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Recovery at the Post Anaesthetic Care Unit After Hip and Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT01178489
Recruitment Status : Completed
First Posted : August 10, 2010
Last Update Posted : September 22, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To clarify patient related problems in the Post Anaesthetic Care Unit (PACU) immediately after fast-track hip and knee arthroplasty.

Condition or disease
PACU Stay After THA Under Spinal Anaesthesia PACU Stay After TKA Under Spinal Anaesthesia

Detailed Description:

In this prospective, consecutive, observational cohort study we examine:

  1. Patient related problems in the PACU after hip and knee arthroplasty simply to answer the question "Why in PACU?", using a modified version of the national guidelines for patient observation in PACU.
  2. The time spent in PACU with the modified version of the national guidelines for patient observation in PACU.
  3. If the modified version of the national guidelines for patient observation in PACU results in patient related problems in the ward afterwards.

Study Design

Study Type : Observational
Actual Enrollment : 170 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Recovery at the Post Anaesthetic Care Unit After Fast-track Hip and Knee Arthroplasty
Study Start Date : August 2010
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Patients undergoing arthroplasty
Patients undergoing primary, unilateral, total hip or knee arthroplasty under spinal anaesthesia


Outcome Measures

Primary Outcome Measures :
  1. Time to meet PACU discharge criteria [ Time Frame: 3 hours ]

Secondary Outcome Measures :
  1. Actual discharge time from PACU [ Time Frame: 3 hours ]
  2. Clinical and logistic factors detaining patients in PACU [ Time Frame: 3 hours ]
  3. Potential complications at the surgical ward [ Time Frame: 24 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing primary, unilateral, total hip or knee arthroplasty
Criteria

Inclusion Criteria:

  • primary, unilateral, total hip or knee arthroplasty by one of three surgeons using the same technique, and under spinal anaesthesia

Exclusion Criteria:

  • Bilateral arthroplasty
  • Revision arthroplasty
  • General anaesthesia
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01178489


Locations
Denmark
Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Troels H Lunn, M.D. Hvidovre University Hospital
More Information

Responsible Party: Troels Haxholdt Lunn, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01178489     History of Changes
Other Study ID Numbers: H-1-2010-FSP
First Posted: August 10, 2010    Key Record Dates
Last Update Posted: September 22, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs