General vs. Intrathecal Anesthesia for Total Knee Arthroplasty

Study Overview
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Brief Summary
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Hypothesis: General anesthesia as compared to intrathecal (i.e. spinal anesthesia) anesthesia will result in shorter length of hospital stay for patients undergoing total knee arthroplasty. Primary endpoint: time from end of surgery until the patient is street ready Secondary endpoints: will general anesthesia produce less postoperative pain as compared to intrathecal anesthesia? Is there any difference in post operative dizziness between the groups.

Detailed Description
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Hypothesis: General anaesthesia compared to intrathecal anaesthesia will give shorter length of hospital stay (LOS) for patients undergoing total knee arthroplasty (TKA). Primary endpoint: time from end of surgery until the patient meets the discharge criteria. Secondary endpoints: Will general anesthesia produce less post operative pain? Is there any difference in post operative orthostatic function (dizziness) between the groups? Time until the patient meets the discharge criteria from PACU How many patients will need at least one urinary bladder catheterization?

Official Title
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General vs. Intrathecal Anesthesia Fort Total Knee Arthroplasty; a Randomized Clinical Trial

Conditions
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Arthritis

Intervention / Treatment
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* Procedure: General anesthesia
* Procedure: Regional anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with osteoarthritis scheduled for surgery patients that will require Total Knee Arthroplasty patients over 45 yrs and under 85 yrs patients that understand the given information and are willing to participate in this study patients who have signed the informed consent document Exclusion Criteria: prior surgery to the same knee patients with a history of stroke or neurological or psychiatric disease that potentially could affect the perception of pain obesity (BMI> 35) active or suspected infection patients taking opioids or steroids patients suffering from rheumatoid arthritis or have a immunological depression. patients who are allergic to any of the drugs being used in this study patients with other severe medical problems that could affect the perioperative course.

Ages Eligible for Study
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Minimum Age: 45 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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: General Anesthesia<br>Patients allocated to this arm will receive general anesthesia using propofol 10 mg/ml and remifentanil 50 ug/ml in a Target Controlled Infusion (TCI) | Procedure: General anesthesia<br>* Patients will receive general anesthesia using propofol 10 mg/ml and remifentanil 50 ug/ml<br>* Other names: Suxamethonium 50 mg/ml is used to fascilitate intubation. Ventilation is done using oxygen and air.;|
| Active Comparator: Regional anesthesia<br>Patients will receive intrathecal anesthesia | Procedure: Regional anesthesia<br>* Patients will receive intrathecal anesthesia<br>* Other names: Patients will receive bupivacaine 5 mg/ml intrathecally. Also the will receive propofol 10 mg/ml to produce a ligth level of sedation.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time from end of surgery until patient is street ready | Time from end of surgery until the patient is street ready will be monitored. If the patient is street ready will be evaluated twice daily each day after the surgery. | within 4 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Will general anesthesia produce less post operative pain as compared to intrathecal? | Pain will be measured using a visual analogue scale. The patient's own evaluation (questionnaires about quality of life and knee function) Time of post-op department, total time in hospital. Evaluation of patient outcomes, clinical and radiographic evaluation will be done before surgery, after surgery, and after 3 months, after 1year Data collection will be done through normal medical records and patient evaluations collected in a separate file in the clinic. Data is collected and processed by the Research Unit at the orthopedic clinic in Hässleholm. | 48 hrs after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthritis, General anaesthesia, Spinal anaesthesia