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

NCT ID: NCT01149616

Last Updated: 2017-07-07

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-12-31

Brief Summary

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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

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

Conditions

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Post Operative Pain Nausea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

Dexamethasone 8mg iv x 1

Group Type ACTIVE_COMPARATOR

Dexamethasone 8mg iv x1

Intervention Type DRUG

Dexamethasone 8mg iv x1

Placebo

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

2 ml normal saline IV x1

Interventions

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Dexamethasone 8mg iv x1

Dexamethasone 8mg iv x1

Intervention Type DRUG

placebo

2 ml normal saline IV x1

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Lauren J. Fisher

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lauren Fisher, DO

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2009P000345

Identifier Type: -

Identifier Source: org_study_id

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