Clinical trial NCT05722002: Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial
Official title: Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Surgery
Pain, Postoperative
Keywords: Medications after surgery
NSAIDS
Acetaminophen
Opioids
laparoscopic gallbladder removal
inguinal hernia repair
breast lumpectomy
Analgesics, non-narcotic
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2023-02-10
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization of patients will be stratified by site, sex, age (greater or equal to 65 years old), and type of surgery, via permuted block randomization with a variable block size.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 7 days post surgery
timeFrame: 7 days post surgery
measure: Safety outcome - number and severity of any adverse medication-related symptoms over 7 days post surgery
timeFrame: 7 days post surgery
Secondary outcomes:
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance v1.0 4a questionnaire
timeFrame: 1 month post surgery
measure: Clinically important adverse events
timeFrame: 180 days post surgery
measure: Patient Global Impression of Change (PGIC)
timeFrame: up to 1 month after surgery
measure: Quality of Recovery (QoR) 15
timeFrame: 3 days post surgery
measure: Quality of Recovery (QoR) 15
timeFrame: 7 days post surgery
measure: PROMIS Pain Interference 4a
timeFrame: 3 months
measure: PROMIS Preference score 29+2 Profile v2.1
timeFrame: 3 months
measure: Substance use based on the Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) tool
timeFrame: 180 days post surgery
measure: National Survey on Drug Use and Health Questions (NSDUH) on Opioid Misuse opioid misuse question
timeFrame: 3 months
measure: National Survey on Drug Use and Health Questions (NSDUH) on Opioid Misuse opioid misuse question
timeFrame: 180 days
measure: New prolonged opioid use
timeFrame: days 4-180 post surgery
measure: Chronic pain based on Brief Pain Inventory (BPI) pain intensity score at 180 days post surgery
timeFrame: 180 days post surgery
measure: Chronic pain based on Body Map
timeFrame: 180 days post surgery
measure: Acute pain based on The Michigan Body Map
timeFrame: 7 days post surgery
measure: Healthcare Utilization related to pain at 1 month
timeFrame: within 1 months after surgery
measure: Healthcare Utilization related to pain at 6 months
timeFrame: within 6 months after surgery
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Louis
country: United States
facility: Washington University in Saint Louis
state: Missouri
city: Philadelphia
country: United States
facility: Temple University - Temple Health
state: Pennsylvania
city: Toronto
country: Canada
facility: Unity Health Toronto
state: Ontario
Study officials:
affiliation: University of Michigan
name: Mark Bicket, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: