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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Received 400mg celecoxib prior to surgery |
|
| Placebo | Placebo Comparator | Received placebo pill prior to surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | Received 400mg celecoxib prior to surgery |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Terry, MD | Northwestern University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | 50 patients received 400mg celecoxib prior to surgery Celecoxib: Received 400mg celecoxib prior to surgery |
| FG001 | Placebo | 48 received placebo pill prior to surgery placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Received 400mg celecoxib prior to surgery Celecoxib: Received 400mg celecoxib prior to surgery |
| BG001 | Placebo | Received placebo pill prior to surgery placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | score on a scale | Pre operative on day of surgery, immediately following OR close, 1 hr post operatively, 2 hrs post operatively |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | 50 patients received 400mg celecoxib prior to surgery Celecoxib: Received 400mg celecoxib prior to surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Terry | Northwestern Univeristy Department of Orthopaedic Surgery | 312-926-4444 |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| placebo |
| Drug |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Total Narcotic Consumption in the Post Anesthesia Care Unit (PACU) | Monitored consumption of narcotic medications following surgery, measured in morphine equivalents | Posted | Mean | Standard Deviation | morphine milligram equivalents | duration of PACU stay,immediate post op period up to a maximum of 4 hours postoperatively |
|
|
|
| Primary | Time to Discharge Following Surgery | Total time to discharge from OR close following surgery, measured in minutes | Posted | Mean | Standard Deviation | minutes | time from OR to discharge, up to a maximum of 6 hours postoperatively |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Placebo | 48 received placebo pill prior to surgery placebo | 0 | 48 | 0 | 48 |
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| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |