T3AI-Pain After Breast Surgery

Phase 3

Completed

• Conditions: Pain; Breast Diseases
• Interventions: Drug: acetaminophen plus codeine; Drug: acetaminophen plus ibuprofen

• Registration Number: NCT00299039
• Lead Sponsor: Nova Scotia Health Authority

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.

Study Timeline

• Study First Submitted: 2006-03-02
• Study First Submitted QC: 2006-03-03
• Study First Posted: 2006-03-06
• Study Start: 2006-05
• Primary Completion: 2008-06
• Status Verified: 2008-09
• Study Completion: 2008-09
• Last Update Submitted: 2009-01-30
• Last Update Posted: 2009-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	acetaminophen plus codeine	-
2	acetaminophen plus ibuprofen	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

QEII Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada