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

June 29, 2017 updated by: Lauren J. Fisher, Beth Israel Deaconess Medical Center
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
placebo
Drug: placebo
2 ml normal saline IV x1
Active Comparator: Intervention
Dexamethasone 8mg iv x 1
Drug: Dexamethasone 8mg iv x1
Dexamethasone 8mg iv x1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours
Postop Nausea
Time Frame: 24 hours
NRS scale 0-10 for nausea. Zero indicates no nausea, Ten indicates the worst nausea imagined.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Investigators

  • Principal Investigator: Lauren Fisher, DO, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 22, 2010

First Submitted That Met QC Criteria

June 22, 2010

First Posted (Estimate)

June 23, 2010

Study Record Updates

Last Update Posted (Actual)

July 7, 2017

Last Update Submitted That Met QC Criteria

June 29, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009P000345

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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