NCT01604382

Brief Summary

Patients undergoing elective total knee arthroplasty are randomized to either intrathecal anesthesia, wound infiltration with local anesthetics and standardized postoperative care (NA = neuraxial anesthesia) or general anesthesia, intraoperative glucocorticoids with accelerated postoperative care principles (GA). The study hypothesis is that GA would reduce length-of-hospital stay. Outcome variables are postoperative nausea and vomiting, mobilization rate, pain, requirement of analgesics, and length-of-hospital stay.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
Last Updated

May 23, 2012

Status Verified

May 1, 2012

Enrollment Period

8 months

First QC Date

May 20, 2012

Last Update Submit

May 22, 2012

Conditions

Osteoarthritis

Keywords

Total Knee Arthroplasty (TKA)

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    Length of hospital stay is defined as teh time from end of surgery until the patient is ready to be discharged

    participants will be followed for the duration of hospital stay, an expected average of 3 days").

Secondary Outcomes (1)

  • Post operative pain

    measured the first 48 hrs after surgery

Study Arms (2)

treatment

EXPERIMENTAL

Receives General Anesthesia as described above

Drug: General Anesthesia

Placebo

PLACEBO COMPARATOR

Patients receives neuraxial anesthesia as described above

Drug: Neuraxial anesthesia

Interventions

General AnesthesiaDRUG

General Anesthesia as described above

Also known as: Propofol, Remifentanil
treatment
Neuraxial anesthesiaDRUG

Neuraxial anesthesia as described above

Also known as: Bupivacaine
Placebo

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with osteoarthritis scheduled for TKA at the department of orthopedic surgery, Hässleholm Hospital, Sweden, are eligible for participation in the study.

You may not qualify if:

  • body mass index (BMI) \> 35 m/kg2,
  • prior major knee surgery to the ipsilateral knee,
  • ongoing infection, known immunological deficiency or ASA physical status category \> IV.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University, Hässleholm Hospital

Hässleholm, Skåne County, 381 25, Sweden

Location

Related Publications (2)

  • Macfarlane AJ, Prasad GA, Chan VW, Brull R. Does regional anesthesia improve outcome after total knee arthroplasty? Clin Orthop Relat Res. 2009 Sep;467(9):2379-402. doi: 10.1007/s11999-008-0666-9. Epub 2009 Jan 7.

    PMID: 19130163BACKGROUND

  • Molt M, Harsten A, Toksvig-Larsen S. The effect of tourniquet use on fixation quality in cemented total knee arthroplasty a prospective randomized clinical controlled RSA trial. Knee. 2014 Mar;21(2):396-401. doi: 10.1016/j.knee.2013.10.008. Epub 2013 Oct 24.

    PMID: 24238650DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Anesthesia, GeneralPropofolRemifentanilBupivacaine

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesAniline CompoundsAmines

Study Officials

  • Mads Werner, M.D. PhD

    Multidisciplinary Pain Center, Copenhagen, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of dept Anesthesiol, M.D.

Study Record Dates

First Submitted

May 20, 2012

First Posted

May 23, 2012

Study Start

September 1, 2008

Primary Completion

May 1, 2009

Study Completion

June 1, 2010

Last Updated

May 23, 2012

Record last verified: 2012-05

Locations

SE(1)