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

Verified by: Vejle Hospital, December 2011
First Received: January 2, 2008 | Last Updated: December 8, 2011 | Phase: Phase 4 | Start Date: January 2008
Overall Status: Completed | Estimated Enrollment: 60
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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...

Brief Summary

Official Title: “Postoperative Pain Treatment in Total Hip Arthroplasty A Randomized Double-blinded Placebo-controlled Study to Assess the Effect of Local Analgesia”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

  • Drug: Ropivacaine, Ketorolac and Adrenalin
    • 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.
  • Drug: Placebo
    • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • 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.
  • 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.

Outcome Measures for this Clinical Trial

Primary Measures

  • Pain score
    • Time Frame: 24 hours
      Safety Issue?: No
  • Opioid Consumption
    • Time Frame: 24 hours
      Safety Issue?: No

Secondary Measures

  • Pain score
    • Time Frame: 7 days
      Safety Issue?: No
  • Opioid consumption
    • Time Frame: 3 days
      Safety Issue?: No
  • Postoperative Nausea and Vomiting (PONV)
    • Time Frame: 3 days
      Safety Issue?: No
  • Fatigue
    • Time Frame: 3 days
      Safety Issue?: No
  • Physical function
    • Time Frame: 2 month
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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:

  • 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Vejle Hospital Other

Overall Clinical Trial Officials and Contacts

Per Kjaersgaard-Andersen, MD Principal Investigator Ortopaedic Department, Vejle Hospital, Denmark  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00603083

Study ID Number: EudraCT number 2007-003890-20

ClinicalTrials.gov Identifier: NCT00603083

Health Authority: Denmark: Danish Medicines Agency

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00603083