A Randomized Control Trial of Patient Education on Pain Control in Breast Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Opioid consumption
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Control
The control group received standard of care, including standard patient counseling from the surgical teams.
Intervention: Control (Behavioral)
Intervention
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.
Intervention: Educational handout instrument (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Pain control: survey(1-2 weeks)
Investigators
Katie Egan
Plastic Surgery Resident
University of Kansas Medical Center