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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Hip Labral Tears
Interventions Drug: Celecoxib
Drug: placebo
Enrollment 98
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Placebo
Hide Arm/Group Description

50 patients received 400mg celecoxib prior to surgery

Celecoxib: Received 400mg celecoxib prior to surgery

48 received placebo pill prior to surgery

placebo

Period Title: Overall Study
Started 50 48
Completed 50 48
Not Completed 0 0
Arm/Group Title Intervention Placebo Total
Hide Arm/Group Description

Received 400mg celecoxib prior to surgery

Celecoxib: Received 400mg celecoxib prior to surgery

Received placebo pill prior to surgery

placebo

Total of all reporting groups
Overall Number of Baseline Participants 50 48 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 98 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
50
 100.0%
48
 100.0%
98
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 48 participants 98 participants
34.2  (11.9) 35.8  (11.6) 35.0  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 98 participants
Female
26
  52.0%
29
  60.4%
55
  56.1%
Male
24
  48.0%
19
  39.6%
43
  43.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 50 participants 48 participants 98 participants
50
 100.0%
48
 100.0%
98
 100.0%
1.Primary Outcome
Title Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period
Hide Description 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.
Time Frame Pre operative on day of surgery, immediately following OR close, 1 hr post operatively, 2 hrs post operatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Placebo
Hide Arm/Group Description:

50 patients received 400mg celecoxib prior to surgery

Celecoxib: Received 400mg celecoxib prior to surgery

48 received placebo pill prior to surgery

placebo

Overall Number of Participants Analyzed 50 48
Mean (Standard Error)
Unit of Measure: score on a scale
Pre-Operative VAS Score 2.11  (2.06) 2.33  (1.98)
Immediate Post Op VAS Score 4.41  (3.00) 5.02  (3.10)
1 hr Post Op VAS Score 4.63  (1.91) 5.36  (1.92)
2 hr Post Op VAS Score 4.11  (1.75) 4.92  (1.98)
2.Primary Outcome
Title Total Narcotic Consumption in the Post Anesthesia Care Unit (PACU)
Hide Description Monitored consumption of narcotic medications following surgery, measured in morphine equivalents
Time Frame duration of PACU stay,immediate post op period up to a maximum of 4 hours postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Placebo
Hide Arm/Group Description:

50 patients received 400mg celecoxib prior to surgery

Celecoxib: Received 400mg celecoxib prior to surgery

48 received placebo pill prior to surgery

placebo

Overall Number of Participants Analyzed 50 48
Mean (Standard Deviation)
Unit of Measure: morphine milligram equivalents
15.326  (11.0) 15.419  (13.2)
3.Primary Outcome
Title Time to Discharge Following Surgery
Hide Description Total time to discharge from OR close following surgery, measured in minutes
Time Frame time from OR to discharge, up to a maximum of 6 hours postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Placebo
Hide Arm/Group Description:

50 patients received 400mg celecoxib prior to surgery

Celecoxib: Received 400mg celecoxib prior to surgery

48 received placebo pill prior to surgery

placebo

Overall Number of Participants Analyzed 50 48
Mean (Standard Deviation)
Unit of Measure: minutes
152.9  (55.2) 172.9  (57.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Placebo
Hide Arm/Group Description

50 patients received 400mg celecoxib prior to surgery

Celecoxib: Received 400mg celecoxib prior to surgery

48 received placebo pill prior to surgery

placebo

All-Cause Mortality
Intervention Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/48 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/48 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael Terry
Organization: Northwestern Univeristy Department of Orthopaedic Surgery
Phone: 312-926-4444
Layout table for additonal information
Responsible Party: Michael Terry, Northwestern University
ClinicalTrials.gov Identifier: NCT02779166     History of Changes
Other Study ID Numbers: STU00067550
First Submitted: May 13, 2016
First Posted: May 20, 2016
Results First Submitted: February 13, 2017
Results First Posted: May 14, 2019
Last Update Posted: September 23, 2019