Pain in Breast Surgery Intervention
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|ClinicalTrials.gov Identifier: NCT04058938|
Recruitment Status : Completed
First Posted : August 16, 2019
Last Update Posted : September 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Opioid Use Pain, Postoperative||Behavioral: Educational handout instrument Behavioral: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Participant, Care Provider, Investigator)|
|Masking Description:||Study participants were not informed of randomization, and providers involved in patient care, consent, and postoperative questionnaire administration were blinded.|
|Official Title:||A Randomized Control Trial of Patient Education on Pain Control in Breast Surgery|
|Actual Study Start Date :||March 1, 2018|
|Actual Primary Completion Date :||May 1, 2019|
|Actual Study Completion Date :||March 1, 2020|
Active Comparator: Control
The control group received standard of care, including standard patient counseling from the surgical teams.
Standard patient counseling
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.
Behavioral: Educational handout instrument
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.
- 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.
- Pain control: survey [ Time Frame: 1-2 weeks ]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.
- Patient knowledge of pain control [ Time Frame: 1-2 weeks. ]Patient reported knowledge of pain control will be collected on the preoperative and postoperative survey. Patients will be asked to circle yes or no to feeling like the participant had enough information about pain control and about surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058938
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Richard Korentager, MD||University of Kansas Medical Center|