Enhanced Recovery (ERAS) care for adults having lumpectomy with sentinel lymph node biopsy
Official title: The Utility of Enhanced Recovery After Surgery (ERAS) Protocols in Breast Conserving Surgery: A Randomized Control Trial
Run by University of Nebraska · NCT06938581 · Data updated 2026-11-12
This will test whether an ERAS medication-and-carbohydrate care plan can reduce opioid prescriptions and immediate post-surgery pain for adults undergoing lumpectomy with sentinel lymph node biopsy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 260 (estimated) |
| Sponsor | University of Nebraska Academic / other |
| Locations | 1 site (Omaha, Nebraska) |
| Status | Recruiting |
| Started | July 11, 2025 |
| Main results expected | January 2029 |
| Study ends | February 2029 |
| Registry record updated | October 8, 2026 |
| Trial ID | NCT06938581 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 19 or older with histologically confirmed cT1-T3 N0 breast cancer planning lumpectomy with sentinel lymph node biopsy who can swallow and retain oral carbohydrate drinks and are not already on chronic opioids are ideal candidates.
✕Probably not a fit
Patients who are pregnant, have cT4 or node-positive or metastatic disease, require mastectomy or other excluded procedures, have contraindications to ERAS components, are taking opioids for other indications, or have substance use disorder may not benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized Phase 2 study will enroll about 260 adults with cT1-T3 N0 breast cancer undergoing breast-conserving surgery (lumpectomy with sentinel lymph node biopsy) and assign them to either an ERAS protocol or standard perioperative care. The ERAS arm includes preoperative oral carbohydrate drinks, scheduled acetaminophen and celecoxib before surgery and immediately afterward, while the control arm receives routine perioperative instructions without those interventions. Primary outcomes are the proportion of participants receiving an opioid prescription within 7 days after surgery and participant-reported pain in the post-anesthesia care unit (PACU) using the Numerical Rating Scale. Secondary outcomes include PACU length of stay and use of anti-emetic medications in PACU, and all procedures are conducted at the University of Nebraska Medical Center.
Why it matters
Potential benefit: If successful, this approach could lower the need for opioid prescriptions after lumpectomy and reduce immediate postoperative pain and PACU needs.
How similar studies have gone: ERAS approaches have reduced opioid use and improved recovery in many other surgical specialties and oncology procedures, but there is limited published data specifically in breast-conserving surgery.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of Nebraska Medical Center
Omaha, Nebraska, United States Recruiting
Study contacts
- Principal investigator: Juan A Santamaria, MD — University of Nebraska
- Study coordinator: Juan A Santamaria, MD
- Email: juan.santamaria@unmc.edu
- Phone: 402-559-7272
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.