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Evaluation of Perioperative Celecoxib for Hip Arthroscopy (Celecoxib)

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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

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.

Condition or disease Intervention/treatment Phase
Hip Labral Tears Drug: Celecoxib Drug: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Perioperative Celecoxib for Hip Arthroscopy
Study Start Date : August 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arm Intervention/treatment
Experimental: Intervention
Received 400mg celecoxib prior to surgery
Drug: Celecoxib
Received 400mg celecoxib prior to surgery

Placebo Comparator: Placebo
Received placebo pill prior to surgery
Drug: placebo



Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779166


Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Michael Terry, MD Northwestern University

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Responsible Party: Michael Terry, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02779166     History of Changes
Other Study ID Numbers: STU00067550
First Posted: May 20, 2016    Key Record Dates
Results First Posted: May 14, 2019
Last Update Posted: September 23, 2019
Last Verified: September 2019
Keywords provided by Michael Terry, Northwestern University:
hip arthroscopy
Additional relevant MeSH terms:
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Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action