T3AI-Pain After Breast Surgery

This study has been completed.
Information provided by:
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
First received: March 2, 2006
Last updated: January 30, 2009
Last verified: September 2008

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.

Condition Intervention Phase
Breast Diseases
Drug: acetaminophen plus codeine
Drug: acetaminophen plus ibuprofen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3® for the Treatment of Pain After Breast Surgery.

Resource links provided by NLM:

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • VAS Scores. [ Time Frame: mean and daily ] [ Designated as safety issue: No ]
  • maximum VAS scores. [ Time Frame: daily ] [ Designated as safety issue: No ]
  • Likert scores. [ Time Frame: mean daily and final ] [ Designated as safety issue: No ]
  • Patient satisfaction with analgesic regimen. [ Time Frame: day 7 ] [ Designated as safety issue: No ]
  • Treatment failures-inadequate pain relief or inability to tolerate side effects. [ Time Frame: daily ] [ Designated as safety issue: No ]
  • Time to stopping medication. [ Time Frame: day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total Pain relief (TOTPAR). [ Time Frame: daily ] [ Designated as safety issue: No ]
  • Sum of pain intensity differences (SPID). [ Time Frame: day7 ] [ Designated as safety issue: No ]
  • Amount of medication used. [ Time Frame: day 7 ] [ Designated as safety issue: No ]
  • Incidence of side effects. [ Time Frame: day 7 ] [ Designated as safety issue: No ]
  • Compliance with regimen. [ Time Frame: day 7 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: May 2006
Study Completion Date: September 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: acetaminophen plus codeine
capsules four times daily until pain free or for a maximum of seven days
Active Comparator: 2 Drug: acetaminophen plus ibuprofen
capsules four times daily until pain free or for a maximum of seven days

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.


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299039

Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2Y9
Sponsors and Collaborators
Capital District Health Authority, Canada
Principal Investigator: Alex D Mitchell, MD CDHA, Dalhousie University
  More Information

No publications provided

Responsible Party: Dr. Alex Mitchell, Dalhousie University
ClinicalTrials.gov Identifier: NCT00299039     History of Changes
Other Study ID Numbers: CDHA008
Study First Received: March 2, 2006
Last Updated: January 30, 2009
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
Randomized controlled trial
Clinical trial
Breast tumor surgery
Outpatient surgery
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

Additional relevant MeSH terms:
Breast Diseases
Skin Diseases
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014