T3AI-Pain After Breast Surgery

Condition(s) targeted: Pain; Breast Diseases

Intervention: acetaminophen plus codeine (Drug); acetaminophen plus ibuprofen (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Capital District Health Authority, Canada

Official(s) and/or principal investigator(s):
Alex D Mitchell, MD, Principal Investigator, Affiliation: CDHA, Dalhousie University

Overall contact:
Alex D Mitchell, MD, Phone: 430-5995, Email: admitche@dal.ca

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

VAS Scores.

maximum VAS scores.

Likert scores.

Patient satisfaction with analgesic regimen.

Treatment failures-inadequate pain relief or inability to tolerate side effects.

Time to stopping medication.

Secondary outcome:

Total Pain relief (TOTPAR).

Sum of pain intensity differences (SPID).

Amount of medication used.

Incidence of side effects.

Compliance with regimen.

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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

- 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.

Alex D Mitchell, MD, Phone: 430-5995, Email: admitche@dal.ca

QEII Health Sciences Centre, Halifax, Nova Scotia B3H 2Y9, Canada; Recruiting
Alex D Mitchell, MD, Phone: 430-5995, Email: admitche@dal.ca
Karen Inglis, BScN, RN, CCRP, Phone: 902.473-5104
Alex D Mitchell, MD, Principal Investigator

Starting date: May 2006
Ending date: December 2008
Last updated: May 30, 2008