Pain in Breast Surgery Intervention

Not Applicable

Completed

• Conditions: Pain, Postoperative; Opioid Use
• Interventions: Behavioral: Control; Behavioral: Educational handout instrument

• Registration Number: NCT04058938
• Lead Sponsor: University of Kansas Medical Center

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 Timeline

• Study Start: 2018-03-01
• Primary Completion: 2019-05-01
• Study First Submitted: 2019-08-14
• Study First Submitted QC: 2019-08-15
• Study First Posted: 2019-08-16
• Study Completion: 2020-03-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-25
• Last Update Posted: 2020-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	The control group received standard of care, including standard patient counseling from the surgical teams.
Intervention	Educational handout instrument	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 Outcome Measures

Name	Time	Method
Opioid consumption	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 Outcome Measures

Name	Time	Method
Pain control: survey	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.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States