T3AI-Pain After Breast Surgery
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Block randomization will be used to randomize patients to one of two combinations. Group A will receive capsules containing 650 mg Acetaminophen plus 400 mg Ibuprofen. Group B will receive capsules containing 600 mg Acetaminophen, 15 mg caffeine and 60 mg codeine. Capsules are placed in identical dossettes containing a seven day supply. Patients are instructed to start taking their medications post-op and continue until they are pain free. All participants are given a series of blank Visual Analogue scales and Likert scales and instructed to record their level of pain intensity and pain relief four times per day for the entire week. Peri-operative pain management will be standardized. Patients will not receive pre-operative analgesics. Intra-operative analgesia will be intravenous opioids as selected by anaesthesiology. No local/regional anaesthesia will be used. Intravenous ketorolac will not be allowed for trial participants. All patients will receive intravenous opioid and anti-emetic if required in PACU. Any patients with peri-operative complications or other problems requiring admission or alternative analgesics will be excluded.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1
|
Drug: acetaminophen plus codeine
capsules four times daily until pain free or for a maximum of seven days
|
| Active Comparator: 2
|
Drug: acetaminophen plus ibuprofen
capsules four times daily until pain free or for a maximum of seven days
|
Outcome Measures
Primary Outcome Measures
- VAS Scores. [mean and daily]
- maximum VAS scores. [daily]
- Likert scores. [mean daily and final]
- Patient satisfaction with analgesic regimen. [day 7]
- Treatment failures-inadequate pain relief or inability to tolerate side effects. [daily]
- Time to stopping medication. [day 7]
Secondary Outcome Measures
- Total Pain relief (TOTPAR). [daily]
- Sum of pain intensity differences (SPID). [day7]
- Amount of medication used. [day 7]
- Incidence of side effects. [day 7]
- Compliance with regimen. [day 7]
Eligibility Criteria
Criteria
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.
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any opioid use in the week prior to surgery.
-
reported history of PUD if not on PPI regularly.
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anticoagulant use (low dose ASA excepted).
-
renal disease or impairment.
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reported history of liver disease.
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pregnancy.
-
major operative complications.
-
patients requiring admission.
-
communication barrier.
-
cognitive or memory impairment.
-
reported history of drug and/or alcohol abuse.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | QEII Health Sciences Centre | Halifax | Nova Scotia | Canada | B3H 2Y9 |
Sponsors and Collaborators
- Nova Scotia Health Authority
Investigators
- Principal Investigator: Alex D Mitchell, MD, CDHA, Dalhousie University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDHA008