Pain in Breast Surgery Intervention

NCT04058938 | Completed

• 1 other identifier: 00141330
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use; Pain, Postoperative

Keywords

opioid use; breast reconstruction; pain control; mastectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain control: survey

  1-2 weeks

Other Outcomes (1)

• Patient knowledge of pain control

  1-2 weeks.

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Behavioral: Control

Intervention

EXPERIMENTAL

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

Interventions

Educational handout instrument BEHAVIORAL

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

Control BEHAVIORAL

Standard patient counseling

Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients must be female patients undergoing mastectomy and breast reconstruction to be eligible for the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients presenting for the first stage of breast reconstruction using tissue expanders
• Patients 18 years of age and older

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Richard Korentager, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Study participants were not informed of randomization, and providers involved in patient care, consent, and postoperative questionnaire administration were blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic Surgery Resident

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 16, 2019
• Study Start: March 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: March 1, 2020
• Last Updated: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)