NCT00980616

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 27, 2012

Status Verified

March 1, 2012

Enrollment Period

1 year

First QC Date

September 18, 2009

Last Update Submit

March 26, 2012

Conditions

Arthroplasty, Replacement, Hip

Keywords

Arthroplasty, hipblood lossespainlocal analgesiaepinephrinePrimary total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

  • measuring volume of cumulated bleeding per and post operative and analyse of complete blood count (CBC)

    pre and post operative

Secondary Outcomes (3)

  • 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

Study Arms (2)

Ropivacaine, serum, adrenalin

EXPERIMENTAL

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

Drug: ropivacaine, physical serum and adrenalin

No infiltration

NO INTERVENTION

B: no infiltration

Interventions

ropivacaine, physical serum and adrenalinDRUG

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

Ropivacaine, serum, adrenalin

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary total hip arthroplasty
  • Age between 50 and 85

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand (orthopaedic surgery)

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Pain

Interventions

RopivacaineEpinephrine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Stephane Descamps, MD

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2009

First Posted

September 21, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2010

Study Completion

March 1, 2012

Last Updated

March 27, 2012

Record last verified: 2012-03

Locations

FR(1)