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

U

University Hospital, Clermont-Ferrand

Status and phase

Completed
Phase 2

Conditions

Arthroplasty, Replacement, Hip

Treatments

Drug: ropivacaine, physical serum and adrenalin

Study type

Interventional

Funder types

Other

Identifiers

NCT00980616
CHU-0056

Details and patient eligibility

About

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.

Full 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).

Enrollment

150 patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Primary total hip arthroplasty
  • Age between 50 and 85

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

150 participants in 2 patient groups

Ropivacaine, serum, adrenalin
Experimental group
Description:
235 mg of ropivacaine, 5 ml physical serum and 0.5 mg of adrenalin.
Treatment:
Drug: ropivacaine, physical serum and adrenalin
No infiltration
No Intervention group
Description:
B: no infiltration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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