Use of Local Analgesia With Epinephrine During Total Hip Arthroplasty (THA)
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|ClinicalTrials.gov Identifier: NCT00980616|
Recruitment Status : Completed
First Posted : September 21, 2009
Last Update Posted : March 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Arthroplasty, Replacement, Hip||Drug: ropivacaine, physical serum and adrenalin||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of the Injection of Local Analgesia With Epinephrine During Total Hip Arthroplasty on the Blood Losses Per and Operatively.|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||March 2012|
Experimental: Ropivacaine, serum, adrenalin
235 mg of ropivacaine, 5 ml physical serum and 0.5 mg of adrenalin.
Drug: ropivacaine, physical serum and adrenalin
A: experimental group: 235 mg of ropivacaine, 5 ml physical serum and 0.5 mg of adrenalin
No Intervention: No infiltration
B: no infiltration
- measuring volume of cumulated bleeding per and post operative and analyse of complete blood count (CBC) [ Time Frame: pre and post operative ]
- Womac score pre operative, at 3 months and at 12 months [ Time Frame: at 3 months and 12 months ]
- Visual analogue pain score (VAS) during hospitalisation [ Time Frame: at 3 months and 12 months ]
- Consumption of analgesics [ Time Frame: at 3 months and 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00980616
|CHU Clermont-Ferrand (orthopaedic surgery)|
|Clermont-Ferrand, France, 63003|
|Principal Investigator:||Stephane Descamps, MD||University Hospital, Clermont-Ferrand|