Evaluation of Perioperative Celecoxib for Hip Arthroscopy (Celecoxib)

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.

Study Overview

• Status: Completed
• Conditions: Hip Labral Tears
• Intervention / Treatment: Drug: placebo; Drug: Celecoxib

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: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period	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.	Pre operative on day of surgery, immediately following OR close, 1 hr post operatively, 2 hrs post operatively
Total Narcotic Consumption in the Post Anesthesia Care Unit (PACU)	Monitored consumption of narcotic medications following surgery, measured in morphine equivalents	duration of PACU stay,immediate post op period up to a maximum of 4 hours postoperatively
Time to Discharge Following Surgery	Total time to discharge from OR close following surgery, measured in minutes	time from OR to discharge, up to a maximum of 6 hours postoperatively

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Michael Terry, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: May 13, 2016
• First Submitted That Met QC Criteria: May 19, 2016
• First Posted (Estimate): May 20, 2016

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: hip arthroscopy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: STU00067550