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

University of Michigan

Status and phase: Enrolling; Phase 4

Conditions: Surgery; Pain, Postoperative

Treatments: Drug: NSAID; Drug: Acetaminophen; Drug: Opioid

Study type: Interventional

Funder types: Other

Identifiers

NCT05722002

HUM00215416

CER-2021C1-22398 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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900 participants in 2 patient groups

NSAID regimen

Other group

Description:

Surgical teams will elect for one of the medications within the treatment arm to which the patient is randomized.

Treatment:

Drug: Acetaminophen

Drug: NSAID

Opioid regimen

Other group

Treatment:

Drug: Opioid

Drug: Acetaminophen