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T3AI-Pain After Breast Surgery (T3AI)

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ClinicalTrials.gov Identifier: NCT00299039
Recruitment Status : Completed
First Posted : March 6, 2006
Last Update Posted : February 2, 2009
Information provided by:
Nova Scotia Health Authority

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Breast Diseases Drug: acetaminophen plus codeine Drug: acetaminophen plus ibuprofen Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : May 2006
Primary Completion Date : June 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. VAS Scores. [ Time Frame: mean and daily ]
  2. maximum VAS scores. [ Time Frame: daily ]
  3. Likert scores. [ Time Frame: mean daily and final ]
  4. Patient satisfaction with analgesic regimen. [ Time Frame: day 7 ]
  5. Treatment failures-inadequate pain relief or inability to tolerate side effects. [ Time Frame: daily ]
  6. Time to stopping medication. [ Time Frame: day 7 ]

Secondary Outcome Measures :
  1. Total Pain relief (TOTPAR). [ Time Frame: daily ]
  2. Sum of pain intensity differences (SPID). [ Time Frame: day7 ]
  3. Amount of medication used. [ Time Frame: day 7 ]
  4. Incidence of side effects. [ Time Frame: day 7 ]
  5. Compliance with regimen. [ Time Frame: day 7 ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299039

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

Responsible Party: Dr. Alex Mitchell, Dalhousie University
ClinicalTrials.gov Identifier: NCT00299039     History of Changes
Other Study ID Numbers: CDHA008
First Posted: March 6, 2006    Key Record Dates
Last Update Posted: February 2, 2009
Last Verified: September 2008

Keywords provided by Nova Scotia Health Authority:
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
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents