RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-02-06
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05722002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  1. * Anticipated other surgery within 6 months or anticipated life expectancy of less than 6 months
  2. * 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.

Contacts and Locations

Study Contact

Sarah Clark, BA
CONTACT
734-232-0324
sarahmcl@med.umich.edu

Principal Investigator

Mark Bicket, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Washington University in Saint Louis
Saint Louis, Missouri, 63130
United States
Temple University - Temple Health
Philadelphia, Pennsylvania, 19140
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Mark Bicket, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-06
Study Completion Date2025-10

Study Record Updates

Study Start Date2023-02-06
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

  • Medications after surgery
  • NSAIDS
  • Acetaminophen
  • Opioids
  • laparoscopic gallbladder removal
  • inguinal hernia repair
  • breast lumpectomy
  • Analgesics, non-narcotic

Additional Relevant MeSH Terms

  • Surgery
  • Pain, Postoperative