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Effects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01149616
First received: June 22, 2010
Last updated: June 22, 2011
Last verified: June 2011
History of Changes

June 22, 2010
June 22, 2011
December 2009
December 2012   (final data collection date for primary outcome measure)
Post operative VAS Pain scale [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01149616 on ClinicalTrials.gov Archive Site
  • Amount of post operative narcotic use [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Post operative nausea and vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery
Effects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery

The purpose of the study is to determine the opiate sparing effects of intravenously administered dexamethasone in outpatient knee surgery. Dexamethasone is a glucocorticoid with well known antiemetic effects. However, the analgesic effects of dexamethasone have not been adequately researched. Following surgery, patients are typically discharged home with PO opiates to manage post-operative pain. The investigators believe that by using Visual Analog scales for Pain the investigators can show that a single dose of dexamethasone can reduce pain scales and opiate consumption post-operatively, on POD 0 and POD 1 when compared to placebo.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Post Operative Pain
  • Nausea and Vomiting
  • Drug: Dexamethasone 8mg iv x1
    Dexamethasone 8mg iv x1
  • Drug: placebo
    placebo administered IV x1
  • Active Comparator: Intervention
    Dexamethasone 8mg iv x 1
    Intervention: Drug: Dexamethasone 8mg iv x1
  • Placebo Comparator: Placebo
    placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
82
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients undergoing ambulatory knee arthroscopy surgery
  • Must provide phone contact number and agree to phone followup on post operative day 1

Exclusion Criteria:

  • Patients with major systemic disease
  • Allergy or intolerance to study drug
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01149616
2009-P-000345/1; BIDMC
No
Lauren Fisher, BIDMC
Beth Israel Deaconess Medical Center
Not Provided
Principal Investigator: Lauren Fisher, DO Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP