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

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ClinicalTrials.gov Identifier: NCT01149616
Recruitment Status : Terminated (investigators changed jobs, no longer affiliated with institution)
First Posted : June 23, 2010
Results First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Lauren J. Fisher, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date  ICMJE June 22, 2010
First Posted Date  ICMJE June 23, 2010
Results First Submitted Date  ICMJE March 1, 2017
Results First Posted Date  ICMJE July 7, 2017
Last Update Posted Date July 7, 2017
Study Start Date  ICMJE December 2009
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2017)
Post Operative VAS Pain Scale [ Time Frame: 24 hours ]
Patients were instructed to select a number between zero and ten to indicate the degree of pain they experience (zero being no pain and ten being the worst pain they could imagine). Therefore, ten is worse than zero.
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2010)
Post operative VAS Pain scale [ Time Frame: 24 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2017)
  • Amount of Postop Narcotic Usage [ Time Frame: 24 hours ]
    Patients were requested to record the number of prescribed oral analgesic (oxycodone 5 mg/aceteminophen 325 mg) tablets taken for the first 24 hours following discharge
  • Postop Nausea [ Time Frame: 24 hours ]
    NRS scale 0-10 for nausea. Zero indicates no nausea, Ten indicates the worst nausea imagined.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2010)
  • Amount of post operative narcotic use [ Time Frame: 24 hours ]
  • Post operative nausea and vomiting [ Time Frame: 24 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery
Official Title  ICMJE Effects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery
Brief Summary 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 VAS (Visual Analog Scale) for Pain the investigators can show that a single dose of dexamethasone can reduce pain scales and opiate consumption post-operatively, on Post Operative Day (POD 1) when compared to placebo.
Detailed Description Findings of Modest improvement in pain scores and postoperative nausea at 24 hours with Dexamethasone
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Post Operative Pain
  • Nausea
Intervention  ICMJE
  • Drug: Dexamethasone 8mg iv x1
    Dexamethasone 8mg iv x1
  • Drug: placebo
    2 ml normal saline IV x1
Study Arms  ICMJE
  • Active Comparator: Intervention
    Dexamethasone 8mg iv x 1
    Intervention: Drug: Dexamethasone 8mg iv x1
  • Placebo Comparator: Placebo
    placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 22, 2010)
82
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01149616
Other Study ID Numbers  ICMJE 2009P000345
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Lauren J. Fisher, Beth Israel Deaconess Medical Center
Original Responsible Party Lauren Fisher, BIDMC
Current Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lauren Fisher, DO Beth Israel Deaconess Medical Center
PRS Account Beth Israel Deaconess Medical Center
Verification Date June 2017

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