T3AI-Pain After Breast Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3® for the Treatment of Pain After Breast Surgery.

Conditions
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Pain, Breast Diseases

Intervention / Treatment
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* Drug: acetaminophen plus codeine
* Drug: acetaminophen plus ibuprofen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: acetaminophen plus codeine<br>* capsules four times daily until pain free or for a maximum of seven days<br>|
| Active Comparator: 2<br> | Drug: acetaminophen plus ibuprofen<br>* capsules four times daily until pain free or for a maximum of seven days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized controlled trial, Clinical trial, Breast tumor surgery, Outpatient surgery, Analgesia, Outpatient analgesia, Post surgical analgesia, ≥ 18 and ≤ 70 years of age, Elective outpatient breast surgery for:, lumpectomy/quadrantectomy +/- Sentinel Lymph Node Biopsy, lumpectomy/quadrantectomy with Axillary Node Dissection, simple mastectomy +/- Sentinel Lymph Node Biopsy, Modified Radical mastectomy