Official Title: “Effect of Celecoxib on Transitional Pain After Outpatient Surgery”

Sixty adults having shoulder and forearm surgery will receive either placebo or celebrex started preoperatively and continued for 3 days. Rescue medications required as well as pain scores will be assessed using a patient diary to evaluate the effect of celebrex in controlling transitional pain

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: celebrex
  • 400 mg celebrex given 1 hour preop and celebrex 200 mg BID postop
• Drug: placebo
  • placebo given preop and BID postop

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • celebrex
• Placebo Comparator: 2
  • placebo

Primary Measures

• visual analogue score for pain
  • Time Frame: post-op period
    Safety Issue?: No

Secondary Measures

• severity of nausea
  • Time Frame: post-op period
    Safety Issue?: No

Inclusion Criteria:

• Patients scheduled for elective ambulatory surgery of the shoulder
• ASA I - III
• Able to read English
• Male or female

Exclusion Criteria:

• Allergy to local anesthetic, Cox2, sulpha drug, acetaminophen or oxycodone
• Women who are pregnant or lactating and women of childbearing age and not following acceptable contraceptive precautions
• Any major medical or psychiatric problem
• Those with a known history of narcotic dependence, abuse or chronic narcotic intake
• Patients with known history of peptic ulcer or GI bleeding in the past, ulcers, congestive heart failure, angina or previous heart attack, coagulation problems, venous thrombosis, kidney or liver disease or strokes

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Lawson Health Research Institute

Overall Clinical Trial Officials and Contacts

Ngozi Imasogie, MD Principal Investigator Lawson Health Research Institute  

Overall Contact: Ngozi Imasogie, MD 519-646-6000 nimasog@uwo.ca

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00664690

Study ID Number: R-04-309

ClinicalTrials.gov Identifier: NCT00664690

Health Authority: Canada: Ethics Review Committee