Hip Labral TearsCelecoxibNCT02779166
Evaluation of Perioperative Celecoxib for Hip Arthroscopy
A study testing Celecoxib in people with Hip Labral Tears, run by Northwestern University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hip Labral Tears
- What is being tested?
- Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who are undergoing a hip arthroscopy procedure at Northwestern Memorial Hospital with Dr. Michael Terry.
Who cannot join
- Pregnant women and any patient under the age of 18 years.
About this study
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.
Read the 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.
- Conditions
- Hip Labral Tears
- Being tested
- Celecoxib, placebo
- Keywords
- hip arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Received 400mg celecoxib prior to surgery
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Received 400mg celecoxib prior to surgery Receives: Drug: Celecoxib |
| Placebo | Placebo comparator | Received placebo pill prior to surgery Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: time from OR to discharge, up to a maximum of 6 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startAug 2012
- Primary completionJan 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hip Labral TearsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Terry, Northwestern University
- Investigators
- Michael Terry, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779166
- Sponsor's protocol ID
- STU00067550
- Acronym
- Celecoxib
- Status last verified
- Sep 2019
- First submitted
- 13 May 2016
- Last updated
- 23 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perioperative Celecoxib for Hip Arthroscopy
- ClinicalTrials.gov ID
- NCT02779166
- Acronym / sponsor ID
- Celecoxib / STU00067550
- Conditions
- Hip Labral Tears
- Keywords
- hip arthroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Posted 14 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: CelecoxibReceived 400mg celecoxib prior to surgery |
| Placebo | Placebo comparator | Drug: placeboReceived placebo pill prior to surgery |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who are undergoing a hip arthroscopy procedure at Northwestern Memorial Hospital with Dr. Michael Terry.
Key exclusion criteria (1 listed)
- Pregnant women and any patient under the age of 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelecoxibReceived 400mg celecoxib prior to surgery | Drug | Intervention |
| placebo | Drug | Placebo |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hip Labral Tears
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Hip Arthroscopy Postoperative Opioid Demands
Opioid Use, Pain
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Arthroscopic Treatment of Acetabular Labral Lesions: Intrarticular Injection of Bone Marrow vs Hip Arthroscopy Alone
FemoroAcetabular Impingement
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Blood Flow Restriction Following Hip Arthroscopy
Labral Tear, Glenoid, Femoral Acetabular Impingement
Active, not recruiting
Arthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum
Acetabular Labrum Tear, Femoro Acetabular Impingement
RecruitingObservational study
Use of BMAC With Hip Arthroscopy Treatment of FAI and Labral Tear
Acetabular Labrum Tear, Femoro Acetabular Impingement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Terry, MD principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
A study testing Celecoxib in people with Hip Labral Tears, run by Northwestern University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.