General vs. Intrathecal Anesthesia for Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Arthritis
• Interventions: Procedure: General anesthesia; Procedure: Regional anesthesia

• Registration Number: NCT01312298
• Lead Sponsor: Region Skane

Brief Summary

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

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:

1. Will general anesthesia produce less post operative pain?

2. Is there any difference in post operative orthostatic function (dizziness) between the groups?

3. Time until the patient meets the discharge criteria from PACU

4. How many patients will need at least one urinary bladder catheterization?

Study Timeline

• Study First Submitted: 2011-03-08
• Study First Submitted QC: 2011-03-09
• Study First Posted: 2011-03-10
• Study Start: 2011-08
• Primary Completion: 2012-06
• Status Verified: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-03-06
• Last Update Posted: 2013-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. patients with osteoarthritis scheduled for surgery
2. patients that will require Total Knee Arthroplasty
3. patients over 45 yrs and under 85 yrs
4. patients that understand the given information and are willing to participate in this study
5. patients who have signed the informed consent document

Exclusion Criteria

1. prior surgery to the same knee
2. patients with a history of stroke or neurological or psychiatric disease that potentially could affect the perception of pain
3. obesity (BMI> 35)
4. active or suspected infection
5. patients taking opioids or steroids
6. patients suffering from rheumatoid arthritis or have a immunological depression.
7. patients who are allergic to any of the drugs being used in this study
8. patients with other severe medical problems that could affect the perioperative course.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
General Anesthesia	General anesthesia	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)
Regional anesthesia	Regional anesthesia	Patients will receive intrathecal anesthesia

Primary Outcome Measures

Name	Time	Method
time from end of surgery until patient is "street ready"	within 4 days after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Will general anesthesia produce less post operative pain as compared to intrathecal?	48 hrs after surgery	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.

Trial Locations

Locations (1)

Dept orthopedic surgery at Hässleholm hospital; 🇸🇪 Hässlehom, Sweden