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

Phase 2

Completed

• Conditions: Arthroplasty, Replacement, Hip
• Interventions: Drug: ropivacaine, physical serum and adrenalin

• Registration Number: NCT00980616
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-18
• Study First Submitted QC: 2009-09-18
• Study First Posted: 2009-09-21
• Primary Completion: 2010-09
• Status Verified: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-26
• Last Update Posted: 2012-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine, serum, adrenalin	ropivacaine, physical serum and adrenalin	235 mg of ropivacaine, 5 ml physical serum and 0.5 mg of adrenalin.

Primary Outcome Measures

Name	Time	Method
measuring volume of cumulated bleeding per and post operative and analyse of complete blood count (CBC)	pre and post operative

Secondary Outcome Measures

Name	Time	Method
Womac score pre operative, at 3 months and at 12 months	at 3 months and 12 months
Visual analogue pain score (VAS) during hospitalisation	at 3 months and 12 months
Consumption of analgesics	at 3 months and 12 months

Trial Locations

Locations (1)

CHU Clermont-Ferrand (orthopaedic surgery); 🇫🇷 Clermont-Ferrand, France