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Recruiting NCT06938581

ERAS Protocols in Breast Conserving Surgery

Trial Parameters

Condition Breast Cancer
Sponsor University of Nebraska
Study Type INTERVENTIONAL
Phase N/A
Enrollment 260
Sex ALL
Min Age 19 Years
Max Age N/A
Start Date 2025-07-11
Completion 2029-01
Interventions
ERAS ProtocolStandard Perioperative Care

Brief 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.

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

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