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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
900
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)
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 1000 mg by mouth every 6 hours around the clock for the first three days after surgery then as needed thereafter (20 doses).
University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGHenry Ford Health System
Detroit, Michigan, United States
RECRUITINGWashington University in Saint Louis
St Louis, Missouri, United States
RECRUITINGCooper University Health Care
Camden, New Jersey, United States
RECRUITINGUniversity of North Carolina Hospitals
Chapel Hill, North Carolina, United States
RECRUITINGTemple University - Temple Health
Philadelphia, Pennsylvania, United States
RECRUITINGWomen's College Hospital
Toronto, Ontario, Canada
RECRUITINGUnity Health Toronto
Toronto, Ontario, Canada
RECRUITINGPain 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.
Time frame: 7 days post surgery
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.
Time frame: 7 days post surgery
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).
Time frame: 1 month post surgery
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.
Time frame: 180 days post surgery
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).
Time frame: up to 1 month after surgery
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.
Time frame: 3 days post surgery
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.
Time frame: 7 days post surgery
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.
Time frame: 3 months
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.
Time frame: 3 months
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).
Time frame: 180 days post surgery
National Survey on Drug Use and Health Questions (NSDUH) on Opioid Misuse opioid misuse question
Time frame: 3 months
National Survey on Drug Use and Health Questions (NSDUH) on Opioid Misuse opioid misuse question
Time frame: 180 days
New prolonged opioid use
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
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.
Time frame: 180 days post surgery
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.
Time frame: 180 days post surgery
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.
Time frame: 7 days post surgery
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.
Time frame: within 1 months after surgery
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.
Time frame: within 6 months after surgery
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