Osteoarthritis Susceptibility 3NCT02134496
PACU Discharge Without Motorfunction Assessment After Spinal Anaesthesia
A study testing assessment of motorfunction in PACU in people with Osteoarthritis Susceptibility 3, run by Copenhagen University Hospital, Rigshospitalet at 5 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Susceptibility 3
- What is being tested?
- assessment of motorfunction in PACU
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,511 participants
- Where
- 5 sitesDenmark
- Study dates
- Jun 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 yr or more
- primary unilateral total hip or knee arthroplasty
- spinal anesthesia
Who cannot join
- intraoperative conversion to general anesthesia
- intraoperative bleeding exceeding 750 ml.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Farsø Sygehus
Farsø, 4640
Gentofte Hospital
Gentofte Municipality, International, 2900
Holstebro Sygehus
Holstebro
Vejle Sygehus
Vejle, International, 7100
Viborg Hospital
Viborg
About this study
Official title: 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 .
Read more
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.
Read the 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.
- Conditions
- Osteoarthritis Susceptibility 3
- Being tested
- assessment of motorfunction in PACU
- Keywords
- hip, knee, arthroplasty, spinal, anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of motorfunction in PACUProcedure or surgery
assessment of motorfunction in PACU after spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| no assessment of motorfunction in PACU | No intervention | no assessment of motorfunction after spinal anesthesia in PACU |
| motorfunction assessment in PACU | Active comparator | Assesment of motorfunction after spinal anesthesia Receives: Procedure: assessment of motorfunction in PACU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
Adverse events
Any event that results in a physicians assessment of the patient, not including regular rounds during the first 24 hours after surgery.
Measured: 24 hours postooperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis Susceptibility 3Studies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eske Kvanner Aasvang, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Henrik Kehlet, Professor, Study chair, Copenhagen University Hospital, RigshospitaletEske K Aasvang, M.D., DMSci, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134496
- Sponsor's protocol ID
- H-1-2014-012
- Status last verified
- Nov 2016
- First submitted
- 28 Apr 2014
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29578248
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PACU Discharge Without Motorfunction Assessment After Spinal Anaesthesia for Total Hip or Knee Arthroplasty - a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02134496
- Acronym / sponsor ID
- H-1-2014-012
- Conditions
- Osteoarthritis Susceptibility 3
- Keywords
- hip, knee, arthroplasty, spinal, anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,511 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no assessment of motorfunction in PACU | No intervention | –no assessment of motorfunction after spinal anesthesia in PACU |
| motorfunction assessment in PACU | Active comparator | Procedure: assessment of motorfunction in PACUAssesment of motorfunction after spinal anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 yr or more
- primary unilateral total hip or knee arthroplasty
- spinal anesthesia
Key exclusion criteria (2 listed)
- intraoperative conversion to general anesthesia
- intraoperative bleeding exceeding 750 ml.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessment of motorfunction in PACUassessment of motorfunction in PACU after spinal anesthesia | Procedure or surgery | motorfunction assessment in PACU |
Primary outcome
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.
1 secondary outcome
Adverse events
Time frame: 24 hours postooperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- Derived from this study: PubMed 29578248Aasvang 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Kehlet, Professor study chair
Copenhagen University Hospital, Rigshospitalet
Eske K Aasvang, M.D., DMSci principal investigator
Copenhagen University Hospital, Rigshospitalet
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assessment of motorfunction in PACU in people with Osteoarthritis Susceptibility 3, run by Copenhagen University Hospital, Rigshospitalet at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lenght of stay (in days) or 30 day readmissions (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02134496, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016.