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

Primary Purpose

Surgery, Pain, Postoperative

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
NSAID
Opioid
Acetaminophen
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery focused on measuring Medications after surgery, NSAIDS, Acetaminophen, Opioids, laparoscopic gallbladder removal, inguinal hernia repair, breast lumpectomy, Analgesics, non-narcotic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of MichiganRecruiting
  • Henry Ford Health System
  • Washington University in Saint Louis
  • Unity Health Toronto

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

NSAID regimen

Opioid regimen

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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.
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).
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.
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.
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.
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.
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).
National Survey on Drug Use and Health Questions (NSDUH) on Opioid Misuse opioid misuse question
National Survey on Drug Use and Health Questions (NSDUH) on Opioid Misuse opioid misuse question
New prolonged opioid use
This will include greater or equal to 1 opioid prescription post-discharge between 4-180 days post discharge.
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.
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.
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.
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.
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.

Full Information

First Posted
January 30, 2023
Last Updated
February 9, 2023
Sponsor
University of Michigan
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05722002
Brief Title
Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial
Acronym
CARES
Official Title
Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Pain, Postoperative
Keywords
Medications after surgery, NSAIDS, Acetaminophen, Opioids, laparoscopic gallbladder removal, inguinal hernia repair, breast lumpectomy, Analgesics, non-narcotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Both study staff performing outcome assessment and data analysis will be masked to treatment assignment.
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NSAID regimen
Arm Type
Other
Arm Description
Surgical teams will elect for one of the medications within the treatment arm to which the patient is randomized.
Arm Title
Opioid regimen
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
NSAID
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Opioid
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
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 Measure Information:
Title
Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 7 days post surgery
Description
This is a one question survey in which the worst pain intensity recorded (0-10 being the worst) will be used.
Time Frame
7 days post surgery
Title
Safety outcome - number and severity of any adverse medication-related symptoms over 7 days post surgery
Description
Symptom Checklist will proactively screen patients for reports of adverse events from analgesic medications over the first 7 days post surgery.
Time Frame
7 days post surgery
Secondary Outcome Measure Information:
Title
Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance v1.0 4a questionnaire
Description
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).
Time Frame
1 month post surgery
Title
Clinically important adverse events
Description
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.
Time Frame
180 days post surgery
Title
Patient Global Impression of Change (PGIC)
Description
The perception of improvement after treatment will be assessed by the patient global impression of change PGIC (range 0-7).
Time Frame
up to 1 month after surgery
Title
Quality of Recovery (QoR) 15
Description
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.
Time Frame
3 days post surgery
Title
Quality of Recovery (QoR) 15
Description
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.
Time Frame
7 days post surgery
Title
PROMIS Pain Interference 4a
Description
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.
Time Frame
3 months
Title
PROMIS Preference score 29+2 Profile v2.1
Description
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.
Time Frame
3 months
Title
Substance use based on the Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) tool
Description
This National Institute on Drug Abuse (NIDA) TAPS tool has part 1 (5 questions) and part 2 (possible 9 questions).
Time Frame
180 days post surgery
Title
National Survey on Drug Use and Health Questions (NSDUH) on Opioid Misuse opioid misuse question
Time Frame
3 months
Title
National Survey on Drug Use and Health Questions (NSDUH) on Opioid Misuse opioid misuse question
Time Frame
180 days
Title
New prolonged opioid use
Description
This will include greater or equal to 1 opioid prescription post-discharge between 4-180 days post discharge.
Time Frame
days 4-180 post surgery
Title
Chronic pain based on Brief Pain Inventory (BPI) pain intensity score at 180 days post surgery
Description
One question survey in which the participants rate pain intensity recorded (0-10), ten being the worst.
Time Frame
180 days post surgery
Title
Chronic pain based on Body Map
Description
Participants will document/mark on this image map to identify areas in which persistent or recurrent pain was felt.
Time Frame
180 days post surgery
Title
Acute pain based on The Michigan Body Map
Description
Participants will document/mark on this image map to identify areas in which persistent or recurrent pain was felt.
Time Frame
7 days post surgery
Title
Healthcare Utilization related to pain at 1 month
Description
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.
Time Frame
within 1 months after surgery
Title
Healthcare Utilization related to pain at 6 months
Description
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.
Time Frame
within 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kendall Dubois, MS
Phone
734-232-0324
Email
kendalld@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Bicket, MD, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendall Dubois
Phone
734-232-0324
Email
Kendalld@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Mark Bicket, MD, PhD
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Marsack
Phone
313-916-2600
Email
kmarsac1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Kellie McFarlin, MD, FACS
Facility Name
Washington University in Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Stout, PhD, MSc
Phone
314-273-2455
Email
justinjstout@wustl.edu
First Name & Middle Initial & Last Name & Degree
Simon Haroutounian, PhD, MSc
Facility Name
Unity Health Toronto
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janneth P Canizares
Phone
416-864-6060
Email
janneth.pazmino-canizares@unityhealth.to
First Name & Middle Initial & Last Name & Degree
Karim Ladha, MD, MSc, FRCPC

12. IPD Sharing Statement

Plan to Share IPD
No

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

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