T3AI-Pain After Breast Surgery
Information source: Nova Scotia Health Authority
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Breast Diseases
Intervention: acetaminophen plus codeine (Drug); acetaminophen plus ibuprofen (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Nova Scotia Health Authority Official(s) and/or principal investigator(s): Alex D Mitchell, MD, Principal Investigator, Affiliation: CDHA, Dalhousie University
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.
Clinical Details
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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.
Eligibility
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.
Locations and Contacts
QEII Health Sciences Centre, Halifax, Nova Scotia B3H 2Y9, Canada
Additional Information
Starting date: May 2006
Last updated: January 30, 2009
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