Pain in Breast Surgery Intervention

University of Kansas

Status: Completed

Conditions: Pain, Postoperative; Opioid Use

Treatments: Behavioral: Control; Behavioral: Educational handout instrument

Study type: Interventional

Funder types: Other

Identifiers

NCT04058938

00141330

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Control

Active Comparator group

Description:

The control group received standard of care, including standard patient counseling from the surgical teams.

Treatment:

Behavioral: Control

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Educational handout instrument