Local Continuous Wound Infusion of Anesthetics in the Management of Post-operative Pain After Total Hip Arthroplasty.

Study Overview
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Brief Summary
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The combination of subarachnoid anaesthesia (SAB) and continuous local wound infiltration (LCWI) with a consistent amount of local anaesthetics could prevent central sensitization through an additive or synergistic effect because it can maintain continuous inhibition of nociceptive afferents

Detailed Description
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Wound infiltration with local anesthetics is an analgesic technique that has been adopted for post-operative analgesia following a range of surgical orthopaedic procedures. Pain management by infusion of local aesthetic into wounds was found to improve pain, reduced opioid use and side effects, increase patient satisfaction, and shorten the hospital stay when compared to placebo or no treatment, but actually it was not definitively proven that wound infiltration provides additional analgesic or outcome benefit in the setting of a comprehensive multimodal analgesic approach. The hypothesis of this study is that a consistent amount of Levobupivacaine 0.5% for LCWI and LIA could provide a more extended postoperative analgesia for post-operative incident and rest pain with a better post-operative recovery and rehabilitation following THA, in the first 72 hours after surgery.

Official Title
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Local Continuous Wound Infusion and Local Infusion of Anaesthetics in the Management of Post-operative Pain and Rehabilitation After Total Hip Arthroplasty: a Double-blind Randomized Controlled Clinical Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: Levobupivacaine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-90 years of age American Society of Anaesthesiologists (ASA) physical status I-III total hip arthroplasty. Exclusion Criteria: pregnancy body mass index (BMI) >35 allergy to local anaesthetics skeletal and/or muscle abnormalities of the spine primary and/or secondary neurological diseases psychiatric diseases history of chronic pain and/or neuropathic disorders history of drug abuse state of sepsis infection and/or tumours within the skin on the back primary or secondary coagulopathies primary or secondary heart, liver and renal failure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levobupivacaine infusion<br>1500 mg of Levobupivacaine by an infusion rate of 10 ml/h for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected. | Drug: Levobupivacaine<br>* An infusion rate of 10 ml/h of 1500 mg of 0.5 % of levobupivacaine for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected into the surgical wound.<br>* Other names: Chiracaine;|
| Placebo Comparator: Saline infusion<br>300 ml of Saline (for Levobupivacaine as placebo) by an infusion rate of 10 ml/h for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected. | Drug: Saline<br>* An infusion rate of 10 ml/h of 300 ml of saline solution for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected into the surgical wound.<br>* Other names: Saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident and rest pain (using VAS score) at 72 hours after surgery | The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable). | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of painkillers (in mg) at 72 hours after surgery | The equianalgesic dose (in mg) of morphine | 72 hours | 
| Side effects (PONV) at 72 hours after surgery | Time to have post-operative nausea and vomiting (in minutes) | 72 hours | 
| Toxicity of local anaesthetics (epilepsy) at 72 hours after surgery | Presence or not of epilepsy | 72 hours | 
| Wound healing at 72 hours | Number of infections of surgical wound. | 72 hours | 
| Improvement of rehabilitation at 72 hours | Our total hip arthroplasy rehabilitation protocol is focused on the following manoeuvres: contraction of the gluteal and quadricipital muscles, passive and active mobilization of the hip joint, passive and active mobilization of the knee and walking with crutches and a walker.the improvement of rehabilitation manoeuvres has been evaluated in a four-step scale: 0-no improvement; 1- slight improvement, 2- good improvement; 3- great improvement. | 72 hours |