PACU Discharge Without Motorfunction Assessment After Spinal Anaesthesia

November 24, 2016 updated by: Eske Kvanner Aasvang, Rigshospitalet, Denmark

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1511

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
24 hours postooperatively

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to discharge from PACU
Time Frame: 12 hours
Time from arrival to discharge i PACU measured in minuttes
12 hours
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
1 hour
Failed spinal anesthesia.
Time Frame: 6 hours.
Incidence and related factors to failed spinal anesthesia (ie. conversion to generel anesthesia)
6 hours.
Prediction of PACU complications
Time Frame: 0-7 hours
Factors related to, and incidence of, moderate/severe complications i PACU
0-7 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rigshospitalet, Denmark

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Henrik Kehlet, Professor, Rigshospitalet, Denmark
  • Principal Investigator: Eske K Aasvang, M.D., DMSci, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-1-2014-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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