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Completed

NCT Number: NCT01414569

Dexamethasone for Pain After Shoulder Surgery

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.

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Key information

Conditions

Shoulder Impingement Syndrome Arthritis Joint Diseases Musculoskeletal Diseases Shoulder Injuries Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Horsens Hospital

Horsens, DK-8700, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Singe dose preoperatively in 100 ml saline intravenously

Other names: Fortecortin

Primary outcomes

  1. Pain score by numeric rating scale

    Time frame: At 8 hours postoperatively

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Central Denmark Region
  • Horsens Hospital
  • The Danish Rheumatism Association
  • The Hede Nielsen Family Foundation

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 11, 2011
Registry last updated
Jun 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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