General vs. Intrathecal Anesthesia for Total Knee Arthroplasty

Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312298
• Other study ID #: OpHas2011/3
• Secondary ID: Copenhagen study
• Status: Completed
• Phase: N/A
• First received: March 8, 2011
• Last updated: March 6, 2013
• Start date: August 2011
• Est. completion date: January 2013

Study information

• 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

Clinical Trial 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.

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?

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis

Intervention

Procedure:
• General anesthesia
Patients will receive general anesthesia using propofol 10 mg/ml and remifentanil 50 ug/ml
• Regional anesthesia
Patients will receive intrathecal anesthesia

Locations

Country	Name	City	State
Sweden	Dept orthopedic surgery at Hässleholm hospital	Hässlehom

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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

Outcome

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

External Links

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