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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003730-10 | EudraCT Number |
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The patients will be included the 1. or 2. day after surgery. All THA patients will be screened. Those reporting VAS > 40 during active 30 degrees hip flexion will be asked to participate.
Included patients will receive 2xNCFL (singleshot) first placebo (8 ml saline) and then ropivacaine (8 ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be 45 minutes between the two blockades. The blockades will be ultrasound guided.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RP | Other | first blockade: ropivacaine 7,5mg/ml 8 ml second blockade: placebo: saline 8 ml |
|
| PR | Other | first blockade: placebo: saline 8 ml second blockade: ropivacaine 7,5mg/ml 8 ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Arm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml). Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in VAS between NCFL and placebo during active 30 degrees hip flexion | 45 min |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in mean VAS between the groups during active hip flexion | 15, 30, 45, 60, 75, 90 min | |
| Difference in mean VAS between the groups at rest | 15, 30, 45, 60, 75, 90 min |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Hägi-Pedersen, Ph.D. | Naestved Hospital, Department of Anaesthesiology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology | Næstved | Danmark | 4700 | Denmark |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Saline | Drug | Arm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml). Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml. |
|
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |