Clinical trial NCT00299039: T3AI-Pain After Breast Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Breast Diseases
Keywords: 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
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2006-03-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: VAS Scores.
timeFrame: mean and daily
measure: maximum VAS scores.
timeFrame: daily
measure: Likert scores.
timeFrame: mean daily and final
measure: Patient satisfaction with analgesic regimen.
timeFrame: day 7
measure: Treatment failures-inadequate pain relief or inability to tolerate side effects.
timeFrame: daily
measure: Time to stopping medication.
timeFrame: day 7
Secondary outcomes:
measure: Total Pain relief (TOTPAR).
timeFrame: daily
measure: Sum of pain intensity differences (SPID).
timeFrame: day7
measure: Amount of medication used.
timeFrame: day 7
measure: Incidence of side effects.
timeFrame: day 7
measure: Compliance with regimen.
timeFrame: day 7
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: CDHA, Dalhousie University
name: Alex D Mitchell, MD
role: PRINCIPAL_INVESTIGATOR
References: