Arthritis Clinical Trial
Official title:
General vs. Intrathecal Anesthesia Fort Total Knee Arthroplasty; a Randomized Clinical Trial
Verified date | January 2013 |
Source | Region Skane |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: The National Board of Health and Welfare |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | January 2013 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years to 85 Years |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Dept orthopedic surgery at Hässleholm hospital | Hässlehom |
Lead Sponsor | Collaborator |
---|---|
Region Skane |
Sweden,
Andersen LØ, 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. — View 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. Review. — View Citation
Minto CF, Schnider TW, Shafer SL. Pharmacokinetics and pharmacodynamics of remifentanil. II. Model application. Anesthesiology. 1997 Jan;86(1):24-33. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
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