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

Phase 4

Terminated

• Conditions: Post Operative Pain; Nausea
• Interventions: Drug: Dexamethasone 8mg iv x1; Drug: placebo

• Registration Number: NCT01149616
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-06-22
• Study First Submitted QC: 2010-06-22
• Study First Posted: 2010-06-23
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2017-03-01
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-29
• Last Update Submitted: 2017-06-29
• Results First Posted: 2017-07-07
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Dexamethasone 8mg iv x1	Dexamethasone 8mg iv x 1
Placebo	placebo	placebo

Primary Outcome Measures

Name	Time	Method
Post Operative VAS Pain Scale	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

Name	Time	Method
Amount of Postop Narcotic Usage	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	24 hours	NRS scale 0-10 for nausea. Zero indicates no nausea, Ten indicates the worst nausea imagined.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States