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.

Study Overview

• Status: Completed
• Conditions: Arthritis
• Intervention / Treatment: Procedure: General anesthesia; Procedure: Regional anesthesia

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?

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Hässlehom, Sweden, 28125
    • Dept orthopedic surgery at Hässleholm hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Patients will receive bupivacaine 5 mg/ml intrathecally. Also the will receive propofol 10 mg/ml to produce a ligth level of sedation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 4 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hrs after surgery

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Sören Toksvig-Larsen, M.D. PhD, Dept Ortopedic surgery, Hässleholm Hospital, SWEDEN

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: March 8, 2011
• First Submitted That Met QC Criteria: March 9, 2011
• First Posted (Estimate): March 10, 2011

Study Record Updates

• Last Update Posted (Estimate): March 7, 2013
• Last Update Submitted That Met QC Criteria: March 6, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Arthritis; General anaesthesia; Spinal anaesthesia
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Hypnotics and Sedatives; Anesthetics, Local; Neuromuscular Agents; Neuromuscular Blocking Agents; Neuromuscular Depolarizing Agents; Anesthetics; Propofol; Bupivacaine; Succinylcholine
• Other Study ID Numbers: OpHas2011/3; Copenhagen study 2011:1 (Other Grant/Funding Number: Region Skane, SWEDEN)