Hip Fracture of Intertrochanteric Type Clinical Trial
Official title:
Postoperative Analgesia With Local Infiltration After Hip Fracture Of Intertrochanteric Type
| Verified date | March 2011 |
| Source | Odense University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: Danish Medicines Agency |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 74 |
| Est. completion date | January 2011 |
| Est. primary completion date | January 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Drug or medical abuse - Drug intolerance - Pathological fractures - Inflammatory arthritis - Patient included in the study with the contralateral hip |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Odense University Hospital | Odense | DK |
| Lead Sponsor | Collaborator |
|---|---|
| Odense University Hospital |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Consumption of opioids | 5 days postoperatively | No | |
| Secondary | Pain | 5 days postoperatively | No |