Use of Local Analgesia With Epinephrine During Total Hip Arthroplasty (THA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00980616
First received: September 18, 2009
Last updated: March 26, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Arthroplasty, Replacement, Hip
Drug: ropivacaine, physical serum and adrenalin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • measuring volume of cumulated bleeding per and post operative and analyse of complete blood count (CBC) [ Time Frame: pre and post operative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Womac score pre operative, at 3 months and at 12 months [ Time Frame: at 3 months and 12 months ] [ Designated as safety issue: Yes ]
  • Visual analogue pain score (VAS) during hospitalisation [ Time Frame: at 3 months and 12 months ] [ Designated as safety issue: Yes ]
  • Consumption of analgesics [ Time Frame: at 3 months and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: September 2009
Study Completion Date: March 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00980616     History of Changes
Other Study ID Numbers: CHU-0056
Study First Received: September 18, 2009
Last Updated: March 26, 2012
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 23, 2014