Clinical trial NCT02134496: PACU Discharge Without Motorfunction Assessment After Spinal Anaesthesia
Official title: PACU Discharge Without Motorfunction Assessment After Spinal Anaesthesia for Total Hip or Knee Arthroplasty - a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis Susceptibility 3
Keywords: hip
knee
arthroplasty
spinal
anesthesia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-05-09
Enrollment: 1511
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Lenght of stay (in days) or 30 day readmissions
timeFrame: 30 days
Secondary outcomes:
measure: Adverse events
timeFrame: 24 hours postooperatively
Other outcomes:
measure: Time to discharge from PACU
timeFrame: 12 hours
measure: Discharge readiness before leaving the operating theater
timeFrame: 1 hour
measure: Failed spinal anesthesia.
timeFrame: 6 hours.
measure: Prediction of PACU complications
timeFrame: 0-7 hours
Locations:
city: Gentofte
country: Denmark
facility: Gentofte Hospital
state: International
city: Vejle
country: Denmark
facility: Vejle Sygehus
state: International
city: Farsø
country: Denmark
facility: Farsø Sygehus
city: Holstebro
country: Denmark
facility: Holstebro Sygehus
city: Viborg
country: Denmark
facility: Viborg Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Henrik Kehlet, Professor
role: STUDY_CHAIR
affiliation: Rigshospitalet, Denmark
name: Eske K Aasvang, M.D., DMSci
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.