NCT06938581 ERAS Protocols in Breast Conserving Surgery
| NCT ID | NCT06938581 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nebraska |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2025-07-11 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 260 participants in total. It began in 2025-07-11 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Juan A Santamaria, MD
PRINCIPAL INVESTIGATOR
University of Nebraska
Frequently Asked Questions
Who can join the NCT06938581 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06938581 currently recruiting?
Yes, NCT06938581 is actively recruiting participants. Contact the research team at juan.santamaria@unmc.edu for enrollment information.
Where is the NCT06938581 trial being conducted?
This trial is being conducted at Omaha, United States.
Who is sponsoring the NCT06938581 clinical trial?
NCT06938581 is sponsored by University of Nebraska. The principal investigator is Juan A Santamaria, MD at University of Nebraska. The trial plans to enroll 260 participants.
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