Dexamethasone for Pain After Shoulder Surgery

June 3, 2013 updated by: University of Aarhus

High Dose Dexamethasone as Pain Treatment After Arthroscopic Shoulder Surgery: A Randomised, Blinded Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Horsens, Denmark, DK-8700
        • Horsens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 8 mg dexamethasone
Drug: Dexamethasone
Singe dose preoperatively in 100 ml saline intravenously
Other Names:
  • Fortecortin
PLACEBO_COMPARATOR: Placebo, saline
Drug: Dexamethasone
Singe dose preoperatively in 100 ml saline intravenously
Other Names:
  • Fortecortin
EXPERIMENTAL: 40 mg dexamethasone
Drug: Dexamethasone
Singe dose preoperatively in 100 ml saline intravenously
Other Names:
  • Fortecortin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain score by numeric rating scale
Time Frame: At 8 hours postoperatively
At 8 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of analgesics
Time Frame: During hospital stay, about 4 hours
Need for supplemental analgesic medication during stay in recovery on the day of operation, until discharge.
During hospital stay, about 4 hours
Pain score by numeric rating scale
Time Frame: At about 8 a.m. on the first postoperative day
On the morning of the first postoperative day, the self-evaluated level of pain as assessed by numeric rating scale.
At about 8 a.m. on the first postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Central Denmark Region
Horsens Hospital
The Danish Rheumatism Association
The Family Hede Nielsens Fund

Investigators

  • Principal Investigator: Karen T Bjørnholdt, MD, Aarhus University, Horsens Hospital
  • Study Chair: Kjeld Søballe, Prof. dr.med., Aarhus University Hospital
  • Study Chair: Lone Nikolajsen, ph.d., MD, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

August 9, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (ESTIMATE)

August 11, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 4, 2013

Last Update Submitted That Met QC Criteria

June 3, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KTB-002
  • 2011-003082-15 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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