T3AI-Pain After Breast Surgery (NCT00299039) | Clinical Trial Compass
CompletedPhase 3
T3AI-Pain After Breast Surgery
Canada150 participantsStarted 2006-05
Plain-language summary
Current standard of care for post-operative analgesia after breast surgery in CDHA is Tylenol #3® (300 mg acetaminophen, 30 mg codeine, 15 mg caffeine per tablet). We are proposing to test the analgesic efficacy of acetaminophen plus ibuprofen against Tylenol #3® in patients undergoing outpatient breast surgery.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ages 18 to 70 inclusive
* outpatient breast surgery: lumpectomy; mastectomy, simple or modified; with or without sentinel lymph node biopsy, axillary node dissection.
Exclusion Criteria:
* allergies to acetaminophen, NSAIDs, ASA or codeine.
* asthma.
* recent reported history of upper GI bleeding.
* daily analgesic use (OTC or opioid) pre-operatively.
* any opioid use in the week prior to surgery.
* reported history of PUD if not on PPI regularly.
* anticoagulant use (low dose ASA excepted).
* renal disease or impairment.
* reported history of liver disease.
* pregnancy.
* major operative complications.
* patients requiring admission.
* communication barrier.
* cognitive or memory impairment.
* reported history of drug and/or alcohol abuse.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
VAS Scores.
Timeframe: mean and daily
2
maximum VAS scores.
Timeframe: daily
3
Likert scores.
Timeframe: mean daily and final
4
Patient satisfaction with analgesic regimen.
Timeframe: day 7
5
Treatment failures-inadequate pain relief or inability to tolerate side effects.