Comparing pain relief methods after surgery
Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial
This study is testing whether a combination of over-the-counter pain relievers works better and has fewer side effects than low-dose opioids for people recovering from common surgeries.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 8 sites (Ann Arbor, Michigan and 7 other locations) |
| Trial ID | NCT05722002 on ClinicalTrials.gov |
What this trial studies
This trial compares the effectiveness and safety of two pain management regimens for patients undergoing common low-risk surgical procedures, including laparoscopic gallbladder removal, hernia repair, and breast lump removal. Participants will be randomly assigned to receive either a combination of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and acetaminophen or a low dose of opioids plus acetaminophen. The study aims to determine if the NSAID regimen leads to better clinical outcomes and fewer side effects compared to the opioid regimen.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing laparoscopic gallbladder removal, inguinal hernia repair, or breast lumpectomy with no significant analgesic medication use prior to surgery.
Not a fit: Patients with contraindications to NSAIDs or opioids, or those anticipating other surgeries within six months, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective pain management option for patients after surgery.
How similar studies have performed: Other studies have shown promising results in comparing NSAIDs and opioids for postoperative pain management, indicating this approach has been tested with some success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ann Arbor, Michigan and 7 other locations
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Henry Ford Health System — Detroit, Michigan, United States (Recruiting)
- Washington University in Saint Louis — St Louis, Missouri, United States (Recruiting)
- Cooper University Health Care — Camden, New Jersey, United States (Recruiting)
- University of North Carolina Hospitals — Chapel Hill, North Carolina, United States (Recruiting)
- Temple University - Temple Health — Philadelphia, Pennsylvania, United States (Recruiting)
- Women's College Hospital — Toronto, Ontario, Canada (Recruiting)
- Unity Health Toronto — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Mark Bicket, MD, PhD — University of Michigan
- Study coordinator: Sarah Clark, BA
- Email: sarahmcl@med.umich.edu
- Phone: 734-232-0324
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.