Osteoarthritis Susceptibility 3 Clinical Trial
Official title:
PACU Discharge Without Motorfunction Assessment After Spinal Anaesthesia for Total Hip or Knee Arthroplasty - a Multicenter Randomized Controlled Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment