T3AI-Pain After Breast Surgery

Breast Diseases, Pain

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

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.

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.

No related papers found yet.

Canada