General vs. Intrathecal Anesthesia for Total Knee Arthroplasty
Primary Purpose
Arthritis
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
General anesthesia
Regional anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis focused on measuring Arthritis, General anaesthesia, Spinal anaesthesia
Eligibility Criteria
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.
Sites / Locations
- Dept orthopedic surgery at Hässleholm hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
General Anesthesia
Regional anesthesia
Arm Description
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)
Patients will receive intrathecal anesthesia
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01312298
Brief Title
General vs. Intrathecal Anesthesia for Total Knee Arthroplasty
Official Title
General vs. Intrathecal Anesthesia Fort Total Knee Arthroplasty; a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis
Keywords
Arthritis, General anaesthesia, Spinal anaesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
General Anesthesia
Arm Type
Experimental
Arm Description
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)
Arm Title
Regional anesthesia
Arm Type
Active Comparator
Arm Description
Patients will receive intrathecal anesthesia
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Other Intervention Name(s)
Suxamethonium 50 mg/ml is used to fascilitate intubation. Ventilation is done using oxygen and air.
Intervention Description
Patients will receive general anesthesia using propofol 10 mg/ml and remifentanil 50 ug/ml
Intervention Type
Procedure
Intervention Name(s)
Regional anesthesia
Other Intervention Name(s)
Patients will receive bupivacaine 5 mg/ml intrathecally. Also the will receive propofol 10 mg/ml to produce a ligth level of sedation.
Intervention Description
Patients will receive intrathecal anesthesia
Primary Outcome Measure Information:
Title
time from end of surgery until patient is "street ready"
Description
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.
Time Frame
within 4 days after surgery
Secondary Outcome Measure Information:
Title
Will general anesthesia produce less post operative pain as compared to intrathecal?
Description
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.
Time Frame
48 hrs after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sören Toksvig-Larsen, M.D. PhD
Organizational Affiliation
Dept Ortopedic surgery, Hässleholm Hospital, SWEDEN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept orthopedic surgery at Hässleholm hospital
City
Hässlehom
ZIP/Postal Code
28125
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
18211990
Citation
Fowler SJ, Symons J, Sabato S, Myles PS. Epidural analgesia compared with peripheral nerve blockade after major knee surgery: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2008 Feb;100(2):154-64. doi: 10.1093/bja/aem373.
Results Reference
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PubMed Identifier
9009936
Citation
Minto CF, Schnider TW, Shafer SL. Pharmacokinetics and pharmacodynamics of remifentanil. II. Model application. Anesthesiology. 1997 Jan;86(1):24-33. doi: 10.1097/00000542-199701000-00005.
Results Reference
background
PubMed Identifier
19025523
Citation
Andersen LO, Husted H, Otte KS, Kristensen BB, Kehlet H. High-volume infiltration analgesia in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2008 Nov;52(10):1331-5. doi: 10.1111/j.1399-6576.2008.01777.x.
Results Reference
background
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General vs. Intrathecal Anesthesia for Total Knee Arthroplasty
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