NCT00421967

Brief Summary

Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain. Although epidural treatment provides good and reliable postoperative pain relief after THA, it may cause urinary retention, nausea, hypotension, diminished muscle control, and delayed mobilization. The challenge of new analgesic regimes is to reduce the occurrence of side effects while maintaining adequate pain relief and maximum muscle control. A relatively new method to provide postoperative pain relief after TKA is local infiltration analgesia combined with single-shot injection(s) or continuous infusion of local anesthetics into the surgical site. As local infiltration analgesia combined with continuous intraarticular infusion compared with continuous epidural infusion has not been evaluated, our study was designed to determine whether this technique could enhance analgesia and improve patient outcome after TKA. This study compares continuous epidural infusion of Ropivacaine and intravenous Ketorolac with local infiltration analgesia with Ropivacaine, Ketorolac and Adrenaline combined with continuous intraarticular infusion of Ropivacaine and Ketorolac.

Trial Health

57
Monitor

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 Jan 2007

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2007

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

May 7, 2008

Status Verified

May 1, 2008

Enrollment Period

1.2 years

First QC Date

January 12, 2007

Last Update Submit

May 6, 2008

Conditions

Arthroplasty, Replacement, Knee

Keywords

Postoperative pain

Outcome Measures

Primary Outcomes (1)

  • AnalgĂ©sia consumption

    48 h

Secondary Outcomes (4)

  • Time to discharge

  • Cytokine level

    48 h

  • Pain scores VAS

    72 h

  • Side-effects

    72 h

Study Arms (2)

1

EXPERIMENTAL
Drug: Ropivacaine, Ketorolac, adrenaline

2

ACTIVE COMPARATOR
Drug: Ropivacaine Ketorolac

Interventions

Ropivacaine, Ketorolac, adrenalineDRUG

Infiltration: 150 ml Ropivacaine 2mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml Adrenaline 1 mg/ml Intraarticular infusion: 4 ml/h 384 mg Ropivacaine 60 mg Ketorolac

1
Ropivacaine KetorolacDRUG

Epidural infusion: 4 ml/h 384 mg Ropivacaine I.V. Ketorolac 90 mg

2

Eligibility Criteria

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

You may qualify if:

  • Patients admitted consecutively to primary total knee arthroplasty.
  • Provided informed consent

You may not qualify if:

  • Fertile women with positive pregnancy test, nursing mothers, fertile women who do not use safe contraception
  • Severe chronic neurogenic pain
  • Medical treated diabetes
  • Contraindications for spinal aesthesia and epidural analgesia
  • Known hypersensitivity towards study drugs
  • Rheumatoid arthritis
  • Treatment with narcotics
  • Treatment with antidepressants
  • Severe obesity BMI\>35
  • Treatment with antacid
  • Not able to speak and understand Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glostrup Hospital

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

RopivacaineKetorolacEpinephrine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Birgitte V Christensen, M.D.

    Glostrup Hospital, Glostrup 2600, 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

January 12, 2007

First Posted

January 15, 2007

Study Start

January 1, 2007

Primary Completion

March 1, 2008

Study Completion

April 1, 2008

Last Updated

May 7, 2008

Record last verified: 2008-05

Locations

DK(1)