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Search / Trial NCT06938581

ERAS Protocols in Breast Conserving Surgery

Launched by UNIVERSITY OF NEBRASKA · Apr 14, 2025

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

Eras Opioid Use Pain Management Breast Conserving Surgery Sentinel Lymph Node Biopsy Perioperative Care

ClinConnect Summary

This clinical trial is exploring a special recovery plan called ERAS, or Enhanced Recovery After Surgery, to see if it helps people recovering from breast conserving surgery, which is a procedure that aims to remove breast cancer while preserving as much of the breast as possible. The ERAS plan involves specific medications and drinks taken before surgery to help with pain and recovery. Researchers want to find out if this approach leads to fewer prescriptions for opioid pain medications and less pain immediately after surgery compared to standard care. Participants will be randomly assigned to either follow the ERAS plan or receive usual care, and their pain levels, opioid prescriptions, and recovery experiences will be monitored.

To be eligible for this trial, participants must be aged 19 or older and have a confirmed diagnosis of breast cancer that hasn't spread. They should be scheduled for breast conserving surgery, which includes a lumpectomy and sentinel lymph node biopsy. Candidates must also be able to swallow and keep down specific drinks and medications. It’s important to know that this trial is not open for recruitment yet, and there are some conditions that would exclude individuals, like being pregnant or having certain health issues. Participants can expect to actively contribute to understanding better recovery methods after breast surgery while being closely monitored for their pain management and overall recovery experience.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Males or females 19 years of age or older
  • Able to provide study-specific informed consent
  • Histologic confirmation of breast cancer on core needle biopsy
  • Clinical or radiographic cT1-T3 N0 disease
  • Undergoing breast conserving surgery with lumpectomy \& sentinel lymph node biopsy
  • No prior definitive treatment or intervention
  • Able to swallow and retain oral carbohydrate drinks and medication
  • Exclusion Criteria:
  • Pregnant
  • Contraindications to ERAS protocol components
  • Undergoing lumpectomy without sentinel lymph node biopsy, mastectomy, or other specified procedures
  • Diagnosed with cT4 or N1-3 disease
  • Metastatic disease at presentation
  • Taking opioid pain medications for other indications
  • History of substance use disorder
  • Any condition where ERAS could compromise safety

About University Of Nebraska

The University of Nebraska is a leading academic institution dedicated to advancing healthcare through innovative research and clinical trials. With a strong commitment to improving patient outcomes and fostering scientific discovery, the university collaborates with various healthcare professionals and researchers to conduct rigorous clinical studies across diverse medical fields. The institution prioritizes ethical standards and patient safety while striving to translate research findings into practical solutions that enhance medical practices and contribute to the overall well-being of the community.

Locations

Omaha, Nebraska, United States

Patients applied

0 patients applied

Trial Officials

Juan A Santamaria, MD

Principal Investigator

University of Nebraska

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported