Hip Labral Tears
Conditions
Keywords
hip arthroscopy
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.
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.
Interventions
DRUGCelecoxib
Received 400mg celecoxib prior to surgery
DRUGplacebo
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period | 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) | 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 from OR to discharge, up to a maximum of 6 hours postoperatively | Total time to discharge from OR close following surgery, measured in minutes |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Received 400mg celecoxib prior to surgery
Celecoxib: Received 400mg celecoxib prior to surgery | 50 |
| Placebo Received placebo pill prior to surgery
placebo | 48 |
| Total | 98 |
Baseline characteristics
| Characteristic | Total | Intervention | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 98 Participants | 50 Participants | 48 Participants |
| Age, Continuous | 35.0 years STANDARD_DEVIATION 11.7 | 34.2 years STANDARD_DEVIATION 11.9 | 35.8 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment United States | 98 Participants | 50 Participants | 48 Participants |
| Sex: Female, Male Female | 55 Participants | 26 Participants | 29 Participants |
| Sex: Female, Male Male | 43 Participants | 24 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 48 |
| serious Total, serious adverse events | 0 / 50 | 0 / 48 |
Outcome results
Primary
Time to Discharge Following Surgery
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Time to Discharge Following Surgery | 152.9 minutes | Standard Deviation 55.2 |
| Placebo | Time to Discharge Following Surgery | 172.9 minutes | Standard Deviation 57.6 |
Primary
Total Narcotic Consumption in the Post Anesthesia Care Unit (PACU)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Total Narcotic Consumption in the Post Anesthesia Care Unit (PACU) | 15.326 morphine milligram equivalents | Standard Deviation 11 |
| Placebo | Total Narcotic Consumption in the Post Anesthesia Care Unit (PACU) | 15.419 morphine milligram equivalents | Standard Deviation 13.2 |
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.
Time frame: Pre operative on day of surgery, immediately following OR close, 1 hr post operatively, 2 hrs post operatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period | Pre-Operative VAS Score | 2.11 score on a scale | Standard Error 2.06 |
| Intervention | Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period | Immediate Post Op VAS Score | 4.41 score on a scale | Standard Error 3 |
| Intervention | Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period | 1 hr Post Op VAS Score | 4.63 score on a scale | Standard Error 1.91 |
| Intervention | Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period | 2 hr Post Op VAS Score | 4.11 score on a scale | Standard Error 1.75 |
| Placebo | Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period | 2 hr Post Op VAS Score | 4.92 score on a scale | Standard Error 1.98 |
| Placebo | Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period | Pre-Operative VAS Score | 2.33 score on a scale | Standard Error 1.98 |
| Placebo | Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period | 1 hr Post Op VAS Score | 5.36 score on a scale | Standard Error 1.92 |
| Placebo | Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period | Immediate Post Op VAS Score | 5.02 score on a scale | Standard Error 3.1 |