This clinical trial compares the enhanced recovery after surgery (ERAS) protocol versus no ERAS protocol in reducing prescribed opioids for pain control after surgery in patients with breast cancer undergoing breast conserving surgery with lumpectomy and sentinel lymph node biopsy. ERAS protocols have been of increasing interest in the surgical community for decades. An emphasis on opioid-sparing pain management has led to the development of protocols to maximize pain control after surgery without the use of opioids. This approach has been extensively studied in cancer surgery, however, very little data exists in the setting of breast conserving surgery. Currently, standard of care includes implementing ERAS protocol for patients undergoing breast conserving surgery, despite lack of data supporting its necessity. Removing the ERAS protocol for patients undergoing breast conserving surgery may prevent unnecessary administration of medications while also not increasing the number of opioids prescribed to patients compared to utilizing the ERAS protocol.
Additional locations may be listed on ClinicalTrials.gov for NCT06938581.
Locations matching your search criteria
United States
Nebraska
Omaha
University of Nebraska Medical CenterStatus: Active
Contact: Juan Antonio Santamaria
Phone: 402-559-7272
PRIMARY OBJECTIVES:
I. To evaluate the absence of enhanced recovery after surgery (ERAS) protocol on opioid prescription rates following breast conserving surgery (lumpectomy and sentinel node biopsy).
II. To evaluate patient-reported pain levels in the immediate post operative period.
SECONDARY OBJECTIVES:
I. To evaluate post operative recovery time.
II. To evaluate post operative nausea and vomiting in the immediate post operative period.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive standard care with no ERAS protocol prior to and on the day of scheduled lumpectomy/sentinel lymph node biopsy. Patients may undergo additional diagnostic imaging on study.
ARM B: Patients receive ERAS protocol consisting of the following: 1) carbohydrate drink orally (PO) the night before surgery and 2-4 hours prior to surgery, 2) acetaminophen PO the night before surgery and in the morning prior to surgery, and 3) celecoxib PO in the morning and night the day before surgery and in the morning prior to surgery. Patients may undergo additional diagnostic imaging on study.
After completion of study treatment, patients are followed up within 2 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Nebraska Medical Center
Principal InvestigatorJuan Antonio Santamaria