Intraarticular Analgesia After Total Hip Arthroplasty, a Randomised Study

Study Overview
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Brief Summary
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The purpose of this study is to determine whether wound infiltration with following single-shot bolus injection with local anesthetic and NASIDs are effective in the treatment of postoperative pain after total hip replacement compared to continuous epidural infusion.

Detailed Description
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Sufficient postoperative pain relief after total hip replacement is necessary to achieve normal mobilisation and a reduction of the surgical stress response. After total hip replacement epidural treatment has proven superior, with regards to pain relief, than treatment with parenteral infusions and periphery nerve blocks. Even though epidural treatment gives excellent pain relief adverse effect as motor block, urine retention, hypotension and itching occurs regularly which delays rehabilitation. Treatment with the administration of local anesthetic in the operating field has shown its efficiency in reducing postoperative pain with a low incidence of adverse effects after various surgical procedures. This study compares continuous epidural infusion of ropivacaine added morphine to a new technique, where ropivacaine, ketorolac and adrenaline is used to infiltrate the tissue around the hip joint during surgery, and is injected by an intraarticular catheter 8 hours postoperative. Data of pain scores, analgesia consumption, adverse effects and mobilisation is collected for the first 4 postoperative days.

Official Title
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Postoperative Analgesia After Total Hip Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Intraarticular Bolus Injection.

Conditions
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Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Drug: Epidural Ropivacaine, morphine
* Drug: Ropivacaine, Ketorolac and Adrenaline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted consecutively to primary total hip arthroplasty due to arthrosis Exclusion Criteria: Patients unable to provide informed consent Patients with contraindications for spinal anesthesia Patients with known hypersensitivity towards the used drugs Patients with severe chronic neurogenic pain Patients with Rheumatoid arthritis Patients with a daily opioid consumption

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Epidural Ropivacaine, morphine<br>* Infusion rate 4 ml/h in 48 h Solution 200 ml Ropivacaine 2mg/ml added 1 ml morphine 10 mg/ml<br>|
| Experimental: B<br> | Drug: Ropivacaine, Ketorolac and Adrenaline<br>* Wound infiltration: 100 ml Ropivacaine 2 mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml adrenaline 1 mg/ml Bolus injection: 20 ml Ropivacaine 7,5mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml adrenaline 1 mg/ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption af analgesics |  | 96 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  | 96 h | 
| Mobilization level |  | 8 h | 
| Pain scores VAS |  | 96 h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Replacement, Hip, Anesthetics, Local, Pain, Postoperative