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
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00664690
First received: April 18, 2008
Last updated: April 22, 2008
Last verified: April 2008
  Purpose

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
Pain
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
celebrex
Drug: celebrex
400 mg celebrex given 1 hour preop and celebrex 200 mg BID postop
Placebo Comparator: 2
placebo
Drug: placebo
placebo given preop and BID postop

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664690

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

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

No publications provided

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
analgesia

Additional relevant MeSH terms:
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 24, 2014