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NCT Number: NCT05722002

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

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Key information

Conditions

Surgery Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Unity Health Toronto, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NSAID

Drug

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)

Opioid

Drug

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

Acetaminophen

Drug

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 outcomes

  1. 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.

  2. 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

  1. Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance v1.0 4a questionnaire

    Time frame: 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).

  2. Clinically important adverse events

    Time frame: 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.

  3. Patient Global Impression of Change (PGIC)

    Time frame: 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).

  4. Quality of Recovery (QoR) 15

    Time frame: 3 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.

  5. Quality of Recovery (QoR) 15

    Time frame: 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.

  6. PROMIS Pain Interference 4a

    Time frame: 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.

  7. PROMIS Preference score 29+2 Profile v2.1

    Time frame: 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.

  8. Substance use based on the Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) tool

    Time frame: 180 days post surgery

    This National Institute on Drug Abuse (NIDA) TAPS tool has part 1 (5 questions) and part 2 (possible 9 questions).

  9. National Survey on Drug Use and Health Questions (NSDUH) on Opioid Misuse opioid misuse question

    Time frame: 3 months

  10. National Survey on Drug Use and Health Questions (NSDUH) on Opioid Misuse opioid misuse question

    Time frame: 180 days

  11. New prolonged opioid use

    Time frame: days 4-180 post surgery

    This will include greater or equal to 1 opioid prescription post-discharge between 4-180 days post discharge.

  12. Chronic pain based on Brief Pain Inventory (BPI) pain intensity score at 180 days post surgery

    Time frame: 180 days post surgery

    One question survey in which the participants rate pain intensity recorded (0-10), ten being the worst.

  13. Chronic pain based on Body Map

    Time frame: 180 days post surgery

    Participants will document/mark on this image map to identify areas in which persistent or recurrent pain was felt.

  14. Acute pain based on The Michigan Body Map

    Time frame: 7 days post surgery

    Participants will document/mark on this image map to identify areas in which persistent or recurrent pain was felt.

  15. Healthcare Utilization related to pain at 1 month

    Time frame: 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.

  16. Healthcare Utilization related to pain at 6 months

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Clark, BA

CONTACT

[email protected]

734-232-0324

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Acronym: CARES

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Feb 10, 2023
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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