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General vs. Intrathecal Anesthesia for Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01312298
First received: March 8, 2011
Last updated: March 6, 2013
Last verified: January 2013
History of Changes

March 8, 2011
March 6, 2013
August 2011
June 2012   (final data collection date for primary outcome measure)
time from end of surgery until patient is "street ready" [ Time Frame: within 4 days after surgery ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01312298 on ClinicalTrials.gov Archive Site
Will general anesthesia produce less post operative pain as compared to intrathecal? [ Time Frame: 48 hrs after surgery ] [ Designated as safety issue: No ]

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.
Will general anesthesia produce less post operative pain as compared to intrathecal? [ Time Frame: 48 hrs after surgery ] [ Designated as safety issue: No ]
Pain will be measured using a visual analogue scale.
Not Provided
Not Provided
 
General vs. Intrathecal Anesthesia for Total Knee Arthroplasty
General vs. Intrathecal Anesthesia Fort Total Knee Arthroplasty; a Randomized Clinical Trial

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.

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?
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Arthritis
  • Procedure: General anesthesia
    Patients will receive general anesthesia using propofol 10 mg/ml and remifentanil 50 ug/ml
    Other Name: Suxamethonium 50 mg/ml is used to fascilitate intubation. Ventilation is done using oxygen and air.
  • Procedure: Regional anesthesia
    Patients will receive intrathecal anesthesia
    Other Name: Patients will receive bupivacaine 5 mg/ml intrathecally. Also the will receive propofol 10 mg/ml to produce a ligth level of sedation.
  • Experimental: 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)
    Intervention: Procedure: General anesthesia
  • Active Comparator: Regional anesthesia
    Patients will receive intrathecal anesthesia
    Intervention: Procedure: Regional anesthesia

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
January 2013
June 2012   (final data collection date for primary outcome measure)

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.
Both
45 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01312298
OpHas2011/3, Copenhagen study 2011:1
Yes
Region Skane
Region Skane
Not Provided
Principal Investigator: Sören Toksvig-Larsen, M.D. PhD Dept Ortopedic surgery, Hässleholm Hospital, SWEDEN
Region Skane
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP