Pain in Breast Surgery Intervention

• ClinicalTrials.gov Identifier: NCT04058938
• Recruitment Status: Completed
• First Posted: August 16, 2019
• Last Update Posted: September 28, 2020
• Sponsor: University of Kansas Medical Center
• Information provided by (Responsible Party): Katie Egan, University of Kansas Medical Center

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.

Condition or disease	Intervention/treatment	Phase
Opioid Use; Pain, Postoperative	Behavioral: Educational handout instrument; Behavioral: Control	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (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.
• Primary Purpose: Prevention
• Official Title: A Randomized Control Trial of Patient Education on Pain Control in Breast Surgery
• Actual Study Start Date: March 1, 2018
• Actual Primary Completion Date: May 1, 2019
• Actual Study Completion Date: March 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Control; The control group received standard of care, including standard patient counseling from the surgical teams.	Behavioral: Control; Standard patient counseling
Experimental: 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.	Behavioral: Educational handout instrument; 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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Pain control: survey [ Time Frame: 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.

Other Outcome Measures:

1. Patient knowledge of pain control [ Time Frame: 1-2 weeks. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Patients must be female patients undergoing mastectomy and breast reconstruction to be eligible for the study.
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Kansas

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Sponsors and Collaborators

University of Kansas Medical Center

Investigators

• Principal Investigator: Richard Korentager, MD; University of Kansas Medical Center

More Information

• Responsible Party: Katie Egan, Plastic Surgery Resident, University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT04058938
• Other Study ID Numbers: 00141330
• First Posted: August 16, 2019
• Last Update Posted: September 28, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Katie Egan, University of Kansas Medical Center:

opioid use; breast reconstruction; pain control; mastectomy

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations