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Postoperative Analgesia With Local Infiltration After Femoral Neck Fracture

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00529425
First received: September 12, 2007
Last updated: May 5, 2010
Last verified: April 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Fractures
U.S. FDA Resources

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00529425     History of Changes
Other Study ID Numbers: S-VF-20060072 - femoral neck
Study First Received: September 12, 2007
Last Updated: May 5, 2010
Health Authority: Denmark: Danish Medicines Agency

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

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

ClinicalTrials.gov processed this record on May 23, 2013