Effect of Local Infiltration Anesthesia With Ropivacaine on Pain After Primary Total Hip Arthroplasty

Study Overview
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Brief Summary
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Background: The Local infiltration analgesic (LIA) technique has been widely used to reduce opioid requirements and improve the patient's mobilization after total hip arthroplasty (THA). However, the evidence for LIA in THA remains to be clarified. Purpose: To evaluate whether a single shot LIA in addition to a multimodal analgesic regimen reduces acute postoperative pain and opioid requirements after THA.

Official Title
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Effect of Local Infiltration Anesthesia With Ropivacaine on Pain After Primary Total Hip Arthroplasty

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Procedure: local infiltration anesthesia using Ropivacaine and Epinephrine
* Procedure: local infiltration anesthesia using saline
* Procedure: Multimodal analgesic regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients receiving total hip arthroplasty in the study period Exclusion Criteria: contraindications to receive spinal anesthetic, Dexamethasone or Acetaminophen. Patients who received general anaesthetic patients who will get a different operation than standard direct lateral surgery Patients with osteosynthesis to be removed in the same operation
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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: LIA placebo<br>local infiltration anesthesia using saline i addition to multimodal analgesic regimen | Procedure: local infiltration anesthesia using saline<br>* 150 ml 0,9% saline: The first 50 ml will be injected in the periacetabular tissue after insertion of the acetabular component. After insertion of the femoral component, 50 ml will be inserted in the gluteus muscles and the proximal part of the iliotibial tract. The last 50 ml will be inserted in the subcutaneous layer.<br>Procedure: Multimodal analgesic regimen<br>* All patients will be operated under spinal anaesthesia with 2.0-3.0 ml Bupivacaine 0.5 % plain, preferably at the L2/L3 alternatively the L3/L4 vertebral interspace. Propofol infusion will be administrated for sedation if needed. Postoperative morphine will be given as needed intravenously when needed. After transfer to a specialized hip arthroplasty unit with a well-defined and experienced program for multimodal rehabilitation, multimodal oral opioid-sparing analgesia will be given to all patients; NSAIDS and Acetaminophen will be given at regular intervals and Oxycodone as needed.<br>|
| Experimental: LIA Ropivacaine<br>local infiltration anesthesia using Ropivacaine and Epinephrine i addition to multimodal analgesic regimen | Procedure: local infiltration anesthesia using Ropivacaine and Epinephrine<br>* 150 ml Ropivacaine 2mg/ml + 0,5 ml Epinephrine 1 mg/ml: The first 50 ml will be injected in the periacetabular tissue after insertion of the acetabular component. After insertion of the femoral component, 50 ml will be inserted in the gluteus muscles and the proximal part of the iliotibial tract. The last 50 ml will be inserted in the subcutaneous layer.<br>Procedure: Multimodal analgesic regimen<br>* All patients will be operated under spinal anaesthesia with 2.0-3.0 ml Bupivacaine 0.5 % plain, preferably at the L2/L3 alternatively the L3/L4 vertebral interspace. Propofol infusion will be administrated for sedation if needed. Postoperative morphine will be given as needed intravenously when needed. After transfer to a specialized hip arthroplasty unit with a well-defined and experienced program for multimodal rehabilitation, multimodal oral opioid-sparing analgesia will be given to all patients; NSAIDS and Acetaminophen will be given at regular intervals and Oxycodone as needed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain assessed by numeric rating scale | assessed by numeric rating scale | 1 day (first postoperative day) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Replacement, Hip, Anesthesia, Local, Ropivacaine, Randomized controlled trial