Postoperative Pain Treatment in Total Hip Arthroplasty: A Study to Assess the Effect of Local Analgesia
NCT ID: NCT00603083
Last Updated: 2011-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2008-01-31
2008-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vejle Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Per Kjaersgaard-Andersen
Per Kjaersgaard-Andersen MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Per Kjaersgaard-Andersen, MD
Role: PRINCIPAL_INVESTIGATOR
Ortopaedic Department, Vejle Hospital, Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Orthopaedic Department
Vejle, , Denmark
Ortopaedic Department, Vejle Hospital
Vejle, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S-20070066
Identifier Type: -
Identifier Source: secondary_id
EudraCT number 2007-003890-20
Identifier Type: -
Identifier Source: org_study_id