Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-41-3785 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lundbeck Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to compare the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain intensity after total hip arthroplasty.
The hypothesis is that local infiltration analgesia reduces the acute postoperative pain intensity.
In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total hip arthroplasty is still associated with postoperative pain and delayed rehabilitation. We therefore decided to evaluate the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain intensity in a well defined, multimodal, fast-track setup after hip arthroplasty. The technique is widely used as standard treatment in many European centers despite its limited evidence.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local infiltration with ropivacaine | Active Comparator | Local infiltration with ropivacaine 0,2% (150 ML) |
|
| Local infiltration with saline | Placebo Comparator | Local infiltration with saline (150 ML) (placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Local infiltration with ropivacaine 0,2% (150 ML) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain scores on the Visual Analog Scale (during walking) | up to 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Additional analgetics measured as cumulated amount i mg | up to 8 hours | |
| Time spend in hospital measured as nights after surgery | At discharge (mean 2-3 nights) | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre University Hospital | Copenhagen | Hvidover | 2650 | Denmark | ||
| Hørsholm Hospital |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |
| up to 8 hours |
| Postoperative pain scores on the Visual Analog Scale (at rest) | up to 8 hour |
| Hørsholm |
| Hørsholm |
| 2970 |
| Denmark |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |