NCT06938581 · University of Nebraska
ERAS Protocols in Breast Conserving Surgery
(ERAS)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
ERAS Protocol
The ERAS protocol consists of: * Day before surgery: Oral carbohydrate drink (evening), Acetaminophen 1000mg (evening), Celecoxib 200mg (morning and evening) * Morning of surgery: Oral carbohydrate drink (2-4 hours before surgery), Celecoxib 200mg, Acetaminophen 1000mg Additionally, optional perioperative medications (Acetaminophen, Scopolamine, Dexamethasone, Ondansetron) may be given as needed.
OTHER
Standard Perioperative Care
Standard perioperative care without ERAS protocol components. Includes routine preoperative instructions and omission of oral carbohydrate drink, celecoxib, and preoperative acetaminophen. Optional perioperative medications (Acetaminophen, Scopolamine, Dexamethasone, Ondansetron) may be given as needed.
Primary outcome measures
Proportion of Participants With Opioid Prescriptions Within 7 Days of Surgery
Time frame: Within 7 days post-surgery
The percentage of participants who receive an opioid prescription from the surgery team within 7 days after surgery will be determined from the documented electronic medical record.
Immediate Post-operative Pain Score
Time frame: Within 24 hours post-surgery
Participant reported pain level in the post-anesthesia care unit (PACU) using the Numerical Rating Scale (NRS) will be assessed. Scoring is from 0 (no pain) to 10 (worst pain imaginable).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Omaha, Nebraska
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 19, 2026 · Source of record for eligibility and locations