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

• ClinicalTrials.gov Identifier: NCT01149616
• Recruitment Status: Terminated
• First Posted: June 23, 2010
• Results First Posted: July 7, 2017
• Last Update Posted: July 7, 2017
• Sponsor: Beth Israel Deaconess Medical Center
• Information provided by (Responsible Party): Lauren J. Fisher, Beth Israel Deaconess Medical Center

Tracking Information

• First Submitted Date: June 22, 2010
• First Posted Date: June 23, 2010
• Results First Submitted Date: March 1, 2017
• Results First Posted Date: July 7, 2017
• Last Update Posted Date: July 7, 2017
• Study Start Date: December 2009
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 29, 2017)

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.

• Original Primary Outcome Measures (submitted: June 22, 2010): Post operative VAS Pain scale [ Time Frame: 24 hours ]

Current Secondary Outcome Measures (submitted: June 29, 2017)

• 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
• Postop Nausea [ Time Frame: 24 hours ]
  NRS scale 0-10 for nausea. Zero indicates no nausea, Ten indicates the worst nausea imagined.

Original Secondary Outcome Measures (submitted: June 22, 2010)

• Amount of post operative narcotic use [ Time Frame: 24 hours ]
• Post operative nausea and vomiting [ Time Frame: 24 hours ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Post Operative Pain
• Nausea

Intervention

• Drug: Dexamethasone 8mg iv x1
  Dexamethasone 8mg iv x1
• Drug: placebo
  2 ml normal saline IV x1

Study Arms

• Active Comparator: Intervention
  Dexamethasone 8mg iv x 1
  Intervention: Drug: Dexamethasone 8mg iv x1
• Placebo Comparator: Placebo
  placebo
  Intervention: Drug: placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: June 22, 2010): 82
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01149616
• Other Study ID Numbers: 2009P000345
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Lauren J. Fisher, Beth Israel Deaconess Medical Center
• Original Responsible Party: Lauren Fisher, BIDMC
• Current Study Sponsor: Beth Israel Deaconess Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Beth Israel Deaconess Medical Center
• Verification Date: June 2017