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The aim is to determine if the use of infiltration with an adrenalin solution in the operative field of Total Hip Arthroplasty (THA), allays a significant reduction of the cumulated volume of bleeding (pre and post operative) without increasing the per and post operative risks. At the same time, the effect on the post operational pains is evaluated.
This prospective randomized study compares a population receiving a local anaesthetic (ropivacaine, adrenalin and physiological serum) in the operative field to a population undergoing a standard protocol.
The cumulated volume of bleeding per and post operative are recorded and complete blood count (CBC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine, serum, adrenalin | Experimental | 235 mg of ropivacaine, 5 ml physical serum and 0.5 mg of adrenalin. |
|
| No infiltration | No Intervention | B: no infiltration |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ropivacaine, physical serum and adrenalin | Drug | A: experimental group: 235 mg of ropivacaine, 5 ml physical serum and 0.5 mg of adrenalin |
|
| Measure | Description | Time Frame |
|---|---|---|
| measuring volume of cumulated bleeding per and post operative and analyse of complete blood count (CBC) | pre and post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Womac score pre operative, at 3 months and at 12 months | at 3 months and 12 months | |
| Visual analogue pain score (VAS) during hospitalisation | at 3 months and 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephane Descamps, MD | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand (orthopaedic surgery) | Clermont-Ferrand | 63003 | France |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Consumption of analgesics |
| at 3 months and 12 months |
| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |