Postoperative Analgesia With Local Infiltration After Hip Fracture Of Intertrochanteric Type
1 other identifier
interventional
74
1 country
1
Brief Summary
Reducing pain is an essential factor for early mobilization after osteosynthesis of intertrochanteric 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 4, 2010
CompletedFirst Posted
Study publicly available on registry
May 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedMarch 16, 2011
March 1, 2011
2.9 years
May 4, 2010
March 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Consumption of opioids
5 days postoperatively
Secondary Outcomes (1)
Pain
5 days postoperatively
Study Arms (2)
Ropivacaine
ACTIVE COMPARATORSaline
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Intertrochanteric hip 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
You may not qualify if:
- Drug or medical abuse
- Drug intolerance
- Pathological fractures
- Inflammatory arthritis
- Patient included in the study with the contralateral hip
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Odense University Hospital
Odense, DK, 5000, Denmark
Related Publications (1)
Bech RD, Ovesen O, Lauritsen J, Emmeluth C, Lindholm P, Overgaard S. Local Anesthetic Wound Infiltration after Osteosynthesis of Extracapsular Hip Fracture Does Not Reduce Pain or Opioid Requirements: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial in 49 Patients. Pain Res Manag. 2018 Nov 13;2018:6398424. doi: 10.1155/2018/6398424. eCollection 2018.
PMID: 30538796DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Soren Overgaard, MD, DmSc
Odense University Hospital, DK-5000 Odense C, Denmark
- PRINCIPAL INVESTIGATOR
Rune Dueholm Bech, MD
Odense University Hospital, DK-5000 Odense C, Denmark
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
Study Record Dates
First Submitted
May 4, 2010
First Posted
May 7, 2010
Study Start
February 1, 2008
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
March 16, 2011
Record last verified: 2011-03