Effect of Celecoxib on Transitional Pain After Outpatient Surgery

NCT ID: NCT00664690

Last Updated: 2017-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

celebrex

Group Type EXPERIMENTAL

celebrex

Intervention Type DRUG

400 mg celebrex given 1 hour preop and celebrex 200 mg BID postop

2

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo given preop and BID postop

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

celebrex

400 mg celebrex given 1 hour preop and celebrex 200 mg BID postop

Intervention Type DRUG

placebo

placebo given preop and BID postop

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ngozi Imasogie, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St. Joseph's Health Care

London, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10457

Identifier Type: -

Identifier Source: secondary_id

R-04-309

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Celecoxib for ENT Pain Management
NCT06505187 RECRUITING PHASE2