NCT03161938

Brief Summary

The aim of this study is to investigate the effect of a single preoperative high-dose steroid injection on complications in the immediate postoperative phase after periacetabular osteotomy. Primary outcome is the proportion of patients who have moderate to severe postoperative pain in the post anaesthesia care unit. Secondary outcomes are organspecific complications in the post anaesthesia phase, pain and nausea the first 5 days, wound infection and readmissions the first 30 days after surgery. The investigators hypothesize that the frequency of moderate to severe pain and organspecific complications in the post anaesthesia care unit will be lower among patients receiving high dose dexamethasone. The investigators hypothesize, that there will be no difference in wound infections or readmissions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2017

Typical duration for phase_4

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

April 24, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2019

Completed
8 months until next milestone

Results Posted

Study results publicly available

April 29, 2020

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

2.3 years

First QC Date

May 17, 2017

Results QC Date

April 3, 2020

Last Update Submit

April 20, 2020

Conditions

Hip DysplasiaPostoperative Complications

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Moderate to Severe Postoperative Pain

    Moderate to severe pain (NRS \> 3) in the post-anesthesia care unit (PACU)

    12 hours

Secondary Outcomes (10)

  • Lenght of Stay, PACU

    24 hours

  • Lenght of Stay, Hospital

    1 week

  • Pain Scores, PACU

    12 hours

  • Complications

    24 hours

  • Self Reported Postoperative Pain

    postoperative day 0 to 4, once a day

  • +5 more secondary outcomes

Study Arms (2)

Dexamethasone 48 mg

ACTIVE COMPARATOR

Dexamethasone 48 mg pre-operative, single shot injection

Drug: Dexamethasone

Dexamethasone 8 mg

ACTIVE COMPARATOR

Dexamethasone 8 mg pre-operative, single shot injection

Drug: Dexamethasone

Interventions

DexamethasoneDRUG

intravenous

Dexamethasone 48 mgDexamethasone 8 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • planned unilateral periacetabular osteotomy
  • informed signed consent

You may not qualify if:

  • Chronic/ongoing (\<30 days) use of glucocorticoids (except inhalation therapy)
  • ongoing (\<30 days) use of immunosuppressive therapy
  • insulin dependent diabetes
  • pregnancy/breastfeeding
  • allergies toward study medication, or medication in the standard treatment
  • surgery cannot be performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • Steinthorsdottir KJ, Awada HN, Dirks J, Sturup J, Winther NS, Kehlet H, Aasvang EK. Early postoperative recovery after peri-acetabular osteotomy: A double-blind, randomised single-centre trial of 48 vs. 8 mg dexamethasone. Eur J Anaesthesiol. 2021 Mar 1;38(Suppl 1):S41-S49. doi: 10.1097/EJA.0000000000001410.

    PMID: 33399374DERIVED

MeSH Terms

Conditions

Hip DislocationPostoperative Complications

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesHip InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Results Point of Contact

Title
Kristin steinthorsdottir
Organization
Rigshospitalet
kjs@dadlnet.dk
31666112

Study Officials

  • kristin J Steinthorsdottir, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, clinical assistant

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 22, 2017

Study Start

April 24, 2017

Primary Completion

August 20, 2019

Study Completion

August 20, 2019

Last Updated

April 29, 2020

Results First Posted

April 29, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)