Effect of Celecoxib Versus Placebo Before and After Knee Surgery on the Overall Use of Analgesics After Surgery

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.200 enrolled

Overview

To compare the total analgesic use at 24 hours after arthroscopic knee surgery in patients treated with celecoxib versus placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

200

Conditions

Arthroscopy

Interventions

CelecoxibDRUG

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

PlaceboOTHER

Matched placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (9)

Pfizer Investigational Site

Phoenix, Arizona, United States

Pfizer Investigational Site

St. Petersburg, Florida, United States

Pfizer Investigational Site

Baltimore, Maryland, United States

Pfizer Investigational Site

Outcomes

Primary Outcomes

Total analgesic use after surgery

Time frame: 24 hours

Secondary Outcomes

Physical examination

Time frame: Day 7

Number and percentage of subjects taking analgesic (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery

Time frame: 1, 2, 6, 8, 10, 12, 24, and 36 hours

Time to analgesic use after surgery

Time frame: 1, 2, 6, 8, 10, 12, 24, and 36 hours

Cumulative number of HC/APAP tablets taken after first dose of study medication

Time frame: 1, 2, 6, 8, 10, 12, 36 hours and Day 2

Vital signs

Time frame: Day 7

Patient's Assessment of Knee Pain, according to visual analogue scale at rest and with movement after surgery

Time frame: 1, 2, 6, 8, 10, 12, 24 and 36 hours

Change in volumetric measurement of both knees from prior to surgery

Time frame: Day 7

Patient Treatment Satisfaction Scales after surgery

Time frame: 24 hours

Adverse events

Time frame: Day 7

Data from ClinicalTrials.gov

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