PACU Discharge Without Motorfunction Assessment After Spinal Anaesthesia

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis Susceptibility 3
• Intervention / Treatment: Procedure: assessment of motorfunction in PACU

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.

• Study Type: Interventional
• Enrollment (Actual): 1511
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Farsø, Denmark, 4640
    • Farsø Sygehus
  • Holstebro, Denmark
    • Holstebro Sygehus
  • Viborg, Denmark
    • Viborg Hospital
  • International
    • Gentofte, International, Denmark, 2900
      • Gentofte Hospital
    • Vejle, International, Denmark, 7100
      • Vejle Sygehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lenght of stay (in days) or 30 day readmissions	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Any event that results in a physicians assessment of the patient, not including regular rounds during the first 24 hours after surgery.	24 hours postooperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to discharge from PACU	Time from arrival to discharge i PACU measured in minuttes	12 hours
Discharge readiness before leaving the operating theater	How many patients fulfilled the PACU discahrge criteria at the time they were leaving the operating theater	1 hour
Failed spinal anesthesia.	Incidence and related factors to failed spinal anesthesia (ie. conversion to generel anesthesia)	6 hours.
Prediction of PACU complications	Factors related to, and incidence of, moderate/severe complications i PACU	0-7 hours

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Study Chair: Henrik Kehlet, Professor, Rigshospitalet, Denmark; Principal Investigator: Eske K Aasvang, M.D., DMSci, Rigshospitalet, Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 28, 2014
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (Estimate): May 9, 2014

Study Record Updates

• Last Update Posted (Estimate): November 28, 2016
• Last Update Submitted That Met QC Criteria: November 24, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: anesthesia; knee; arthroplasty; hip; spinal
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Disease Susceptibility
• Other Study ID Numbers: H-1-2014-012