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

Primary Purpose

Pain, Postoperative

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Buprenorphine

Oxycodone

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Hip fractures, Treatment Outcome, Painkiller

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Orthopaedic Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Buprenorphine

Oxycodone

Arm Description

Double dummy; Group A: Active Buprenorphine and placebo oxycodone

Double Dummy: Group B: Placebo Buprenorphine and Active Oxycodone

Outcomes

Primary Outcome Measures

Mobilization measured daily using Cumulated Ambulation Score.

Secondary Outcome Measures

Pain intensity measured daily on a verbal rating scale

Adverse effects

Opioid consumption.

Length of stay in Hospital

Full Information

NCT ID

NCT00964808

First Posted

August 24, 2009

Last Updated

December 5, 2014

Sponsor

Vejle Hospital

Collaborators

Norpharma A/S

1. Study Identification

Unique Protocol Identification Number

NCT00964808

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vejle Hospital

Collaborators

Norpharma A/S

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative

Keywords

Hip fractures, Treatment Outcome, Painkiller

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Buprenorphine

Arm Type

Experimental

Arm Description

Double dummy; Group A: Active Buprenorphine and placebo oxycodone

Arm Title

Oxycodone

Arm Type

Experimental

Arm Description

Double Dummy: Group B: Placebo Buprenorphine and Active Oxycodone

Intervention Type

Drug

Intervention Name(s)

Buprenorphine

Other Intervention Name(s)

Norspan

Intervention Description

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

Intervention Name(s)

Oxycodone

Other Intervention Name(s)

Oxycontin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mobilization measured daily using Cumulated Ambulation Score.

Time Frame

12 days

Secondary Outcome Measure Information:

Title

Pain intensity measured daily on a verbal rating scale

Time Frame

12 days

Title

Adverse effects

Time Frame

12 days + 14 days

Title

Opioid consumption.

Time Frame

12 days

Title

Length of stay in Hospital

Time Frame

Untill discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Per Kjaersgaard-Andersen, MD

Organizational Affiliation

Orthopaedic Department, Vejle Hospital, Denmark

Official's Role

Study Director

Facility Information:

Facility Name

Orthopaedic Department

City

Vejle

ZIP/Postal Code

7100

Country

Denmark

12. IPD Sharing Statement

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

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