T3AI-Pain After Breast Surgery

Nova Scotia Health Authority (NSHA)

Status and phase: Completed; Phase 3

Conditions: Breast Diseases; Pain

Treatments: Drug: acetaminophen plus ibuprofen; Drug: acetaminophen plus codeine

Study type: Interventional

Funder types: Other

Identifiers

NCT00299039

CDHA008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

1

Active Comparator group

Treatment:

Drug: acetaminophen plus codeine

2

Active Comparator group

Treatment:

Drug: acetaminophen plus ibuprofen