Effect of Celecoxib on Transitional Pain After Outpatient Surgery

August 25, 2017 updated by: Lawson Health Research Institute
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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N
        • St. Joseph's Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
placebo
Drug: placebo
placebo given preop and BID postop
Experimental: 1
celebrex
Drug: celebrex
400 mg celebrex given 1 hour preop and celebrex 200 mg BID postop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
visual analogue score for pain
Time Frame: post-op period
post-op period

Secondary Outcome Measures

Outcome Measure
Time Frame
severity of nausea
Time Frame: post-op period
post-op period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 18, 2008

First Submitted That Met QC Criteria

April 22, 2008

First Posted (Estimate)

April 23, 2008

Study Record Updates

Last Update Posted (Actual)

August 28, 2017

Last Update Submitted That Met QC Criteria

August 25, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-04-309
  • 10457 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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