Dexamethasone for Pain After Shoulder Surgery

NCT ID: NCT01414569

Last Updated: 2013-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-06-30

Brief Summary

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The purpose of this study is to determine if a dose of 40 mg dexamethasone is more effective as pain treatment than the currently used dose of 8 mg after arthroscopic shoulder surgery.

Detailed Description

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Conditions

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Shoulder Impingement Syndrome Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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8 mg dexamethasone

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Singe dose preoperatively in 100 ml saline intravenously

Placebo, saline

Group Type PLACEBO_COMPARATOR

Dexamethasone

Intervention Type DRUG

Singe dose preoperatively in 100 ml saline intravenously

40 mg dexamethasone

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Singe dose preoperatively in 100 ml saline intravenously

Interventions

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Dexamethasone

Singe dose preoperatively in 100 ml saline intravenously

Intervention Type DRUG

Other Intervention Names

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Fortecortin

Eligibility Criteria

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Inclusion Criteria

* Arthroscopic subacromial decompression and/or acromioclavicular resection
* General anaesthesia
* Daysurgery, Horsens Hospital

Exclusion Criteria

* Incompetent
* Pregnant
* Age under 18 or over 90 years
* Allergy toward dexamethasone
* Diabetes
* Active gastric ulcer
* Untreated hypertension
* Glaucoma
* Daily use of glucocorticoids or strong opioids
* Daily use of analgesics for unrelated illness
* Myasthenia gravis
* Mitochondrial disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Horsens Hospital

OTHER

Sponsor Role collaborator

Central Denmark Region

OTHER

Sponsor Role collaborator

The Hede Nielsen Family Foundation

OTHER

Sponsor Role collaborator

The Danish Rheumatism Association

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen T Bjørnholdt, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University, Horsens Hospital

Kjeld Søballe, Prof. dr.med.

Role: STUDY_CHAIR

Aarhus University Hospital

Lone Nikolajsen, ph.d., MD

Role: STUDY_CHAIR

Aarhus University Hospital

Locations

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Horsens Hospital

Horsens, , Denmark

Site Status

Countries

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Denmark

References

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Bjornholdt KT, Monsted PN, Soballe K, Nikolajsen L. Dexamethasone for pain after outpatient shoulder surgery: a randomised, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2014 Jul;58(6):751-8. doi: 10.1111/aas.12333. Epub 2014 May 13.

Reference Type DERIVED
PMID: 24825530 (View on PubMed)

Other Identifiers

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2011-003082-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

KTB-002

Identifier Type: -

Identifier Source: org_study_id

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