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OpenTrials
Completed

NCT Number: NCT01312298

General vs. Intrathecal Anesthesia for Total Knee Arthroplasty

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.

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Key information

Conditions

Arthritis Joint Diseases Musculoskeletal Diseases

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept orthopedic surgery at Hässleholm hospital

Hässlehom, 28125, Sweden

About this study

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:

  • Will general anesthesia produce less post operative pain?
  • Is there any difference in post operative orthostatic function (dizziness) between the groups?
  • Time until the patient meets the discharge criteria from PACU
  • How many patients will need at least one urinary bladder catheterization?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with osteoarthritis scheduled for surgery
  • patients that will require Total Knee Arthroplasty
  • patients over 45 yrs and under 85 yrs
  • patients that understand the given information and are willing to participate in this study
  • patients who have signed the informed consent document

Exclusion criteria

  • prior surgery to the same knee
  • patients with a history of stroke or neurological or psychiatric disease that potentially could affect the perception of pain
  • obesity (BMI> 35)
  • active or suspected infection
  • patients taking opioids or steroids
  • patients suffering from rheumatoid arthritis or have a immunological depression.
  • patients who are allergic to any of the drugs being used in this study
  • patients with other severe medical problems that could affect the perioperative course.

Treatment and study plan

General Anesthesia

Procedure

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

Other names: Suxamethonium 50 mg/ml is used to fascilitate intubation. Ventilation is done using oxygen and air.

Regional Anesthesia

Procedure

Patients will receive intrathecal anesthesia

Other names: Patients will receive bupivacaine 5 mg/ml intrathecally. Also the will receive propofol 10 mg/ml to produce a ligth level of sedation.

Primary outcomes

  1. time from end of surgery until patient is "street ready"

    Time frame: within 4 days after surgery

    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 outcomes

  1. Will general anesthesia produce less post operative pain as compared to intrathecal?

    Time frame: 48 hrs after surgery

    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.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Mar 10, 2011
Registry last updated
Mar 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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