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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021918-30 | EudraCT Number |
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The objective of this study is to assess the efficacy of Adductor-Canal-Blockade on pain and morphine consumption after total knee arthroplasty. Our hypothesis is that the Adductor -Canal-Blockade is superior to placebo in reducing pain and morphine consumption after total knee arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adductor-Canal-Blockade with Ropivacaine | Active Comparator |
| |
| Adductor-Canal-blockade with saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adductor-Canal-Blockade with Ropivacaine | Procedure | US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain during 45 degrees active flexion of the knee | 0-100 mm at a visual analogue scale (VAS), at 1 hour postoperative | 1 hour postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Pain during 45 degrees active flexion of the knee | 0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-6 hours postoperative. | 0-6 hours postoperative |
| Pain during rest |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pia Jæger, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital | Gentofte Municipality | Hellerup | 2900 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22834681 | Derived | Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012 Sep;56(8):1013-9. doi: 10.1111/j.1399-6576.2012.02737.x. Epub 2012 Jul 26. |
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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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| Adductor-Canal-blockade with saline | Procedure | US-guided Adductor-Canal-blockade with saline |
|
|
0-100 mm at a visual analogue scale (VAS), registered at the intervals 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as "the area under the curve" (AUC) for the interval 1-6 hours postoperative. |
| 1-6 hours postoperative |
| A change in pain score in the ropivacaine group, after activating the block | 0-100 mm at a visual analogue scale (VAS), at 30 and 60 minutes postoperative. A change in pain score in the ropivacaine group compared to the placebo group, after activating the block. | 30-60 minutes postoperative |
| Total morphine consumption | Total morphine consumption at the interval 30 minutes - 6 hours postoperative. | 30 minutes - 6 hours postoperative |
| Postoperative nausea | Nausea scores(0-3)registered at 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as mean value for the interval 1-6 hours postoperative. | 1-6 hours postoperative |
| Postoperative vomiting | Number of vomiting episodes at the interval 1-6 hours postoperative. | 1-6 hours postoperative |
| Zofran consumption | Total zofran consumption at the intervals 1-6 hours postoperative. | 1-6 hours postoperative |
| Sedation | Sedation score (0-3) registered at 1, 2, 3, 4, 5 and 6 hours postoperative, calculated as the mean value for the interval 1-6 hours postoperative. | 1-6 hours postoperative |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |