RecruitingNot Applicable

ERAS Protocols in Breast Conserving Surgery

United States260 participantsStarted 2025-07-11

Plain-language summary

Enhanced Recovery After Surgery (ERAS) protocols have been of increasing interest in the surgical community for decades. The emphasis has been development of protocols to maximize pain control post-operatively without the use of opioids. While this approach has been studied extensively in the oncology surgery literature, little data exists on the utility of ERAS protocols in the setting of breast conserving surgery (BCS), which is a type of surgery to remove breast cancer while saving as much of the breast as possible. The purpose of this study is to determine the utility of implementing ERAS protocols in breast cancer patients undergoing breast conserving surgery. Study participants will be randomized to either ERAS protocol or standard peri-operative care without ERAS. The study will assess the how many opioid prescriptions are given in the first week after surgery and how much pain participants report right after surgery. Investigators will also look at how long participants stay in the recovery room and if medicine for nausea is needed.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Participants With Opioid Prescriptions Within 7 Days of Surgery

Timeframe: Within 7 days post-surgery

Immediate Post-operative Pain Score

Timeframe: Within 24 hours post-surgery

Trial details

NCT IDNCT06938581

SponsorUniversity of Nebraska

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01

Contact for this trial

Juan A Santamaria, MD

402-559-7272 juan.santamaria@unmc.edu

View on ClinicalTrials.gov More Breast Cancer trials