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Completed

NCT Number: NCT00980616

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

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.

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Key information

Conditions

Arthroplasty, Replacement, Hip Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Clermont-Ferrand (orthopaedic surgery)

Clermont-Ferrand, 63003, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary total hip arthroplasty
  • Age between 50 and 85

Exclusion criteria

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

Treatment and study plan

ropivacaine, physical serum and adrenalin

Drug

A: experimental group: 235 mg of ropivacaine, 5 ml physical serum and 0.5 mg of adrenalin

Primary outcomes

  1. measuring volume of cumulated bleeding per and post operative and analyse of complete blood count (CBC)

    Time frame: pre and post operative

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Effect of the Injection of Local Analgesia With Epinephrine During Total Hip Arthroplasty on the Blood Losses Per and Operatively.

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Sep 21, 2009
Registry last updated
Mar 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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