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

NCT ID: NCT00980616

Last Updated: 2012-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Arthroplasty, Replacement, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ropivacaine, serum, adrenalin

235 mg of ropivacaine, 5 ml physical serum and 0.5 mg of adrenalin.

Group Type EXPERIMENTAL

ropivacaine, physical serum and adrenalin

Intervention Type DRUG

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

No infiltration

B: no infiltration

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ropivacaine, physical serum and adrenalin

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Primary total hip arthroplasty
* Age between 50 and 85

Exclusion Criteria

* fracture of the femoral neck
* patients with contraindications for local anaesthesia
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephane Descamps, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand (orthopaedic surgery)

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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CHU-0056

Identifier Type: -

Identifier Source: org_study_id

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