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

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00980616
• Other study ID #: CHU-0056
• Status: Completed
• Phase: Phase 2
• First received: September 18, 2009
• Last updated: March 26, 2012
• Start date: September 2009
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2012
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand (orthopaedic surgery)	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measuring volume of cumulated bleeding per and post operative and analyse of complete blood count (CBC)		pre and post operative	Yes
Secondary	Womac score pre operative, at 3 months and at 12 months		at 3 months and 12 months	Yes
Secondary	Visual analogue pain score (VAS) during hospitalisation		at 3 months and 12 months	Yes
Secondary	Consumption of analgesics		at 3 months and 12 months	Yes