T3AI-Pain After Breast Surgery

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 2008

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.

Interventions

  • Drug: acetaminophen plus codeine
    • capsules four times daily until pain free or for a maximum of seven days
  • Drug: acetaminophen plus ibuprofen
    • capsules four times daily until pain free or for a maximum of seven days

Arms, Groups and Cohorts

  • Active Comparator: 1
  • Active Comparator: 2

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nova Scotia Health Authority
  • Provider of Information About this Clinical Study
    • Dr. Alex Mitchell, Dalhousie University
  • Overall Official(s)
    • Alex D Mitchell, MD, Principal Investigator, CDHA, Dalhousie University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.