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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Hip Drug: ropivacaine, physical serum and adrenalin Phase 2

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. measuring volume of cumulated bleeding per and post operative and analyse of complete blood count (CBC) [ Time Frame: pre and post operative ]

Secondary Outcome Measures :
  1. Womac score pre operative, at 3 months and at 12 months [ Time Frame: at 3 months and 12 months ]
  2. Visual analogue pain score (VAS) during hospitalisation [ Time Frame: at 3 months and 12 months ]
  3. Consumption of analgesics [ Time Frame: at 3 months and 12 months ]


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary total hip arthroplasty
  • Age between 50 and 85

Exclusion Criteria:

  • fracture of the femoral neck
  • patients with contraindications for local anaesthesia

Information from the National Library of Medicine

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


Locations
France
CHU Clermont-Ferrand (orthopaedic surgery)
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Stephane Descamps, MD University Hospital, Clermont-Ferrand

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00980616     History of Changes
Other Study ID Numbers: CHU-0056
First Posted: September 21, 2009    Key Record Dates
Last Update Posted: March 27, 2012
Last Verified: March 2012

Keywords provided by University Hospital, Clermont-Ferrand:
Arthroplasty, hip
blood losses
pain
local analgesia
epinephrine
Primary total hip arthroplasty

Additional relevant MeSH terms:
Ropivacaine
Epinephrine
Racepinephrine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents