PainPhase 3T3AINCT00299039
T3AI-Pain After Breast Surgery
A Phase 3 study testing acetaminophen plus codeine and acetaminophen plus ibuprofen in people with Pain and Breast Diseases, run by Nova Scotia Health Authority at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Breast Diseases
- What is being tested?
- acetaminophen plus codeine and acetaminophen plus ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- May 2006to Sep 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ages 18 to 70 inclusive
- outpatient breast surgery: lumpectomy; mastectomy, simple or modified; with or without sentinel lymph node biopsy, axillary node dissection.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3® for the Treatment of 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.
Read the 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.
- Conditions
- Pain, Breast Diseases
- Being tested
- acetaminophen plus codeine, acetaminophen plus ibuprofen
- 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
- Medical subject headings
- Pain, Breast Diseases, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetaminophen plus codeineDrug
capsules four times daily until pain free or for a maximum of seven days
acetaminophen plus ibuprofenDrug
capsules four times daily until pain free or for a maximum of seven days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: acetaminophen plus codeine |
| 2 | Active comparator | Not described Receives: Drug: acetaminophen plus ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Scores.
Measured: mean and daily
maximum VAS scores.
Measured: daily
Likert scores.
Measured: mean daily and final
Patient satisfaction with analgesic regimen.
Measured: day 7
Treatment failures-inadequate pain relief or inability to tolerate side effects.
Measured: daily
Time to stopping medication.
Measured: day 7
Secondary outcomes (5)
Total Pain relief (TOTPAR).
Measured: daily
Sum of pain intensity differences (SPID).
Measured: day7
Amount of medication used.
Measured: day 7
Incidence of side effects.
Measured: day 7
Compliance with regimen.
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2006 (estimated)
- Study startMay 2006
- Primary completionJun 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Investigators
- Alex D Mitchell, MD, Principal investigator, CDHA, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299039
- Sponsor's protocol ID
- CDHA008
- Acronym
- T3AI
- Status last verified
- Sep 2008
- First submitted
- 2 Mar 2006
- Last updated
- 2 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3® for the Treatment of Pain After Breast Surgery.
- ClinicalTrials.gov ID
- NCT00299039
- Acronym / sponsor ID
- T3AI / CDHA008
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 6 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: acetaminophen plus codeine |
| 2 | Active comparator | Drug: acetaminophen plus ibuprofen |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ages 18 to 70 inclusive
- outpatient breast surgery: lumpectomy; mastectomy, simple or modified; with or without sentinel lymph node biopsy, axillary node dissection.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetaminophen plus codeinecapsules four times daily until pain free or for a maximum of seven days | Drug | 1 |
| acetaminophen plus ibuprofencapsules four times daily until pain free or for a maximum of seven days | Drug | 2 |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex D Mitchell, MD principal investigator
CDHA, Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing acetaminophen plus codeine and acetaminophen plus ibuprofen in people with Pain and Breast Diseases, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS Scores. (time frame: mean and daily). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2009.