ERAS Protocols in Breast Conserving Surgery

This study is looking at whether a special recovery plan called ERAS (Enhanced Recovery After Surgery) helps participants who are having breast conserving surgery, which is a type of surgery to remove breast cancer while saving as much of the breast as possible. ERAS includes taking certain medicines and drinks before surgery to help with pain and recovery. Investigators want to see if using ERAS leads to fewer opioid pain prescriptions and less pain right after surgery compared to the usual care. Participants will be randomly assigned to either the ERAS plan or the usual care. Investigators will check 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.

This is a single-institution, randomized control . The study aims to enroll 260 patients who are undergoing breast conserving surgery (lumpectomy with sentinel lymph node biopsy) for cT1-T3 N0 breast cancer. Participants will be randomly assigned to either the ERAS protocol or standard peri-operative care without ERAS.

ERAS protocol:

Day before surgery: Oral carbohydrate drink (evening), acetaminophen 1000mg (evening), and celecoxib 200mg (morning and evening).

Morning of surgery: Oral carbohydrate drink (2-4 hours before surgery), celecoxib 200mg, and acetaminophen 1000mg.

Participants in the standard care arm will receive routine peri-operative instructions without ERAS interventions.

The primary study objects are to determine the proportion of participants receiving an opioid prescription within 7 days after surgery and to evaluate the participant-reported pain levels in the post-anesthesia care unit (PACU) using the Numerical Rating Scale (NRS). The secondary objects are to determine the length of stay in PACU and the wse of anti-emetic medications in PACU.

The study uses a non-inferiority design to test if standard care without ERAS is not significantly worse than ERAS for opioid use and pain scores. The sample size of 260 participants ensures enough power to detect differences in the primary outcomes. Data collected will include opioid prescriptions, pain scores, PACU stay duration, and anti-emetic use. Statistical comparisons will look at proportions and averages between the ERAS and standard care groups, with additional analysis based on tumor size.

Eligibility Criteria:
Inclusion Criteria:

* Males or females age \<19 years old
* 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