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Completed

NCT Number: NCT04058938

Pain in Breast Surgery Intervention

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Control

Behavioral

Standard patient counseling

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Aug 16, 2019
Registry last updated
Sep 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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