Hip Arthroscopy
Conditions
Brief summary
This study is being conducted to evaluate the effectiveness of post-operative pain control without using narcotic pain medications.
Interventions
DRUGOxycodone
5 mg tablets every 4 hours postoperatively as needed for pain control
DRUGIbuprofen
800 mg three times a day for 2 weeks postoperatively for pain control; not to exceed 3200 mg/day
DRUGGabapentin
300 mg three times a day for 5 days then wean off by day 10 postoperatively
DRUGAcetaminophen
1000 mg three times a day for up to 4 weeks postoperatively for pain control; not to exceed 4 grams per day
DRUGMethocarbamol
500 mg three times a week for 2 weeks postoperatively
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Scheduled for a primary Hip Arthroscopy at Mayo Clinic (Rochester, MN)
Exclusion criteria
* medical history of known allergies or intolerance to allergies or intolerance to Motrin, Gabapentin, Tylenol, dexamethasone, tramadol, or Robaxin. * Substantial alcohol or drug abuse. * History of narcotics within 6 months of surgery. * Pregnancy. * Renal impairment. * Peptic ulcer disease. * GI bleeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score | 1 day post-operatively, 14 days post-operatively | The change in pain score measured using a visual analog scale (VAS) to rate pain on a scale 0-10; 0=no pain to 10=worst possible pain with higher scores indicating worsening pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score | Baseline; 14 days post operatively | The PROMIS Pain Interference Score is a 6-item patient-reported measure assessing how pain disrupts daily activities. Responses are scored on a 5-point Likert scale (1= Not at all to 5= very much). Each item is scored individually, and the raw scores are summed to produce a total score. The total raw score is then converted to a T-score which standardizes the score with a mean of 50 and a standard deviation of 10 based on the general population. Higher T-scores indicate greater interference. |
| Change in Opioid Consumption | Day 1 Post-Operatively; Day 14 Post-Operatively | The change in opioid consumption from day 1 post-operative to day 14 post-operative in the opioid arm expressed in morphine milligram equivalents (MME). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKelechi Okoroha, MD
Mayo Clinic
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 32.6 years STANDARD_DEVIATION 11.3 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 43 participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 43 |
| other Total, other adverse events | 33 / 43 | 33 / 43 |
| serious Total, serious adverse events | 0 / 43 | 0 / 43 |
Outcome results
None listed