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

Phase 4

• Conditions: Total Knee Replacement Surgery
• Interventions: Drug: General anesthetic; Drug: Spinal Block; Device: Total knee replacement

• Registration Number: NCT03176758
• Lead Sponsor: Meir Medical Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2017-05-21
• Status Verified: 2017-06
• Study Start: 2017-06-01
• Study First Submitted QC: 2017-06-02
• Last Update Submitted: 2017-06-02
• Study First Posted: 2017-06-05
• Last Update Posted: 2017-06-05
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• all patient who will undergo total knee arthroplasty

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Exclusion Criteria

• patients who will not agree to participate in the study
• patients who will die during the research timeframe

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia	Total knee replacement	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)
Spinal block	Total knee replacement	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)
General anesthesia	General anesthetic	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)
Spinal block	Spinal Block	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)

Primary Outcome Measures

Name	Time	Method
postoperative pain measured by Visual Analogue Scale	48 hours	Visual Analogue Scale scores of pain will be documented at different timed during the first 48 postoperative hours

Secondary Outcome Measures

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