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Completed

NCT Number: NCT02134496

PACU Discharge Without Motorfunction Assessment After Spinal Anaesthesia

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.

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Key information

Conditions

Osteoarthritis Susceptibility 3

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gentofte Hospital, Gentofte Municipality, International, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

assessment of motorfunction in PACU

Procedure

assessment of motorfunction in PACU after spinal anesthesia

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. Time to discharge from PACU

    Time frame: 12 hours

    Time from arrival to discharge i PACU measured in minuttes

  2. 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

  3. Failed spinal anesthesia.

    Time frame: 6 hours.

    Incidence and related factors to failed spinal anesthesia (ie. conversion to generel anesthesia)

  4. Prediction of PACU complications

    Time frame: 0-7 hours

    Factors related to, and incidence of, moderate/severe complications i PACU

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

PACU Discharge Without Motorfunction Assessment After Spinal Anaesthesia for Total Hip or Knee Arthroplasty - a Multicenter Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 9, 2014
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.