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Postoperative Analgesia With Local Infiltration After Femoral Neck Fracture

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00529425
First Posted: September 14, 2007
Last Update Posted: May 6, 2010
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.
Information provided by:
Odense University Hospital
  Purpose
Reducing pain is an essential factor for early mobilization after osteosynthesis of femoral neck fractures. Systemic opioids have side effects that might obstruct mobilization and induce delirium and nausea. The investigators hypothesized that wound infiltration results in reduction in systemic opioid usage and pain relief without side effects.

Condition Intervention Phase
Femoral Neck Fracture Drug: Ropivacaine 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: Postoperative Analgesia With Local Infiltration After Femoral Neck Fracture vs. Traditional Treatment of Pain With Opioids

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Consumption of opioids

Secondary Outcome Measures:
  • Pain

Enrollment: 50
Study Start Date: January 2008
Study Completion Date: December 2008
Arms Assigned Interventions
Active Comparator: Ropivacaine Drug: Ropivacaine
Placebo Comparator: Saline Drug: Ropivacaine

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Femoral neck fracture
  • Fracture due to low energy trauma
  • Ability to understand danish and give informed consent
  • Ability to walk before trauma
  • Indication for osteosynthesis
  • ≥ 8 in OMC (Orientation-Memory-Concentration) test with a possible maximum of 28 points
  • Informed consent

Exclusion Criteria:

  • Drug or medical abuse
  • Drug intolerance
  • Pathological fractures
  • Inflammatory arthritis
  • Patient included in the study with the contralateral hip
  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): NCT00529425


Locations
Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Study Chair: Soren Overgaard, Professor, MD, DmSc Odense University Hospital, DK-5000 Odense C, Denmark
Principal Investigator: Rune Dueholm Bech, MD Odense University Hospital, DK-5000 Odense C, Denmark
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00529425     History of Changes
Other Study ID Numbers: S-VF-20060072 - femoral neck
First Submitted: September 12, 2007
First Posted: September 14, 2007
Last Update Posted: May 6, 2010
Last Verified: April 2010

Keywords provided by Odense University Hospital:
Femoral neck fracture
Hip fracture

Additional relevant MeSH terms:
Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents