Postoperative Pain in Total Knee Arthroplasty: a Comparison Between General and Spinal Anesthesia

Study Overview
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Brief Summary
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Total knee arthroplasty may be conducted either under general anesthesia or spinal block. previous studies have shown that spinal block leads to less complications. The investigators aim to find whether post-operative pain is also diminished under spinal block compared to general anesthesia

Detailed Description
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Patients who will be registered for a total knee replacement in Meir Medical Center and that will agree to participate in the study will be enrolled into one of two groups: the first, which will be the default choice for all patients, will be operated under a spinal block. Patients who will ask specifically for general anesthesia, or those in which the anesthesiologist will prefer general anesthesia due to medical reasons will be enrolled into the second group. For both groups the surgeon will add intraoperative peri-articular infiltration of local Marcaine injections, which was previously shown to diminish postoperative pain. The postoperative pain will be evaluated with the Visual Analogue Scale at different point during the first 48 hours following operation. Physiotherapy achievements will also be recorded. The investigators will try to find whether one of the two groups suffered less pain or had achieved better results in physical therapy.

Official Title
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Postoperative Pain in Total Knee Arthroplasty: a Comparison Between General and Spinal Anesthesia

Conditions
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Total Knee Replacement Surgery

Intervention / Treatment
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* Drug: Spinal Block
* Drug: General anesthetic
* Device: Total knee replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patient who will undergo total knee arthroplasty Exclusion Criteria: patients who will not agree to participate in the study patients who will die during the research timeframe

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The participant will be non-randomly enrolled into two groups. The default treatment, which was found as the preferred method by numerous investigators will be offered to all participants. Those who will ask for the second option (general anesthesia) or those who will not be aligble for spinlal block will be enrolled in the second group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spinal block<br>Intrathecal 10 mg Heavy Marcaine, 200 mcg Morphine + High volume local anesthesia infiltration Bupivacaine 5mg/ml + adrenaline 5 mcg/ml 3mg/kg ideal body weight diluted with 100cc Normal Saline + Total Knee Replacement ( which will not be the intervention of interest) | Drug: Spinal Block<br>* Intrathecal 10 mg Heavy Marcaine, 200 mcg Morphine + High volume local anesthesia infiltration Bupivacaine 5mg/ml + adrenaline 5 mcg/ml 3mg/kg IBW diluted with 100cc Normal Saline<br>* Other names: Neurological block;Device: Total knee replacement<br>* A total knee arthroplasty surgery, which is not the intervention of interest<br>|
| Active Comparator: General anesthesia<br>1-3 mg IV propofol 0.5 mg/kg IV Rocuronium + Fentanyl 2-3 mcg/kg + Morphine 0.1mg/kg IV Maintenance: Volatile anesthetic + High volume local anesthesia infiltration Bupivacaine 5mg/ml + adrenaline 5 mcg/ml 3mg/kg ideal body weight diluted with 100cc Normal Saline + Total Knee Replacement ( which will not be the intervention of interest) | Drug: General anesthetic<br>* 1-3 mg IV propofol 0.5 mg/kg IV Rocuronium + Fentanyl 2-3 mcg/kg + Morphine 0.1mg/kg IV Maintenance: Volatile anesthetic + High volume local anesthesia infiltration Bupivacaine 5mg/ml + adrenaline 5 mcg/ml 3mg/kg IBW diluted with 100cc Normal Saline<br>Device: Total knee replacement<br>* A total knee arthroplasty surgery, which is not the intervention of interest<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain measured by Visual Analogue Scale | Visual Analogue Scale scores of pain will be documented at different timed during the first 48 postoperative hours | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievements in physical therapy measured by walking distance on the first postoperative day | The patient will walk with a walker under the surgeon's supervision, and the surgeon will measure with the distance the succeeded walking | 24 hours |