Pain in Breast Surgery Intervention

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Control Trial of Patient Education on Pain Control in Breast Surgery

Conditions
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Opioid Use, Pain, Postoperative

Intervention / Treatment
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* Behavioral: Educational handout instrument
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>The control group received standard of care, including standard patient counseling from the surgical teams. | Behavioral: Control<br>* Standard patient counseling<br>|
| Experimental: Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | 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. | 1-2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain control: survey | 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. | 1-2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid use, breast reconstruction, pain control, mastectomy