Effect of Celecoxib on Transitional Pain After Outpatient Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
First received: April 18, 2008
Last updated: April 22, 2008
Last verified: April 2008
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

Condition Intervention Phase
Drug: celebrex
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Celecoxib on Transitional Pain After Outpatient Surgery

Resource links provided by NLM:

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • visual analogue score for pain [ Time Frame: post-op period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • severity of nausea [ Time Frame: post-op period ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2004
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: celebrex
400 mg celebrex given 1 hour preop and celebrex 200 mg BID postop
Placebo Comparator: 2
Drug: placebo
placebo given preop and BID postop


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00664690

Contact: Ngozi Imasogie, MD 519-646-6000 ext 64219 nimasog@uwo.ca

Canada, Ontario
St. Joseph's Health Care Recruiting
London, Ontario, Canada, N
Principal Investigator: Ngozi Imasogie, MD         
Sponsors and Collaborators
Lawson Health Research Institute
Principal Investigator: Ngozi Imasogie, MD Lawson Health Research Institute
  More Information

Responsible Party: Dr. Ngozi Imasogie, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00664690     History of Changes
Other Study ID Numbers: R-04-309  10457 
Study First Received: April 18, 2008
Last Updated: April 22, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
shoulder surgery

ClinicalTrials.gov processed this record on May 22, 2016