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Completed

NCT Number: NCT00299039

T3AI-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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acetaminophen plus codeine

Drug

capsules four times daily until pain free or for a maximum of seven days

acetaminophen plus ibuprofen

Drug

capsules four times daily until pain free or for a maximum of seven days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

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

Acronym: T3AI

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 6, 2006
Registry last updated
Feb 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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