PACU Discharge Without Motorfunction Assessment After Spinal Anaesthesia

Osteoarthritis Susceptibility 3 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134496
• Other study ID #: H-1-2014-012
• Status: Completed
• Phase: N/A
• First received: April 28, 2014
• Last updated: November 24, 2016
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1511
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease Susceptibility
• Osteoarthritis
• Osteoarthritis Susceptibility 3

Intervention

Procedure:
• assessment of motorfunction in PACU
assessment of motorfunction in PACU after spinal anesthesia

Locations

Country	Name	City	State
Denmark	Farsø Sygehus	Farsø
Denmark	Gentofte Hospital	Gentofte	International
Denmark	Holstebro Sygehus	Holstebro
Denmark	Vejle Sygehus	Vejle	International
Denmark	Viborg Hospital	Viborg

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to discharge from PACU	Time from arrival to discharge i PACU measured in minuttes	12 hours	No
Other	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	No
Other	Failed spinal anesthesia.	Incidence and related factors to failed spinal anesthesia (ie. conversion to generel anesthesia)	6 hours.	No
Other	Prediction of PACU complications	Factors related to, and incidence of, moderate/severe complications i PACU	0-7 hours	Yes
Primary	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	Yes
Secondary	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	Yes