NCT00603083

Brief Summary

The purpose of this study is to determine whether the investigator standardized pain treatment plus local pain treatment is more effective than the investigator standardized pain treatment plus placebo in total hip arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

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

January 1, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

December 9, 2011

Status Verified

December 1, 2011

Enrollment Period

9 months

First QC Date

January 2, 2008

Last Update Submit

December 8, 2011

Conditions

Pain, Postoperative

Keywords

Hip ArthroplastyTreatment OutcomeLocal Anesthesia

Outcome Measures

Primary Outcomes (2)

  • Pain score

    24 hours

  • Opioid Consumption

    24 hours

Secondary Outcomes (5)

  • Pain score

    7 days

  • Opioid consumption

    3 days

  • Postoperative Nausea and Vomiting (PONV)

    3 days

  • Fatigue

    3 days

  • Physical function

    2 month

Study Arms (2)

A

ACTIVE COMPARATOR

This group receive local analgesic with Ropivacaine 200 mg, Ketorolac 30 mg and Adrenaline 1 mg 10 and 22 hours after the operation. The medicine solution is given in a catheter, wich is placed in the hip at the end of the operation.

Drug: Ropivacaine, Ketorolac and Adrenalin

B

PLACEBO COMPARATOR

This group receive Placebo 10 and 22 hours after the operation. The Placebo is given in a catheter, wich is placed in the hip at the end of the operation.

Drug: Placebo

Interventions

Ropivacaine, Ketorolac and AdrenalinDRUG

The local analgesic with Ropivacaine 200 mg, Ketorolac 30 mg and Adrenaline 1 mg is given 10 and 22 hours after the operation. The medicine solution is administrated in a catheter, which is placed in the hip at the end of the operation.

Also known as: Naropin, Toradol
A
PlaceboDRUG

This group receive Placebo 10 and 22 hours after the operation. The Placebo is given in a catheter, which is placed in the hip at the end of the operation.

Also known as: Saline
B

Eligibility Criteria

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

You may qualify if:

  • Scheduled for an uncemented unilateral Total Hip Replacement because of osteoarthritis
  • Willingness and possibility to follow the instructions of the study
  • years or older
  • written informed consent and authority after it has been read and understood.

You may not qualify if:

  • Operation with anterior approach or using navigation
  • Do not understand or speech danish
  • Can not use the pain-score Numerical Rating Scale (NRS)
  • Special indications for Total Hip Replacement
  • Anaesthetized in general anaesthesia where a tube is demanded
  • Daily use of strong opioids, based on the investigators assessment
  • Fertile women
  • ASA-score: 3 and 4
  • Known allergy against the standardized pain treatment, the study drugs and placebo, Ropivacaine, Ketorolac, Adrenalin.
  • Treatment with Lithium, Dihydroergotamin, full anticoagulant treatment or MAO-inhibitor
  • Following illness:
  • Active gastric ulcer or earlier gastrointestinal bleeding, ulceration or perforation of any kind.
  • Suspicions of manifest gastrointestinal bleeding and/or cerebrovascular bleeding
  • Haemorrhagic diathesis
  • Coagulation disorder
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Orthopaedic Department

Vejle, 7100, Denmark

Location

Ortopaedic Department, Vejle Hospital

Vejle, 7100, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

RopivacaineKetorolacEpinephrineKetorolac TromethamineSodium Chloride

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, CyclicHydrocarbonsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Per Kjaersgaard-Andersen, MD

    Ortopaedic Department, Vejle Hospital, Denmark

    PRINCIPAL INVESTIGATOR

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
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Per Kjaersgaard-Andersen MD

Study Record Dates

First Submitted

January 2, 2008

First Posted

January 28, 2008

Study Start

January 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

December 9, 2011

Record last verified: 2011-12

Locations

DK(2)