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General vs. Intrathecal Anesthesia for Total Knee Arthroplasty

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01312298
Enrollment
120
Registered
2011-03-10
Start date
2011-08-31
Completion date
2013-01-31
Last updated
2013-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis

Keywords

Arthritis, General anaesthesia, Spinal anaesthesia

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?

Interventions

PROCEDUREGeneral anesthesia

Patients will receive general anesthesia using propofol 10 mg/ml and remifentanil 50 ug/ml

PROCEDURERegional anesthesia

Patients will receive intrathecal anesthesia

Sponsors

Region Skane
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
time from end of surgery until patient is street readywithin 4 days after surgeryTime 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

MeasureTime frameDescription
Will general anesthesia produce less post operative pain as compared to intrathecal?48 hrs after surgeryPain 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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026