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CompletedNCT00603083Updated Dec 9, 2011

Postoperative Pain Treatment in Total Hip Arthroplasty: A Study to Assess the Effect of Local Analgesia

A Phase 4 interventional study of Ropivacaine, Ketorolac and Adrenalin and Placebo in Pain, Postoperative, sponsored by Vejle Hospital. Completed at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-12-09.

Sponsored by Vejle Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pain, Postoperative

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Keywords

  • Hip Arthroplasty
  • Treatment Outcome
  • Local Anesthesia
03

In context

Pain, Postoperative

5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.

This study's enrollment of 60 is below the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Vejle Hospital is the lead sponsor of 95 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Severe thrombocytopenia
  • Severe heart insufficiency
  • Severe risk of postoperative bleeding or delayed haemostatic
  • Myocardium hypertrophy or ischaemic heart disease
  • Hypertension
  • Hypovolemics
  • Anhydration
  • angiooedema
  • Asthma
  • Bronchospasm
  • Severe liver insufficiency
  • Rhinostenosis because of polyostotic
  • Narrow-angled glaucoma
  • Phaeochromocytoma
  • Low plasm-potassium
  • Thyreotoxicosis
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    A

    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

  • Placebo comparator
    B

    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

  • DrugRopivacaine, Ketorolac and Adrenalin

    Drug pages: Ropivacaine · Ketorolac · Epinephrine

    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

  • DrugPlacebo

    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

06

What researchers measure

Primary outcomes

  1. Pain score

    Time frame: 24 hours

  2. Opioid Consumption

    Time frame: 24 hours

Secondary outcomes

  1. Pain score

    Time frame: 7 days

  2. Opioid consumption

    Time frame: 3 days

  3. Postoperative Nausea and Vomiting (PONV)

    Time frame: 3 days

  4. Fatigue

    Time frame: 3 days

  5. Physical function

    Time frame: 2 month

07

Study locations

2 sites
  • Orthopaedic Department
    Vejle, 7100, Denmark
  • Ortopaedic Department, Vejle Hospital
    Vejle, 7100, Denmark
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2008, a primary completion of Oct 2008 and a completion of Oct 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 2, 2008
First posted
Jan 28, 2008
Start
Jan 2008
Primary completionActual
Oct 2008
CompletionActual
Oct 2008
Last update
Dec 9, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 9, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00603083
Lead sponsor
Vejle Hospital
Responsible party
Per Kjaersgaard-Andersen (Per Kjaersgaard-Andersen MD, Vejle Hospital) — Principal investigator
First posted
Jan 28, 2008
Start date
Jan 2008
Primary completion
Oct 2008
Completion
Oct 2008
Last update
Dec 9, 2011

Study contacts

Per Kjaersgaard-Andersen, MD
principal investigator · Ortopaedic Department, Vejle Hospital, Denmark

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Ropivacaine · Ketorolac · Epinephrine

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