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

March 26, 2012 updated by: University Hospital, Clermont-Ferrand

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand (orthopaedic surgery)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary total hip arthroplasty
  • Age between 50 and 85

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
measuring volume of cumulated bleeding per and post operative and analyse of complete blood count (CBC)
Time Frame: pre and post operative
pre and post operative

Secondary Outcome Measures

Outcome Measure
Time Frame
Womac score pre operative, at 3 months and at 12 months
Time Frame: at 3 months and 12 months
at 3 months and 12 months
Visual analogue pain score (VAS) during hospitalisation
Time Frame: at 3 months and 12 months
at 3 months and 12 months
Consumption of analgesics
Time Frame: at 3 months and 12 months
at 3 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Stephane Descamps, MD, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

September 18, 2009

First Submitted That Met QC Criteria

September 18, 2009

First Posted (Estimate)

September 21, 2009

Study Record Updates

Last Update Posted (Estimate)

March 27, 2012

Last Update Submitted That Met QC Criteria

March 26, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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