Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

T3AI-Pain After Breast Surgery

This study has been completed.
Sponsor:
Information provided by:
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00299039
First received: March 2, 2006
Last updated: January 30, 2009
Last verified: September 2008
  Purpose

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
Pain
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2Y9
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
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
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

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

ClinicalTrials.gov processed this record on November 24, 2014