Osteoarthritis Susceptibility 3
Conditions
Keywords
hip, knee, arthroplasty, spinal, anesthesia
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.
Interventions
PROCEDUREassessment of motorfunction in PACU
assessment of motorfunction in PACU after spinal anesthesia
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lenght of stay (in days) or 30 day readmissions | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to discharge from PACU | 12 hours | Time from arrival to discharge i PACU measured in minuttes |
| Discharge readiness before leaving the operating theater | 1 hour | How many patients fulfilled the PACU discahrge criteria at the time they were leaving the operating theater |
| Failed spinal anesthesia. | 6 hours. | Incidence and related factors to failed spinal anesthesia (ie. conversion to generel anesthesia) |
| Prediction of PACU complications | 0-7 hours | Factors related to, and incidence of, moderate/severe complications i PACU |
Countries
Denmark
Outcome results
None listed