Opioid UseNCT04058938
Pain in Breast Surgery Intervention
A study testing Educational handout instrument in people with Opioid Use and Pain, Postoperative, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This study will be a randomized control trial providing an educational component to study participants and a pre-operative and post-operative survey with a goal to show an improvement in pain control, decrease in narcotic use, and increase in patient knowledge in the study group. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Opioid Use, Pain, Postoperative
- What is being tested?
- Educational handout instrument
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 1 Mar 2020
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patients presenting for the first stage of breast reconstruction using tissue expanders
- Patients 18 years of age and older
Who cannot join
- Male patients
- Patients under age 18
- Patients who have had previous breast reconstruction or tissue expansion
- Patients who are not able to read English will be excluded from this study as the study materials will be in written English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: A Randomized Control Trial of Patient Education on Pain Control in Breast Surgery
This study will be a randomized control trial providing an educational component to study participants and a pre-operative and post-operative survey with a goal to show an improvement in pain control, decrease in narcotic use, and increase in patient knowledge in the study group.
Read the detailed description
The use of opioid pain medications in surgical patients is contributing to an epidemic of opioid pain medication use. It is known that the quality of pain control after surgery is a large factor of the patient's perception of their experience. However, little research has been done to improve pain control in plastic surgery patients. To the investigators knowledge, no study has yet looked at education of breast surgery patients to improve pain experience. The study goal is to survey breast surgery patients in the Plastic Surgery department before and after surgery to evaluate the participants experience with pain and pain medications. Half of the participants in the study will be randomized to receive an information sheet about pain control at the participants pre-operative appointment.
- Conditions
- Opioid Use, Pain, Postoperative
- Being tested
- Educational handout instrument, Control
- Keywords
- opioid use, breast reconstruction, pain control, mastectomy
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational handout instrumentBehavioural
The handout was single-paged (front and back), and was titled Pain After Surgery: What to Expect. The handout starts with information on rating pain and expectations for control of pain, not complete absence of pain, after surgery. Mutli-modal approach to pain control is then discussed, including pharmacologic and non-pharmacologic methods that may be used for pain control by the perioperative team and postoperatively.
ControlBehavioural
Standard patient counseling
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The control group received standard of care, including standard patient counseling from the surgical teams. Receives: Behavioral: Control |
| Intervention | Experimental | In conjunction with oncologic psychology and plastic surgery, an instrument was developed to be provided as a single-paged paper handout to the intervention group. The instrument included information about expectations for pain control, information about the pain scale, and examples of opioid and adjunct medications which may be used as part of a multi-modal approach to pain control during the perioperative period. Receives: Behavioral: Educational handout instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Opioid consumption will be calculated from patient report of remaining narcotics at the postoperative appointment and the total opioid amount prescribed, from the medical record.
Measured: 1-2 weeks
Secondary outcomes (1)
Pain control: survey
Patient report of subjective and objective pain control after surgery will be collected on a postoperative survey. Objective pain control will be scored by asking patients to circle a pain score on a scale of 0 to 10. This is a continuous scale used to score pain with 0 being no pain and 10 being the worst pain. Subjective pain will be rated by asking participants to state yes or no for control of pain and state yes or no if pain interfered with walking, sleeping, and activities of daily living.
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start1 Mar 2018
- Primary completion1 May 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All study participants received a study folder with information about the study and consent; the instrument was included in this folder for the intervention group. The control group received standard of care, including standard patient counseling from the surgical teams. In conjunction with oncologic psychology and plastic surgery, an instrument was developed to be provided as a single-paged paper handout to the intervention group. The instrument included information about expectations for pain control, information about the pain scale, and examples of opioid and adjunct medications which may be used as part of a multi-modal approach to pain control during the perioperative period.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katie Egan, University of Kansas Medical Center
- Investigators
- Richard Korentager, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058938
- Sponsor's protocol ID
- 00141330
- Status last verified
- Sep 2020
- First submitted
- 14 Aug 2019
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Patient Education on Pain Control in Breast Surgery
- ClinicalTrials.gov ID
- NCT04058938
- Acronym / sponsor ID
- 00141330
- Conditions
- Opioid Use, Pain, Postoperative
- Keywords
- opioid use, breast reconstruction, pain control, mastectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 16 Aug 2019 (actual)
- 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.
This study will be a randomized control trial providing an educational component to study participants and a pre-operative and post-operative survey with a goal to show an improvement in pain control, decrease in narcotic use, and increase in patient knowledge in the study group.
Detailed description
The use of opioid pain medications in surgical patients is contributing to an epidemic of opioid pain medication use. It is known that the quality of pain control after surgery is a large factor of the patient's perception of their experience. However, little research has been done to improve pain control in plastic surgery patients. To the investigators knowledge, no study has yet looked at education of breast surgery patients to improve pain experience. The study goal is to survey breast surgery patients in the Plastic Surgery department before and after surgery to evaluate the participants experience with pain and pain medications. Half of the participants in the study will be randomized to receive an information sheet about pain control at the participants pre-operative appointment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- All study participants received a study folder with information about the study and consent; the instrument was included in this folder for the intervention group. The control group received standard of care, including standard patient counseling from the surgical teams. In conjunction with oncologic psychology and plastic surgery, an instrument was developed to be provided as a single-paged paper handout to the intervention group. The instrument included information about expectations for pain control, information about the pain scale, and examples of opioid and adjunct medications which may be used as part of a multi-modal approach to pain control during the perioperative period.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: ControlThe control group received standard of care, including standard patient counseling from the surgical teams. |
| Intervention | Experimental | Behavioral: Educational handout instrumentIn conjunction with oncologic psychology and plastic surgery, an instrument was developed to be provided as a single-paged paper handout to the intervention group. The instrument included information about expectations for pain control, information about the pain scale, and examples of opioid and adjunct medications which may be used as part of a multi-modal approach to pain control during the perioperative period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female patients presenting for the first stage of breast reconstruction using tissue expanders
- Patients 18 years of age and older
Key exclusion criteria (4 listed)
- Male patients
- Patients under age 18
- Patients who have had previous breast reconstruction or tissue expansion
- Patients who are not able to read English will be excluded from this study as the study materials will be in written English
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 |
|---|---|---|
| Educational handout instrumentThe handout was single-paged (front and back), and was titled Pain After Surgery: What to Expect. The handout starts with information on rating pain and expectations for control of pain, not complete absence of pain, after surgery. Mutli-modal approach to pain control is then discussed, including pharmacologic and non-pharmacologic methods that may be used for pain control by the perioperative team and postoperatively. | Behavioural | Intervention |
| ControlStandard patient counseling | Behavioural | Control |
Primary outcome
Opioid consumption
Time frame: 1-2 weeks
Opioid consumption will be calculated from patient report of remaining narcotics at the postoperative appointment and the total opioid amount prescribed, from the medical record.
1 secondary outcome
Pain control: survey
Time frame: 1-2 weeks
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 28 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Richard Korentager, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational handout instrument in people with Opioid Use and Pain, Postoperative, run by University of Kansas Medical Center at 1 site in United States.
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 4 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 28 Sep 2020. 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 United States. 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.
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?
Opioid consumption (time frame: 1-2 weeks). 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 28 Sep 2020.