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

Launched by UNIVERSITY OF MICHIGAN · Feb 9, 2023

Keywords

ClinConnect Summary

The CARES Trial is a study designed to compare the effectiveness and safety of two different pain relief methods for patients recovering from surgery. If you're having a gallbladder removal, hernia repair, or breast lump removal, you may be eligible to participate. The trial will assign participants to one of two groups: one group will receive a combination of non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen, while the other group will receive a low dose of opioids (stronger pain relievers) along with acetaminophen. Researchers hope to find that the group taking NSAIDs experiences better pain relief and fewer side effects than those taking opioids.

To qualify for the trial, participants should not have used significant pain medications in the month before their surgery, and they must be undergoing one of the three specified surgical procedures. If you decide to participate, you can expect close monitoring of your pain levels and any side effects from the medications. This trial is important because it aims to find safer and more effective ways to manage pain after surgery, which can help improve recovery for many patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • No significant analgesic medication use before surgery: For this study, significant analgesic medication use before surgery as use of prescriptions for opioid or NSAID medications in the past 30 days, or over-the-counter NSAID use on greater than 7 of 30 past days, as reported by the patient.
• • One of three common low-risk surgical procedures: For this study, the three-common low-risk surgical procedures will include laparoscopic gallbladder removal, inguinal hernia repair, and breast lumpectomy.
• Exclusion Criteria:
• • Anticipated other surgery within 6 months or anticipated life expectancy of less than 6 months
• • Patients with contraindications to NSAID drugs in the NSAID arm, opioid drugs in the OPIOID arm, or acetaminophen will be excluded. There are specific contraindications that will be reviewed per protocol.