Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial
Overview
- Phase
- Phase 4
- Intervention
- Acetaminophen
- Conditions
- Surgery
- Sponsor
- University of Michigan
- Enrollment
- 900
- Locations
- 15
- Primary Endpoint
- Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 7 days post surgery
- Status
- Recruiting
- Last Updated
- 15 days ago
Overview
Brief 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.
Investigators
Mark Bicket, MD, PhD
Associate Professor
University of Michigan
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.
Arms & Interventions
NSAID regimen
Surgical teams will elect for one of the medications within the treatment arm to which the patient is randomized.
Intervention: Acetaminophen
NSAID regimen
Surgical teams will elect for one of the medications within the treatment arm to which the patient is randomized.
Intervention: NSAID
Opioid regimen
Intervention: Opioid
Opioid regimen
Intervention: Acetaminophen
Outcomes
Primary Outcomes
Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 7 days post surgery
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance v1.0 4a questionnaire(1 month post surgery)
- Patient Global Impression of Change (PGIC)(up to 1 month after surgery)
- Quality of Recovery (QoR) 15(7 days post surgery)
- PROMIS Pain Interference 4a(3 months)
- New prolonged opioid use(days 4-180 post surgery)
- Chronic pain based on Brief Pain Inventory (BPI) pain intensity score at 180 days post surgery(180 days post surgery)
- Chronic pain based on Body Map(180 days post surgery)
- Acute pain based on The Michigan Body Map(7 days post surgery)
- Healthcare Utilization related to pain at 1 month(within 1 months after surgery)
- PROMIS Preference score 29+2 Profile v2.1(3 months)
- Substance use based on the Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) tool(180 days post surgery)
- National Survey on Drug Use and Health Questions (NSDUH) on Opioid Misuse opioid misuse question(180 days)
- Clinically important adverse events(180 days post surgery)
- Healthcare Utilization related to pain at 6 months(within 6 months after surgery)
- Quality of Recovery (QoR) 15(3 days post surgery)
- National Survey on Drug Use and Health Questions (NSDUH) on Opioid Misuse opioid misuse question(3 months)