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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Post Operative Pain Nausea Drug: Dexamethasone 8mg iv x1 Drug: placebo Phase 4

Detailed Description:
Findings of Modest improvement in pain scores and postoperative nausea at 24 hours with Dexamethasone

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery
Study Start Date : December 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention
Dexamethasone 8mg iv x 1
Drug: Dexamethasone 8mg iv x1
Dexamethasone 8mg iv x1

Placebo Comparator: Placebo
placebo
Drug: placebo
2 ml normal saline IV x1




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Postop Nausea [ Time Frame: 24 hours ]
    NRS scale 0-10 for nausea. Zero indicates no nausea, Ten indicates the worst nausea imagined.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149616


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Lauren Fisher, DO Beth Israel Deaconess Medical Center
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Responsible Party: Lauren J. Fisher, Attending Physician, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01149616    
Other Study ID Numbers: 2009P000345
First Posted: June 23, 2010    Key Record Dates
Results First Posted: July 7, 2017
Last Update Posted: July 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents