Clinical trial NCT04058938: Pain in Breast Surgery Intervention
Official title: A Randomized Control Trial of Patient Education on Pain Control in Breast Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Pain, Postoperative
Keywords: opioid use
breast reconstruction
pain control
mastectomy
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Female patients presenting for the first stage of breast reconstruction using tissue expanders
* Patients 18 years of age and older

Exclusion Criteria:

* 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

Primary outcomes:
measure: Opioid consumption
timeFrame: 1-2 weeks
Secondary outcomes:
measure: Pain control: survey
timeFrame: 1-2 weeks
Other outcomes:
measure: Patient knowledge of pain control
timeFrame: 1-2 weeks.
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Richard Korentager, MD
role: PRINCIPAL_INVESTIGATOR
References: