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PACU Discharge Without Motorfunction Assessment After Spinal Anaesthesia

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ClinicalTrials.gov Identifier: NCT02134496
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Eske Kvanner Aasvang, Rigshospitalet, Denmark

Brief Summary:

The study investigates the safety of discharge from the Post-Anesthesia Care Unit (PACU) without assessment of motorfunction after spinal anesthesia for total hip- or knee replacement. This is an randomized controlled trial between two groups with assessment of normal (Aldrete) PACU discharge criteria with or without assessment of the motorfunction. The study hypothesis is that it is safe to be discharged from the PACU to a ward without assessment of motor function.

The main outcome is length of hospial stay (LOS) in days and re-admission within the first 30 days after surgery .

Secondary outcomes include adverse events up to 24 hours after surgery, and minuttes spent in the PACU after surgery.

Participants will be monitores for adverse events for the first 24 hours after surgery and reported. The total number of minuttes spent in the PACU will be recorded and reported.


Condition or disease Intervention/treatment Phase
Osteoarthritis Susceptibility 3 Procedure: assessment of motorfunction in PACU Not Applicable

Detailed Description:

A novel analysis of the latest database version was performed 06.04.2015, showing that 86.7% of patients have LOS of less than 5 days and no re-admission within the first 30 days after discharge.

The study is designed as a non-inferiority study with a two-sided 5% significance level, 80% power and a non-inferiority level of 5%, resulting in 2 x 725 patients (1500 in total including drop-outs).

A 30-day re-admission period was chosen to detect complications that could be assumed to have occurred as a consequence of the potential earlier PACU discharge The study will also investigate Length of stay, incidence of failed anesthesia, and reason for stay in PACU after THA and TKA 24.11.2016 A substudy based upon the un-published data from the time in PACU will be performed to analyse factors related to adverse events occuring during the PACU stay, and description of specific organdysfunction based upon the recordings from the modifed Aldrete discharge criteria.

Preoperative demographic data are collected from charts and the Lundbeck Centre for Fast-track Hip and Knee Replacement database, (LCDB), intraoperative data from anesthesia charts.

A logistic regression analysis will be performed with the YES/NO outcome of moderate/severe adverse PACU events at any time during PACU stay, and pre- and intr operatie variables.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1511 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PACU Discharge Without Motorfunction Assessment After Spinal Anaesthesia for Total Hip or Knee Arthroplasty - a Multicenter Randomized Controlled Trial
Study Start Date : June 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
No Intervention: no assessment of motorfunction in PACU
no assessment of motorfunction after spinal anesthesia in PACU
Active Comparator: motorfunction assessment in PACU
Assesment of motorfunction after spinal anesthesia
Procedure: assessment of motorfunction in PACU
assessment of motorfunction in PACU after spinal anesthesia




Primary Outcome Measures :
  1. Lenght of stay (in days) or 30 day readmissions [ Time Frame: 30 days ]
    The main outcome is a compund measure of the duration of hospitalization after operation )measured in days, and named Length of Stay LOS) adn/or re-admission within the first 30 days after discharge.


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 24 hours postooperatively ]
    Any event that results in a physicians assessment of the patient, not including regular rounds during the first 24 hours after surgery.


Other Outcome Measures:
  1. Time to discharge from PACU [ Time Frame: 12 hours ]
    Time from arrival to discharge i PACU measured in minuttes

  2. Discharge readiness before leaving the operating theater [ Time Frame: 1 hour ]
    How many patients fulfilled the PACU discahrge criteria at the time they were leaving the operating theater

  3. Failed spinal anesthesia. [ Time Frame: 6 hours. ]
    Incidence and related factors to failed spinal anesthesia (ie. conversion to generel anesthesia)

  4. Prediction of PACU complications [ Time Frame: 0-7 hours ]
    Factors related to, and incidence of, moderate/severe complications i PACU



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18 yr or more
  • primary unilateral total hip or knee arthroplasty
  • spinal anesthesia

Exclusion Criteria:

  • intraoperative conversion to general anesthesia
  • intraoperative bleeding exceeding 750 ml.

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): NCT02134496


Locations
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Denmark
Gentofte Hospital
Gentofte, International, Denmark, 2900
Vejle Sygehus
Vejle, International, Denmark, 7100
Farsø Sygehus
Farsø, Denmark, 4640
Holstebro Sygehus
Holstebro, Denmark
Viborg Hospital
Viborg, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Study Chair: Henrik Kehlet, Professor Rigshospitalet, Denmark
Principal Investigator: Eske K Aasvang, M.D., DMSci Rigshospitalet, Denmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eske Kvanner Aasvang, M.D. DMSci, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02134496    
Other Study ID Numbers: H-1-2014-012
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016
Keywords provided by Eske Kvanner Aasvang, Rigshospitalet, Denmark:
hip
knee
arthroplasty
spinal
anesthesia
Additional relevant MeSH terms:
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Osteoarthritis
Disease Susceptibility
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Disease Attributes
Pathologic Processes