NCT00562627

Brief Summary

Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge. The aim of this study is to:

  1. 1.Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
  2. 2.Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2007

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

November 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 22, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

August 8, 2011

Completed
Last Updated

August 8, 2011

Status Verified

August 1, 2011

Enrollment Period

1.6 years

First QC Date

November 21, 2007

Results QC Date

May 24, 2011

Last Update Submit

August 5, 2011

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritisknee arthroplastylocal infiltration analgesiaTKAepidural analgesiaoperationsurgery

Outcome Measures

Primary Outcomes (1)

  • Pain at Rest (VAS)

    VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain.

    48 hours postoperative

Secondary Outcomes (2)

  • Opioid Use

    48 hours postoperative

  • Time to Readiness for Discharge

    up to 10 days postoperative

Study Arms (3)

LIA IV

EXPERIMENTAL

Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine

Drug: ropivacaineDrug: adrenalineDrug: ketorolacDrug: morphine

LIA IA

EXPERIMENTAL

Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine

Drug: ropivacaineDrug: adrenalineDrug: ketorolacDrug: morphine

EDA

ACTIVE COMPARATOR

standard continuous epidural analgesia

Drug: adrenalineDrug: fentanylDrug: bupivacaine

Interventions

ropivacaineDRUG

intraoperative and 1. postoperative day

Also known as: Naropin
LIA IALIA IV
adrenalineDRUG

intraoperative LIA (IV and IA) and continuous EDA

Also known as: Adrenalin, (epinephrine)
EDALIA IALIA IV
ketorolacDRUG

intraoperative and 1. postoperative day

Also known as: Toradol
LIA IALIA IV
morphineDRUG

intraoperative

Also known as: Morfin
LIA IALIA IV
fentanylDRUG

continuous postoperatively

EDA
bupivacaineDRUG

continuous postoperatively

Also known as: Marcain
EDA

Eligibility Criteria

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

You may qualify if:

  • patients at least 18 years of age
  • scheduled for elective total knee arthroplasty
  • ASA I-III
  • signed written informed consent

You may not qualify if:

  • age \< 18
  • ASA \> III
  • moderate or severe cardiac disease, bronchial asthma
  • allergy against ropivacaine, ketorolac or morphine
  • analgetic abuse
  • pregnancy or nursing women
  • severe psychiatric disease
  • moderate to severe dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asker and Baerum Hospital

Rud, 1309, Norway

Location

Related Publications (1)

  • Spreng UJ, Dahl V, Hjall A, Fagerland MW, Raeder J. High-volume local infiltration analgesia combined with intravenous or local ketorolac+morphine compared with epidural analgesia after total knee arthroplasty. Br J Anaesth. 2010 Nov;105(5):675-82. doi: 10.1093/bja/aeq232. Epub 2010 Aug 24.

    PMID: 20736233DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

RopivacaineEpinephrineKetorolacKetorolac TromethamineMorphineFentanylBupivacaine

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Ulrich Johannes Spreng
Organization
Baerum Hospital
ulispreng@hotmail.com
004798499184

Study Officials

  • Ulrich J Spreng, MD

    Asker and Baerum Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 22, 2007

Study Start

November 1, 2007

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

August 8, 2011

Results First Posted

August 8, 2011

Record last verified: 2011-08

Locations

NO(1)