Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial
- Conditions
- SurgeryPain, Postoperative
- Interventions
- Registration Number
- NCT05722002
- Lead Sponsor
- University of Michigan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 900
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NSAID regimen NSAID Surgical teams will elect for one of the medications within the treatment arm to which the patient is randomized. Opioid regimen Opioid - NSAID regimen Acetaminophen Surgical teams will elect for one of the medications within the treatment arm to which the patient is randomized. Opioid regimen Acetaminophen -
- Primary Outcome Measures
Name Time Method Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 7 days post surgery 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 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 Outcome Measures
Name Time Method Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance v1.0 4a questionnaire 1 month post surgery This is a 4 question survey in which participants will rate statements pertaining to quality of sleep.
Participants will also rate sleep quality as very poor (5), poor (4), fair (3), good (2), or very good (1).Patient Global Impression of Change (PGIC) up to 1 month after surgery The perception of improvement after treatment will be assessed by the patient global impression of change PGIC (range 0-7).
Quality of Recovery (QoR) 15 7 days post surgery There are 15 questions assessed on a scale of 1-10, with 0 being none of the time and 10 being all of the time, 10 being the better outcome.
PROMIS Pain Interference 4a 3 months This is a 4 question survey that assesses the degree to which pain interferes with various aspects of life. Items are scored on a 1 ("Not at all") to 5 ("Very much") scale with a range of 4 - 20. Higher scores indicate greater pain interference.
New prolonged opioid use days 4-180 post surgery This will include greater or equal to 1 opioid prescription post-discharge between 4-180 days post discharge.
Chronic pain based on Brief Pain Inventory (BPI) pain intensity score at 180 days post surgery 180 days post surgery One question survey in which the participants rate pain intensity recorded (0-10), ten being the worst.
Chronic pain based on Body Map 180 days post surgery Participants will document/mark on this image map to identify areas in which persistent or recurrent pain was felt.
Acute pain based on The Michigan Body Map 7 days post surgery Participants will document/mark on this image map to identify areas in which persistent or recurrent pain was felt.
Healthcare Utilization related to pain at 1 month within 1 months after surgery Participants will answer questions about their healthcare utilization related to pain for the time period from date of surgery to one month later for the following three events: (1) postoperative clinical interactions related to pain in the form of patient messages, phone calls, and non-routine clinic visits related to pain, (2) emergency room visits, and (3) hospitalizations. The study team will also review health record for the same events.
PROMIS Preference score 29+2 Profile v2.1 3 months This is a 31 question survey that includes questions to evaluate each of 7 domains (physical function, anxiety, depression, fatigue, sleep disturbance, social functioning, and pain interference) using a 5- point Likert scale, as well as a single item to assess pain severity on a 0-10 scale as well as 2 questions for cognitive function. Higher scores are indicative of better health.
Substance use based on the Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) tool 180 days post surgery This National Institute on Drug Abuse (NIDA) TAPS tool has part 1 (5 questions) and part 2 (possible 9 questions).
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 The study team will review charts for unplanned postoperative clinical interactions related to pain (patient messages, phone calls, non-routine clinic visits related to pain) and emergency room visits, hospitalizations, and 30-day complications after discharge measured using the American College of Surgeons' (ACS) National Surgical Quality Improvement Program (NSQIP) definitions.
Healthcare Utilization related to pain at 6 months within 6 months after surgery Participants will answer questions about their healthcare utilization related to pain for the time period from date of surgery to six months later related to pain for the following three events: (1) postoperative clinical interactions in the form of patient messages, phone calls, and non-routine clinic visits related to pain, (2) emergency room visits, and (3) hospitalizations. The study team will also review health record for the same events.
Trial Locations
- Locations (5)
Temple University - Temple Health
🇺🇸Philadelphia, Pennsylvania, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Washington University in Saint Louis
🇺🇸Saint Louis, Missouri, United States
Unity Health Toronto
🇨🇦Toronto, Ontario, Canada