NCT00964808

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

3.7 years

First QC Date

August 24, 2009

Last Update Submit

December 5, 2014

Conditions

Pain, Postoperative

Keywords

Hip fracturesTreatment OutcomePainkiller

Outcome Measures

Primary Outcomes (1)

  • Mobilization measured daily using Cumulated Ambulation Score.

    12 days

Secondary Outcomes (4)

  • 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

Study Arms (2)

Buprenorphine

EXPERIMENTAL

Double dummy; Group A: Active Buprenorphine and placebo oxycodone

Drug: Buprenorphine

Oxycodone

EXPERIMENTAL

Double Dummy: Group B: Placebo Buprenorphine and Active Oxycodone

Drug: Oxycodone

Interventions

BuprenorphineDRUG

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

Also known as: Norspan
Buprenorphine
OxycodoneDRUG

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.

Also known as: Oxycontin
Oxycodone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Department

Vejle, 7100, Denmark

Location

MeSH Terms

Conditions

Pain, PostoperativeHip Fractures

Interventions

BuprenorphineOxycodone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsCodeineMorphine Derivatives

Study Officials

  • Per Kjaersgaard-Andersen, MD

    Orthopaedic Department, Vejle Hospital, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 25, 2009

Study Start

September 1, 2009

Primary Completion

May 1, 2013

Study Completion

August 1, 2013

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations

DK(1)