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Pain in Breast Surgery Intervention

Primary Purpose

Opioid Use, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational handout instrument
Control
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid Use focused on measuring opioid use, breast reconstruction, pain control, mastectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 14, 2019
Last Updated
September 25, 2020
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04058938
Brief Title
Pain in Breast Surgery Intervention
Official Title
A Randomized Control Trial of Patient Education on Pain Control in Breast Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Pain, Postoperative
Keywords
opioid use, breast reconstruction, pain control, mastectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
Study participants were not informed of randomization, and providers involved in patient care, consent, and postoperative questionnaire administration were blinded.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control group received standard of care, including standard patient counseling from the surgical teams.
Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Educational handout instrument
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Standard patient counseling
Primary Outcome Measure Information:
Title
Opioid consumption
Description
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.
Time Frame
1-2 weeks
Secondary Outcome Measure Information:
Title
Pain control: survey
Description
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.
Time Frame
1-2 weeks
Other Pre-specified Outcome Measures:
Title
Patient knowledge of pain control
Description
Patient reported knowledge of pain control will be collected on the preoperative and postoperative survey. Patients will be asked to circle yes or no to feeling like the participant had enough information about pain control and about surgery.
Time Frame
1-2 weeks.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patients must be female patients undergoing mastectomy and breast reconstruction to be eligible for the study.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Korentager, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pain in Breast Surgery Intervention

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