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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Ropivacaine, Ketorolac and Adrenalin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>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<br>* 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.<br>* Other names: Toradol;|
| Placebo Comparator: B<br>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<br>* 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.<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score |  | 24 hours | 
| Opioid Consumption |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score |  | 7 days | 
| Opioid consumption |  | 3 days | 
| Postoperative Nausea and Vomiting (PONV) |  | 3 days | 
| Fatigue |  | 3 days | 
| Physical function |  | 2 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip Arthroplasty, Treatment Outcome, Local Anesthesia