T3AI-Pain After Breast Surgery (T3AI)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Breast Diseases
• Intervention / Treatment: Drug: acetaminophen plus codeine; Drug: acetaminophen plus ibuprofen

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
• Enrollment (Anticipated): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • QEII Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2	Drug: acetaminophen plus ibuprofen; capsules four times daily until pain free or for a maximum of seven days
Active Comparator: 1	Drug: acetaminophen plus codeine; capsules four times daily until pain free or for a maximum of seven days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
VAS Scores.	mean and daily
maximum VAS scores.	daily
Likert scores.	mean daily and final
Patient satisfaction with analgesic regimen.	day 7
Treatment failures-inadequate pain relief or inability to tolerate side effects.	daily
Time to stopping medication.	day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
Total Pain relief (TOTPAR).	daily
Sum of pain intensity differences (SPID).	day7
Amount of medication used.	day 7
Incidence of side effects.	day 7
Compliance with regimen.	day 7

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Investigators: Principal Investigator: Alex D Mitchell, MD, CDHA, Dalhousie University

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: March 2, 2006
• First Submitted That Met QC Criteria: March 3, 2006
• First Posted (Estimate): March 6, 2006

Study Record Updates

• Last Update Posted (Estimate): February 2, 2009
• Last Update Submitted That Met QC Criteria: January 30, 2009
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Analgesia; Clinical trial; Outpatient surgery; Breast tumor 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: Skin Diseases; Breast Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Acetaminophen; Ibuprofen; Codeine
• Other Study ID Numbers: CDHA008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No