Recruiting NCT05722002
Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NSAID, Opioid, Acetaminophen.
- Who it may be relevant to
- Registry conditions: Surgery, Pain, Postoperative. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug NSAID
Once 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) - Drug Opioid
Once 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 - Drug Acetaminophen
Acetaminophen 1000 mg by mouth every 6 hours around the clock for the first three days after surgery then as needed thereafter (20 doses).
Primary outcome measures
- 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]
- Safety outcome - number and severity of any adverse medication-related symptoms over 7 days post surgery [Time frame: 7 days post surgery]
Secondary outcome measures (12)
- Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance v1.0 4a questionnaire [Time frame: 1 month post surgery]
- Clinically important adverse events [Time frame: 180 days post surgery]
- Patient Global Impression of Change (PGIC) [Time frame: up to 1 month after surgery]
- Quality of Recovery (QoR) 15 [Time frame: 3 days post surgery]
- Quality of Recovery (QoR) 15 [Time frame: 7 days post surgery]
- PROMIS Pain Interference 4a [Time frame: 3 months]
- PROMIS Preference score 29+2 Profile v2.1 [Time frame: 3 months]
- Substance use based on the Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) tool [Time frame: 180 days post surgery]
- National Survey on Drug Use and Health Questions (NSDUH) on Opioid Misuse opioid misuse question [Time frame: 3 months]
- National Survey on Drug Use and Health Questions (NSDUH) on Opioid Misuse opioid misuse question [Time frame: 180 days]
- New prolonged opioid use [Time frame: days 4-180 post surgery]
- Chronic pain based on Brief Pain Inventory (BPI) pain intensity score at 180 days post surgery [Time frame: 180 days post surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- University of Michigan — Ann Arbor
- Henry Ford Health System — Detroit
- Washington University in Saint Louis — St Louis
- Cooper University Health Care — Camden
- University of North Carolina Hospitals — Chapel Hill
- Temple University - Temple Health — Philadelphia
Canada · 2 centers
- Women's College Hospital — Toronto
- Unity Health Toronto — Toronto
Publications
- Bicket MC, Ladha KS, Haroutounian S, McFarlin K, Neff M, McDuffie RL, Waljee JF, Wijeysundera DN, Brummet C, Li Y; CARES Investigators. Comparing Analgesic Regimen Effectiveness and Safety after Surgery (CARES): protocol for a pragmatic, international multicentre randomised trial. BMJ Open. 2025 Apr 5;15(4):e099925. doi: 10.1136/bmjopen-2025-099925. PMID 40187774
Identifiers
NCT: NCT05722002 · HUM00215416 · CER-2021C1-22398