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

NCT01149616 | Terminated Phase 4 Results

• 1 other identifier: 2009P000345
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain; Nausea

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Secondary Outcomes (2)

• Amount of Postop Narcotic Usage

  24 hours

• Postop Nausea

  24 hours

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Dexamethasone 8mg iv x 1

Drug: Dexamethasone 8mg iv x1

Placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

Dexamethasone 8mg iv x1 DRUG

Dexamethasone 8mg iv x1

Intervention

placebo DRUG

2 ml normal saline IV x1

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing ambulatory knee arthroscopy surgery
• Must provide phone contact number and agree to phone followup on post operative day 1

You may not qualify if:

• Patients with major systemic disease
• Allergy or intolerance to study drug

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Nausea

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr Lauren Fisher
• Organization: Beth Israel Deaconess Medical Center

lauren_fisher@dmgaz.org

6176671853

Study Officials

• Lauren Fisher, DO

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: June 23, 2010
• Study Start: December 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 7, 2017
• Results First Posted: July 7, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)