Comparing pain relief methods after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.