PACU Discharge Without Motorfunction Assessment After Spinal Anaesthesia
NCT ID: NCT02134496
Last Updated: 2016-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1511 participants
INTERVENTIONAL
2014-06-30
2015-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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no assessment of motorfunction in PACU
no assessment of motorfunction after spinal anesthesia in PACU
No interventions assigned to this group
motorfunction assessment in PACU
Assesment of motorfunction after spinal anesthesia
assessment of motorfunction in PACU
assessment of motorfunction in PACU after spinal anesthesia
Interventions
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assessment of motorfunction in PACU
assessment of motorfunction in PACU after spinal anesthesia
Eligibility Criteria
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Inclusion Criteria
* primary unilateral total hip or knee arthroplasty
* spinal anesthesia
Exclusion Criteria
* intraoperative bleeding exceeding 750 ml.
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Eske Kvanner Aasvang
M.D. DMSci
Principal Investigators
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Henrik Kehlet, Professor
Role: STUDY_CHAIR
Rigshospitalet, Denmark
Eske K Aasvang, M.D., DMSci
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Gentofte Hospital
Gentofte Municipality, International, Denmark
Vejle Sygehus
Vejle, International, Denmark
Farsø Sygehus
Farsø, , Denmark
Holstebro Sygehus
Holstebro, , Denmark
Viborg Hospital
Viborg, , Denmark
Countries
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References
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Aasvang EK, Laursen MB, Madsen J, Kroigaard M, Solgaard S, Kjaersgaard-Andersen P, Mandoe H, Hansen TB, Nielsen JU, Krarup N, Skott AE, Kehlet H. Incidence and related factors for intraoperative failed spinal anaesthesia for lower limb arthroplasty. Acta Anaesthesiol Scand. 2018 Aug;62(7):993-1000. doi: 10.1111/aas.13118. Epub 2018 Mar 26.
Other Identifiers
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H-1-2014-012
Identifier Type: -
Identifier Source: org_study_id