T3AI-Pain After Breast Surgery (T3AI)

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

Study Description

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 Design

• 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
• Actual Primary Completion Date: June 2008
• Actual Study Completion Date: September 2008

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Canada, Nova Scotia

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada, B3H 2Y9

Sponsors and Collaborators

Nova Scotia Health Authority

Investigators

• Principal Investigator: Alex D Mitchell, MD; CDHA, Dalhousie University

More Information

• Responsible Party: Dr. Alex Mitchell, Dalhousie University
• ClinicalTrials.gov Identifier: NCT00299039 History of Changes
• Other Study ID Numbers: CDHA008
• First Posted: March 6, 2006
• 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; 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:

Acetaminophen; Codeine; Breast Diseases; Skin Diseases; Ibuprofen; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Antitussive Agents; Respiratory System Agents