T3AI-Pain After Breast Surgery

Pain Clinical Trial

— T3AI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00299039
• Other study ID #: CDHA008
• Status: Completed
• Phase: Phase 3
• First received: March 2, 2006
• Last updated: January 30, 2009
• Start date: May 2006
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Diseases
• Pain

Intervention

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

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS Scores.		mean and daily	No
Primary	maximum VAS scores.		daily	No
Primary	Likert scores.		mean daily and final	No
Primary	Patient satisfaction with analgesic regimen.		day 7	No
Primary	Treatment failures-inadequate pain relief or inability to tolerate side effects.		daily	No
Primary	Time to stopping medication.		day 7	No
Secondary	Total Pain relief (TOTPAR).		daily	No
Secondary	Sum of pain intensity differences (SPID).		day7	No
Secondary	Amount of medication used.		day 7	No
Secondary	Incidence of side effects.		day 7	No
Secondary	Compliance with regimen.		day 7	No