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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1511 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- Time to discharge from PACU [ Time Frame: 12 hours ]Time from arrival to discharge i PACU measured in minuttes
- 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
- Failed spinal anesthesia. [ Time Frame: 6 hours. ]Incidence and related factors to failed spinal anesthesia (ie. conversion to generel anesthesia)
- Prediction of PACU complications [ Time Frame: 0-7 hours ]Factors related to, and incidence of, moderate/severe complications i PACU
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
|Gentofte, International, Denmark, 2900|
|Vejle, International, Denmark, 7100|
|Farsø, Denmark, 4640|
|Study Chair:||Henrik Kehlet, Professor||Rigshospitalet, Denmark|
|Principal Investigator:||Eske K Aasvang, M.D., DMSci||Rigshospitalet, Denmark|