Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
NSAID
DrugOnce randomized to this group the surgical team will elect for 1 of the following treatment options to be given: * Ibuprofen 600 milligram (mg) by mouth every six hours as needed for pain (10 doses) * Celecoxib 400 mg by mouth once then 200 mg every twelve hours as needed for pain (10 doses) * Naproxen 500 mg by mouth once then 250 mg by mouth every eight hours as needed for pain (10 doses)
Opioid
DrugOnce randomized to this group the surgical team will elect for 1 of the following treatment options to be given: * Oxycodone 5 mg by mouth every four to six hours as needed for pain, 10 doses * Morphine 7.5 mg by mouth every four to six hours as needed for pain, 10 doses * Hydromorphone 2 mg by mouth every four to six hours as needed for pain, 10 doses
Acetaminophen
DrugAcetaminophen 1000 mg by mouth every 6 hours around the clock for the first three days after surgery then as needed thereafter (20 doses).
Treatment groups
900 Participants
are divided into 2 treatment groupsGroup A: NSAID regimenOther 2 interventions
Group B: Opioid regimenOther 2 interventions
Trial outcomes
Primary outcomes
1
Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 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.
Time frame
7 days post surgery2
Safety outcome - number and severity of any adverse medication-related symptoms over 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.
Time frame
7 days post surgerySecondary outcomes
1
Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance v1.0 4a questionnaire
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).
Time frame
1 month post surgery2
Clinically important adverse events
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.
Time frame
180 days post surgery3
Patient Global Impression of Change (PGIC)
The perception of improvement after treatment will be assessed by the patient global impression of change PGIC (range 0-7).
Time frame
up to 1 month after surgery4
Quality of Recovery (QoR) 15
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.
Time frame
3 days post surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov