Risk of Hematoma After Ketorolac Use in Reduction Mammoplasty.

September 8, 2017 updated by: McMaster University

Does Ketorolac Increase the Risk of Hematoma After Reduction Mammoplasty? A Case-control Study.

The investigators hope to answer the question, "does ketorolac increase the risk of hematoma after reduction mammoplasty?" using a case-control study. All patients who developed a hematoma post reduction mammoplasty (cases) at our institution, and match these with women who had an uncomplicated reduction mammoplasty (controls), and then compare frequency of ketorolac exposure between these two groups as the primary outcome. If ketorolac increases the risk of hematoma, one should expect cases to have been exposed to ketorolac more frequently than controls. Based on previously existing literature, the investigators hypothesize that cases and controls will not differ in their ketorolac exposure, that is, ketorolac does not increase the risk of hematoma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The electronic health record databases of St. Joseph's Healthcare Hamilton and Hamilton Health Sciences will be searched, using the coding system, for all cases of reduction mammoplasty with post--operative hematoma as a complication. Only hematomas which required return to the operating room for evacuation will be included (i.e. those treated with observation or needle aspiration will be excluded).

Cases are defined as patients suffering a hematoma post reduction mammoplasty will be identified through hospital coding, and matched with controls based on the following criteria: age, body mass index (BMI), pre-existing hypertension, and institution. Controls are defined as patients who had uncomplicated reduction mammoplasty, and will be randomly pulled through retrospective chart review within the same databases, in the same time period (±5 years).

All patient data will be de--identified, and all devices containing patient information will remain on hospital grounds, and be encrypted according to our hospital protocols. The following data will be extracted from patient charts: age, date of surgery, body mass index, surgeon, anesthetist, volume of breast tissue removed per breast, comorbidities, platelet count, coagulation profile, ketorolac and opioid use including dose, timing, frequency, duration, and route of administration of both, time to discharge including length of stay if overnight, comorbidities (including smoking status), American Society of Anesthesiology score, and post--operative usage of drains.

Matching of cases and controls will be performed by the primary investigator (JB), and at the time of matching, the only visible patient information will be the de-identified patient identification (ID) and the four matching variables (ketorolac exposure was not visible).

The frequency of ketorolac exposure between cases and controls will then be reviewed, and the odds ratio (OR) of exposure to ketorolac, with 95% confidence intervals will be calculated. A two by two table will be generated from our data. Since the incidence of hematoma formation after reduction mammoplasty is very low, the odds ratio will closely approximate the relative risk. To evaluate the statistical significance of the ORs, a level of significance of 0.05 will be used. Independent samples t-test will be used to compare continuous demographic data, and Chi-square analysis will be used for ordinal or categorical data between cases and controls.

Sample size was calculated using the POWER program, described by Dupont and Plummer in 1990. A sample size of 25 cases matched with 25 controls (total n = 50) was required from the following data:

  • p0 = 0.32 (approximate rate of ketorolac exposure amongst breast reduction patients from previous literature from Cawthorn et al.)
  • α = 0.05 (chance of type I error)
  • P = 0.8 (power)
  • m = 1 (matching ratio1:1)
  • Ψ = 3.6 (estimated risk ratio of developing hematoma post breast reduction if exposed to ketorolac, Cawthorn et al.)
  • Φ = 0.2 (measurable difference)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • St. Joseph's Healthcare Hamilton
      • Hamilton, Ontario, Canada, L8N3Z5
        • Hamilton Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Medical coders will identify all possible cases of hematoma by searching the key words "hemorrhage," "hematoma," and "plastic surgery". Hematomas post reduction mammoplasty will be manually retrieved and reviewed. Control patients will be randomly pulled from the database of uncomplicated reduction mammoplasties.

Description

Inclusion Criteria:

Cases:

- Patients who developed hematoma post-reduction mammoplasty requiring repeat surgery

Controls:

- Uncomplicated bilateral reduction mammoplasty

Exclusion Criteria:

  • Hematoma patients treated with observation or needle aspiration
  • Concomitant surgeries in addition to the reduction mammoplasty
  • Allergy/sensitivity to non-steroidal anti-inflammatory drugs
  • Unilateral reduction mammoplasty
  • Male reduction mammoplasty
  • Documented bleeding disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cases
Women who underwent reduction mammoplasty and then developed a hematoma which required return to the operating room for evacuation.
Procedure: Hematoma
Hematoma requiring return to operating room.
Controls
Women who had uncomplicated reduction mammoplasty.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ketorolac exposure.
Time Frame: Sept 2015 - Aug 2017.
Whether or not cases and controls were exposed to ketorolac on the day of surgery will be determined and compiled as a categorical variable (yes/no).
Sept 2015 - Aug 2017.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Year of reduction mammoplasty.
Time Frame: Sept 2015 - Aug 2017.
The year of which the reduction mammoplasty occurred will be recorded for cases and controls. The investigators will then calculate the mean year which the reduction mammoplasty surgery occurred for the case and control groups, to ensure that on average, each group is similar in terms of the year the surgeries occurred.
Sept 2015 - Aug 2017.
Age of patients in each group will be calculated.
Time Frame: Sept 2015 - Aug 2017.
Age, extracted from the medical chart, will be aggregated and mean age for cases and controls will be calculated.
Sept 2015 - Aug 2017.
Body mass index compared between cases and controls.
Time Frame: Sept 2015 - Aug 2017.
BMI will be calculated for each patient from height and weight available in the medical chart, and mean BMI between case and control groups will be compared.
Sept 2015 - Aug 2017.
Volume of breast tissue resected during surgery (in grams) for each patient.
Time Frame: Sept 2015 - Aug 2017.
Mean volume of breast tissue resected from each breast, which is a routinely recorded number during reduction mammoplasty, will be extracted for each patient, and mean volumes resected will be compared between cases and controls.
Sept 2015 - Aug 2017.
Pre-operative platelet count.
Time Frame: Sept 2015 - Aug 2017.
Platelet counts, if available, will be extracted for each patient and means for cases and controls will be compared.
Sept 2015 - Aug 2017.
Smoking status.
Time Frame: Sept 2015 - Aug 2017.
Active smokers (yes/no) will be determined by reviewing the pre-operative anesthesia records which routinely contain this information.
Sept 2015 - Aug 2017.
American society of anesthesiologist (ASA) score.
Time Frame: Sept 2015 - Aug 2017.
This is an ordinal score (ASA 1 through 4) given to all patients pre-operatively, as a general indicator of risk of morbidity and mortality with a general anesthetic. This will be extracted for each patient from the pre-operative anesthesia records and frequencies of patients who are ASA 1, ASA 2, ASA 3, or ASA 4 will be aggregated and compared between cases and controls.
Sept 2015 - Aug 2017.
Specific breast side of hematoma occurrence (left versus right).
Time Frame: Sept 2015 - Aug 2017.
In patients who developed a hematoma (cases), the investigators will record whether this occurred on the left, right, or both breasts.
Sept 2015 - Aug 2017.
Post-operative opioid consumption.
Time Frame: Sept 2015 - Aug 2017.
The investigators will calculate post-operative opioid consumption for each patient in the study. Values will be converted to equivalence of oral morphine, in milligrams, using standard conversion charts. Mean opioid consumption will be compared between patients who received ketorolac and those who did not.
Sept 2015 - Aug 2017.
Surgeon's description of bleeding encountered during hematoma take-back.
Time Frame: Sept 2015 - Aug 2017.
The investigators will review transcribed dictations of the surgeon for hematoma cases in order to determine what type of bleeding was encountered during take-back surgery. The categorical descriptors will be: pulsatile bleeding, general ooze, or both. The investigators will compare descriptors between patients who received ketorolac and those who did not.
Sept 2015 - Aug 2017.
Ketorolac dose.
Time Frame: Sept 2015 - Aug 2017.
Amongst cases and controls who received ketorolac, the specific dose of ketorolac given will be recorded in milligrams.
Sept 2015 - Aug 2017.
Ketorolac route given.
Time Frame: Sept 2015 - Aug 2017.
Amongst cases and controls who received ketorolac, the route which ketorolac was given will be recorded as a categorical variable (intra-venous, intra-muscular, or oral).
Sept 2015 - Aug 2017.
Timing of ketorolac dose.
Time Frame: Sept 2015 - Aug 2017.
Amongst cases and controls who received ketorolac, the timing of the dose given will be recorded (i.e. pre-operative, intra-operative, or post-operative).
Sept 2015 - Aug 2017.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Achilleas Thoma, MD, MSc, BSc, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1094-C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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