Postoperative Analgesia With Local Infiltration After Femoral Neck Fracture
Primary Purpose
Femoral Neck Fracture
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Ropivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fracture focused on measuring Femoral neck fracture, Hip fracture
Eligibility 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
Sites / Locations
- Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ropivacaine
Saline
Arm Description
Outcomes
Primary Outcome Measures
Consumption of opioids
Secondary Outcome Measures
Pain
Full Information
NCT ID
NCT00529425
First Posted
September 12, 2007
Last Updated
May 5, 2010
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00529425
Brief Title
Postoperative Analgesia With Local Infiltration After Femoral Neck Fracture
Official Title
Postoperative Analgesia With Local Infiltration After Femoral Neck Fracture vs. Traditional Treatment of Pain With Opioids
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Odense University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fracture
Keywords
Femoral neck fracture, Hip fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ropivacaine
Arm Type
Active Comparator
Arm Title
Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Primary Outcome Measure Information:
Title
Consumption of opioids
Secondary Outcome Measure Information:
Title
Pain
10. Eligibility
Sex
All
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soren Overgaard, Professor, MD, DmSc
Organizational Affiliation
Odense University Hospital, DK-5000 Odense C, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rune Dueholm Bech, MD
Organizational Affiliation
Odense University Hospital, DK-5000 Odense C, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
21484739
Citation
Bech RD, Lauritsen J, Ovesen O, Emmeluth C, Lindholm P, Overgaard S. Local anaesthetic wound infiltration after internal fixation of femoral neck fractures: a randomized, double-blind clinical trial in 33 patients. Hip Int. 2011 Mar-Apr;21(2):251-9. doi: 10.5301/HIP.2011.6513. Epub 2011 Apr 5.
Results Reference
derived
Learn more about this trial
Postoperative Analgesia With Local Infiltration After Femoral Neck Fracture
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