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Trial record 10 of 551 for:    Celecoxib

Evaluation of Perioperative Celecoxib for Hip Arthroscopy (Celecoxib)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02779166
Recruitment Status : Completed
First Posted : May 20, 2016
Results First Posted : May 14, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Terry, Northwestern University

Tracking Information
First Submitted Date  ICMJE May 13, 2016
First Posted Date  ICMJE May 20, 2016
Results First Submitted Date  ICMJE February 13, 2017
Results First Posted Date  ICMJE May 14, 2019
Last Update Posted Date September 23, 2019
Study Start Date  ICMJE August 2012
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period [ Time Frame: Pre operative on day of surgery, immediately following OR close, 1 hr post operatively, 2 hrs post operatively ]
    The pain VAS is a uni dimensional measure of pain intensity. It is a continuous scale comprised of a 0-10 pain rating. A score of 0 indicates no pain while a score of 10 would indicate extreme pain.
  • Total Narcotic Consumption in the Post Anesthesia Care Unit (PACU) [ Time Frame: duration of PACU stay,immediate post op period up to a maximum of 4 hours postoperatively ]
    Monitored consumption of narcotic medications following surgery, measured in morphine equivalents
  • Time to Discharge Following Surgery [ Time Frame: time from OR to discharge, up to a maximum of 6 hours postoperatively ]
    Total time to discharge from OR close following surgery, measured in minutes
Original Primary Outcome Measures  ICMJE
 (submitted: May 19, 2016)
  • Visual analog score [ Time Frame: 2 hours postoperatively ]
    patient reported rating of pain
  • Total narcotic consumption (measured in morphine equivalents) [ Time Frame: duration of PACU stay, up to a maximum of 4 hours postoperatively ]
  • Time to discharge [ Time Frame: time from OR to discharge, up to a maximum of 6 hours postoperatively ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Perioperative Celecoxib for Hip Arthroscopy
Official Title  ICMJE Evaluation of Perioperative Celecoxib for Hip Arthroscopy
Brief Summary Celecoxib is commonly used for perioperative pain control for certain orthopaedic procedures. It has been shown to be successful in assisting in pain control for knee arthroscopy. It has not previously been studied in hip arthroscopy. This is a double blinded randomized controlled trial to determine the efficacy of celecoxib in perioperative pain control for hip arthroscopy.
Detailed Description This study examines the efficacy of perioperative dose of celecoxib in pain management after hip arthroscopy. Perioperative administration of celecoxib has been shown to improve pain control after knee arthroscopy, but this has not yet been studied in the hip. In this study, patients are randomized to receive either 400mg celecoxib or placebo 1 hour prior to undergoing hip arthroscopy surgery. Postoperatively, patients are monitored for pain on the VAS scale, narcotic use, and meeting discharge criteria. The study will enroll 100 patients. Patients are approached for informed consent on the day of surgery. Pain scores, narcotic use, and time to discharge in the celecoxib group are compared to the placebo group.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Hip Labral Tears
Intervention  ICMJE
  • Drug: Celecoxib
    Received 400mg celecoxib prior to surgery
  • Drug: placebo
Study Arms  ICMJE
  • Experimental: Intervention
    Received 400mg celecoxib prior to surgery
    Intervention: Drug: Celecoxib
  • Placebo Comparator: Placebo
    Received placebo pill prior to surgery
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2019)
98
Original Actual Enrollment  ICMJE
 (submitted: May 19, 2016)
96
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients who are undergoing a hip arthroscopy procedure at Northwestern Memorial Hospital with Dr. Michael Terry.

Exclusion Criteria:

  • Pregnant women and any patient under the age of 18 years.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02779166
Other Study ID Numbers  ICMJE STU00067550
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Terry, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Terry, MD Northwestern University
PRS Account Northwestern University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP