NCT00289419

Brief Summary

The purpose of this study is to determine whether wound infiltration with following single-shot bolus injection with local anesthetic and NASIDs are effective in the treatment of postoperative pain after total hip replacement compared to continuous epidural infusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2006

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

May 7, 2008

Status Verified

May 1, 2008

Enrollment Period

1 year

First QC Date

February 8, 2006

Last Update Submit

May 6, 2008

Conditions

Arthroplasty, Replacement, Hip

Keywords

Arthroplasty, Replacement, HipAnesthetics, LocalPain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Consumption af analgesics

    96 h

Secondary Outcomes (3)

  • Side effects

    96 h

  • Mobilization level

    8 h

  • Pain scores VAS

    96 h

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: Epidural Ropivacaine, morphine

B

EXPERIMENTAL
Drug: Ropivacaine, Ketorolac and Adrenaline

Interventions

Epidural Ropivacaine, morphineDRUG

Infusion rate 4 ml/h in 48 h Solution 200 ml Ropivacaine 2mg/ml added 1 ml morphine 10 mg/ml

A
Ropivacaine, Ketorolac and AdrenalineDRUG

Wound infiltration: 100 ml Ropivacaine 2 mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml adrenaline 1 mg/ml Bolus injection: 20 ml Ropivacaine 7,5mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml adrenaline 1 mg/ml

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted consecutively to primary total hip arthroplasty due to arthrosis

You may not qualify if:

  • Patients unable to provide informed consent
  • Patients with contraindications for spinal anesthesia
  • Patients with known hypersensitivity towards the used drugs
  • Patients with severe chronic neurogenic pain
  • Patients with Rheumatoid arthritis
  • Patients with a daily opioid consumption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopedic Center, Aarhus University Hospital

Aarhus, Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

MorphineRopivacaineKetorolacEpinephrine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesIndomethacinIndolesHeterocyclic Compounds, 2-RingEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Kjeld Søballe, Professor

    Orthopedic Center, Aarhus University Hospital, Aarhus, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 8, 2006

First Posted

February 9, 2006

Study Start

February 1, 2005

Primary Completion

February 1, 2006

Study Completion

March 1, 2006

Last Updated

May 7, 2008

Record last verified: 2008-05

Locations

DK(1)