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
  Purpose

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.


Condition Intervention
Arthritis
Procedure: General anesthesia
Procedure: Regional anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: General vs. Intrathecal Anesthesia Fort Total Knee Arthroplasty; a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 120
Study Start Date: August 2011
Study Completion Date: January 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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.
Active Comparator: Regional anesthesia
Patients will receive intrathecal anesthesia
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.

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?
  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312298

Locations
Sweden
Dept orthopedic surgery at Hässleholm hospital
Hässlehom, Sweden, 28125
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Sören Toksvig-Larsen, M.D. PhD Dept Ortopedic surgery, Hässleholm Hospital, SWEDEN
  More Information

Additional Information:
Publications:
Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01312298     History of Changes
Other Study ID Numbers: OpHas2011/3, Copenhagen study 2011:1
Study First Received: March 8, 2011
Last Updated: March 6, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Region Skane:
Arthritis
General anaesthesia
Spinal anaesthesia

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases
Anesthetics
Propofol
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014