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Completed

NCT Number: NCT00603083

Postoperative Pain Treatment in Total Hip Arthroplasty: A 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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Orthopaedic Department, Vejle, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine, Ketorolac and Adrenalin

Drug

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.

Other names: Naropin, Toradol

Placebo

Drug

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.

Other names: Saline

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

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 28, 2008
Registry last updated
Dec 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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