Back to resultsEffects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery
Primary Purpose
Post Operative Pain, Nausea
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone 8mg iv x1
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain
Eligibility 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
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention
Placebo
Arm Description
Dexamethasone 8mg iv x 1
placebo
Outcomes
Primary Outcome Measures
Post Operative VAS Pain Scale
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
Amount of Postop Narcotic Usage
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
NRS scale 0-10 for nausea. Zero indicates no nausea, Ten indicates the worst nausea imagined.
Full Information
NCT ID
NCT01149616
First Posted
June 22, 2010
Last Updated
June 29, 2017
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01149616
Brief Title
Effects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery
Official Title
Effects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
investigators changed jobs, no longer affiliated with institution
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Nausea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Dexamethasone 8mg iv x 1
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 8mg iv x1
Intervention Description
Dexamethasone 8mg iv x1
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
2 ml normal saline IV x1
Primary Outcome Measure Information:
Title
Post Operative VAS Pain Scale
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Amount of Postop Narcotic Usage
Description
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
Time Frame
24 hours
Title
Postop Nausea
Description
NRS scale 0-10 for nausea. Zero indicates no nausea, Ten indicates the worst nausea imagined.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Fisher, DO
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery
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