Arthroscopy
Conditions
Keywords
Knee Surgery, Arthroscopic Surgery
Brief summary
To compare the total analgesic use at 24 hours after arthroscopic knee surgery in patients treated with celecoxib versus placebo.
Interventions
DRUGCelecoxib
400 mg oral capsule as a single dose 1 hour prior to surgery and 200 mg oral capsule as a single dose as needed post-surgery
OTHERPlacebo
Matched placebo
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed knee meniscus pathology requiring ambulatory arthroscopic meniscectomy or partial meniscectomy * Willing to participate in study for 36 hours and come to follow-up visit 7 days post-surgery
Exclusion criteria
* Osteoarthritis, inflammatory arthritis, or previous fracture of index joint * Received acetaminophen or low-dose narcotic within 8 hours of surgery * Have received oral (4 weeks), intramuscular (2 months), intra-articular (3 months) or soft-tissue (2 months) injections of corticosteroids of the first dose of study medication or received intra-articular injections of hyaluronic acid in the index joint within 9 months of the first dose of study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total analgesic use after surgery | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Number and percentage of subjects taking analgesic (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery | 1, 2, 6, 8, 10, 12, 24, and 36 hours |
| Time to analgesic use after surgery | 1, 2, 6, 8, 10, 12, 24, and 36 hours |
| Cumulative number of HC/APAP tablets taken after first dose of study medication | 1, 2, 6, 8, 10, 12, 36 hours and Day 2 |
| Vital signs | Day 7 |
| Physical examination | Day 7 |
| Change in volumetric measurement of both knees from prior to surgery | Day 7 |
| Patient Treatment Satisfaction Scales after surgery | 24 hours |
| Adverse events | Day 7 |
| Patient's Assessment of Knee Pain, according to visual analogue scale at rest and with movement after surgery | 1, 2, 6, 8, 10, 12, 24 and 36 hours |
Countries
United States
Outcome results
None listed