Clinical trial NCT00603083: Postoperative Pain Treatment in Total Hip Arthroplasty: A Study to Assess the Effect of Local Analgesia
Official title: Postoperative Pain Treatment in Total Hip Arthroplasty A Randomized Double-blinded Placebo-controlled Study to Assess the Effect of Local Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: Hip Arthroplasty
Treatment Outcome
Local Anesthesia
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2008-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain score
timeFrame: 24 hours
measure: Opioid Consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Pain score
timeFrame: 7 days
measure: Opioid consumption
timeFrame: 3 days
measure: Postoperative Nausea and Vomiting (PONV)
timeFrame: 3 days
measure: Fatigue
timeFrame: 3 days
measure: Physical function
timeFrame: 2 month
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Orthopaedic Department
city: Vejle
country: Denmark
facility: Ortopaedic Department, Vejle Hospital
Study officials:
affiliation: Ortopaedic Department, Vejle Hospital, Denmark
name: Per Kjaersgaard-Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References: