General vs. Intrathecal Anesthesia for Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Early Mobilization After Total Knee Arthroplasty

NCT01604382

Osteoarthritis

COMPLETED NA

General Anaesthesia vs Spinal Anaesthesia: Patient Outcomes and Success in Outpatient Primary Total Knee and Hip Arthroplasty

NCT07334132

Osteo Arthritis Knee and Hip Osteo Arthritis Inflammatory Joint Disease (IJD)

NOT_YET_RECRUITING PHASE4

Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia

NCT03364088

Knee Osteoarthritis Arthropathy of Knee Joint Knee Pain Chronic +2 more

COMPLETED NA

Total Knee Replacement Under Spinal Anesthesia, Comparison of Postoperative Recovery Versus General Anesthesia

NCT07275983

Total Knee Replacement

RECRUITING

Postoperative Pain in Total Knee Arthroplasty: a Comparison Between General and Spinal Anesthesia

NCT03176758

Total Knee Replacement Surgery

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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?

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

General anesthesia

Intervention Type PROCEDURE

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

Regional anesthesia

Patients will receive intrathecal anesthesia

Group Type ACTIVE_COMPARATOR

Regional anesthesia

Intervention Type PROCEDURE

Patients will receive intrathecal anesthesia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

General anesthesia

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

Intervention Type PROCEDURE

Regional anesthesia

Patients will receive intrathecal anesthesia

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Suxamethonium 50 mg/ml is used to fascilitate intubation. Ventilation is done using oxygen and air. Patients will receive bupivacaine 5 mg/ml intrathecally. Also the will receive propofol 10 mg/ml to produce a ligth level of sedation.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No