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General vs. Intrathecal Anesthesia for Total Knee Arthroplasty

Primary Purpose

Arthritis

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

General anesthesia

Regional anesthesia

About this trial

This is an interventional treatment trial for Arthritis focused on measuring Arthritis, General anaesthesia, Spinal anaesthesia

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Dept orthopedic surgery at Hässleholm hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

General Anesthesia

Regional anesthesia

Arm Description

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)

Patients will receive intrathecal anesthesia

Outcomes

Primary Outcome Measures

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

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?

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.

Full Information

NCT ID

NCT01312298

First Posted

March 8, 2011

Last Updated

March 6, 2013

Sponsor

Region Skane

1. Study Identification

Unique Protocol Identification Number

NCT01312298

Brief Title

General vs. Intrathecal Anesthesia for Total Knee Arthroplasty

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Region Skane

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis

Keywords

Arthritis, General anaesthesia, Spinal anaesthesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

General Anesthesia

Arm Type

Experimental

Arm Description

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)

Arm Title

Regional anesthesia

Arm Type

Active Comparator

Arm Description

Patients will receive intrathecal anesthesia

Intervention Type

Procedure

Intervention Name(s)

General anesthesia

Other Intervention Name(s)

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

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Regional anesthesia

Other Intervention Name(s)

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

Intervention Description

Patients will receive intrathecal anesthesia

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

within 4 days after surgery

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

48 hrs after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sören Toksvig-Larsen, M.D. PhD

Organizational Affiliation

Dept Ortopedic surgery, Hässleholm Hospital, SWEDEN

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept orthopedic surgery at Hässleholm hospital

City

Hässlehom

ZIP/Postal Code

28125

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

18211990

Citation

Fowler SJ, Symons J, Sabato S, Myles PS. Epidural analgesia compared with peripheral nerve blockade after major knee surgery: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2008 Feb;100(2):154-64. doi: 10.1093/bja/aem373.

Results Reference

background

PubMed Identifier

9009936

Citation

Minto CF, Schnider TW, Shafer SL. Pharmacokinetics and pharmacodynamics of remifentanil. II. Model application. Anesthesiology. 1997 Jan;86(1):24-33. doi: 10.1097/00000542-199701000-00005.

Results Reference

background

PubMed Identifier

19025523

Citation

Andersen LO, Husted H, Otte KS, Kristensen BB, Kehlet H. High-volume infiltration analgesia in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2008 Nov;52(10):1331-5. doi: 10.1111/j.1399-6576.2008.01777.x.

Results Reference

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General vs. Intrathecal Anesthesia for Total Knee Arthroplasty

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