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

Surgery Clinical Trial

— CARES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05722002
• Other study ID #: HUM00215416
• Secondary ID: CER-2021C1-22398
• Status: Recruiting
• Phase: Phase 4
• Start date: February 6, 2023
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: Kendall Dubois, MS
• Phone: 734-232-0324
• Email: kendalld[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Surgery

Intervention

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)
• 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
• 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).

Locations

Country	Name	City	State
Canada	Unity Health Toronto	Toronto	Ontario
United States	University of Michigan	Ann Arbor	Michigan
United States	Henry Ford Health System	Detroit	Michigan
United States	Washington University in Saint Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Patient-Centered Outcomes Research Institute

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days post surgery
Primary	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.	7 days post surgery
Secondary	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).	1 month post surgery
Secondary	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.	180 days post surgery
Secondary	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).	up to 1 month after surgery
Secondary	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.	3 days post surgery
Secondary	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.	7 days post surgery
Secondary	PROMIS Pain Interference 4a	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.	3 months
Secondary	PROMIS Preference score 29+2 Profile v2.1	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.	3 months
Secondary	Substance use based on the Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) tool	This National Institute on Drug Abuse (NIDA) TAPS tool has part 1 (5 questions) and part 2 (possible 9 questions).	180 days post surgery
Secondary	National Survey on Drug Use and Health Questions (NSDUH) on Opioid Misuse opioid misuse question		3 months
Secondary	National Survey on Drug Use and Health Questions (NSDUH) on Opioid Misuse opioid misuse question		180 days
Secondary	New prolonged opioid use	This will include greater or equal to 1 opioid prescription post-discharge between 4-180 days post discharge.	days 4-180 post surgery
Secondary	Chronic pain based on Brief Pain Inventory (BPI) pain intensity score at 180 days post surgery	One question survey in which the participants rate pain intensity recorded (0-10), ten being the worst.	180 days post surgery
Secondary	Chronic pain based on Body Map	Participants will document/mark on this image map to identify areas in which persistent or recurrent pain was felt.	180 days post surgery
Secondary	Acute pain based on The Michigan Body Map	Participants will document/mark on this image map to identify areas in which persistent or recurrent pain was felt.	7 days post surgery
Secondary	Healthcare Utilization related to pain at 1 month	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.	within 1 months after surgery
Secondary	Healthcare Utilization related to pain at 6 months	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.	within 6 months after surgery