharma A/S

INDUSTRY

Sponsor Role: collaborator

Vejle Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per Kjaersgaard-Andersen, MD

Role: STUDY_DIRECTOR

Orthopaedic Department, Vejle Hospital, Denmark

Locations

Orthopaedic Department

Vejle, , Denmark

Countries

Denmark

Other Identifiers

EudraCT2009-010539-41

Identifier Type: -

Identifier Source: org_study_id