Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

NSAID: Once randomized to this group the surgical team will elect for 1 of the following treatment options to be given: * Ibuprofen 600 milligram (mg) by mouth every six hours as needed for pain (10 doses) * Celecoxib 400 mg by mouth once then 200 mg every twelve hours as needed for pain (10 doses) * Naproxen 500 mg by mouth once then 250 mg by mouth every eight hours as needed for pain (10 doses)

Opioid: Once randomized to this group the surgical team will elect for 1 of the following treatment options to be given: * Oxycodone 5 mg by mouth every four to six hours as needed for pain, 10 doses * Morphine 7.5 mg by mouth every four to six hours as needed for pain, 10 doses * Hydromorphone 2 mg by mouth every four to six hours as needed for pain, 10 doses

Acetaminophen: Acetaminophen 1000 mg by mouth every 6 hours around the clock for the first three days after surgery then as needed thereafter (20 doses).

Study summary

This trial is being completed to compare two commonly used options to treat pain after surgery. Participants that undergo gallbladder removal, hernia repair, and breast lump removal will be eligible to enroll. Eligible participants will be randomized to 1 of 2 groups of medications (Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) plus acetaminophen or low dose opioids plus acetaminophen).

It is anticipated that the NSAID group will have superior clinical outcomes and fewer side effects when compared to the opioid group.

Eligibility

Primary outcome measure(s)

• Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 7 days post surgery — 7 days post surgery
  This is a one question survey in which the worst pain intensity recorded (0-10 being the worst) will be used.
• Safety outcome - number and severity of any adverse medication-related symptoms over 7 days post surgery — 7 days post surgery
  Symptom Checklist will proactively screen patients for reports of adverse events from analgesic medications over the first 7 days post surgery.

Trial sites (8)

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