General vs. Intrathecal Anesthesia for Total Knee Arthroplasty

NCT01312298 | Completed DMC

• 2 other identifiers: OpHas2011/3Copenhagen study 2011:1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis

Keywords

Arthritis; General anaesthesia; Spinal anaesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  48 hrs after surgery

Study Arms (2)

General Anesthesia

EXPERIMENTAL

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

Regional anesthesia

ACTIVE COMPARATOR

Patients will receive intrathecal anesthesia

Procedure: Regional anesthesia

Interventions

General anesthesia PROCEDURE

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

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

General Anesthesia

Regional anesthesia PROCEDURE

Patients will receive intrathecal anesthesia

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

Regional anesthesia

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Dept orthopedic surgery at Hässleholm hospital

Hässlehom, 28125, Sweden

Location

Related Publications (3)

• 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.

  PMID: 18211990 BACKGROUND

• 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.

  PMID: 9009936 BACKGROUND

• 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.

  PMID: 19025523 BACKGROUND

MeSH Terms

Conditions

Arthritis

Interventions

Anesthesia, General; Succinylcholine; Air; Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Sören Toksvig-Larsen, M.D. PhD

  Dept Ortopedic surgery, Hässleholm Hospital, SWEDEN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 10, 2011
• Study Start: August 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: January 1, 2013
• Last Updated: March 7, 2013

Record last verified: 2013-01

Locations

SE (1)