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Dexamethasone for Pain After Shoulder Surgery

Primary Purpose

Shoulder Impingement Syndrome, Arthritis

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Horsens Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

8 mg dexamethasone

Placebo, saline

40 mg dexamethasone

Arm Description

Outcomes

Primary Outcome Measures

Pain score by numeric rating scale

Secondary Outcome Measures

Use of analgesics
Need for supplemental analgesic medication during stay in recovery on the day of operation, until discharge.
Pain score by numeric rating scale
On the morning of the first postoperative day, the self-evaluated level of pain as assessed by numeric rating scale.

Full Information

First Posted
August 9, 2011
Last Updated
June 3, 2013
Sponsor
University of Aarhus
Collaborators
Horsens Hospital, Central Denmark Region, The Family Hede Nielsens Fund, The Danish Rheumatism Association
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1. Study Identification

Unique Protocol Identification Number
NCT01414569
Brief Title
Dexamethasone for Pain After Shoulder Surgery
Official Title
High Dose Dexamethasone as Pain Treatment After Arthroscopic Shoulder Surgery: A Randomised, Blinded Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Horsens Hospital, Central Denmark Region, The Family Hede Nielsens Fund, The Danish Rheumatism Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome, Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
8 mg dexamethasone
Arm Type
Active Comparator
Arm Title
Placebo, saline
Arm Type
Placebo Comparator
Arm Title
40 mg dexamethasone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Fortecortin
Intervention Description
Singe dose preoperatively in 100 ml saline intravenously
Primary Outcome Measure Information:
Title
Pain score by numeric rating scale
Time Frame
At 8 hours postoperatively
Secondary Outcome Measure Information:
Title
Use of analgesics
Description
Need for supplemental analgesic medication during stay in recovery on the day of operation, until discharge.
Time Frame
During hospital stay, about 4 hours
Title
Pain score by numeric rating scale
Description
On the morning of the first postoperative day, the self-evaluated level of pain as assessed by numeric rating scale.
Time Frame
At about 8 a.m. on the first postoperative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen T Bjørnholdt, MD
Organizational Affiliation
Aarhus University, Horsens Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kjeld Søballe, Prof. dr.med.
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lone Nikolajsen, ph.d., MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Horsens Hospital
City
Horsens
ZIP/Postal Code
DK-8700
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
24825530
Citation
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.
Results Reference
derived

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Dexamethasone for Pain After Shoulder Surgery

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