Underutilization of Enhanced Recovery After Surgery (ERAS) in Breast Surgery: An Opportunity to Reduce Opioid Usage.
Amy E Cyr
https://pubmed.ncbi.nlm.nih.gov/31974707Actively Recruiting
Phase Not Applicable
Age: 19Years +
All Genders
ID06938581
The Utility of Enhanced Recovery After Surgery (ERAS) Protocols in Breast Conserving Surgery A Randomized Control Trial
Led by University of Nebraska · Updated on 2026-05-19
260
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Enhanced Recovery After Surgery (ERAS) protocols in patients undergoing breast conserving surgery (BCS) for breast cancer. This study aims to determine whether ERAS protocols can reduce opioid prescriptions and pain after surgery compared to standard peri-operative care. Although ERAS has been studied in oncology surgery broadly, its benefit specifically in breast conserving surgery is not well documented. The study enrolls 260 participants diagnosed with early-stage breast cancer (cT1-T3 N0) undergoing lumpectomy with sentinel lymph node biopsy. Participants are randomly assigned to receive either the ERAS protocol or standard care. The ERAS protocol includes preoperative oral carbohydrate drinks, acetaminophen, and celecoxib given the day before and morning of surgery, while standard care follows routine peri-operative instructions without these interventions. Both groups may receive other medications during surgery as needed. Participants will be closely monitored for opioid prescription use within 7 days after surgery and their pain levels immediately following surgery using a numerical rating scale. Secondary measures include length of stay in the recovery room and use of anti-nausea medications. The study compares outcomes between the two groups to assess if standard care is not worse than ERAS. The total participation timeline covers the surgery day and the immediate postoperative recovery period up to 7 days.
CONDITIONS
Brief Title
ERAS Protocols in Breast Conserving Surgery
Who Can Participate
Age: 19Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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 and sentinel lymph node biopsy
- No prior definitive treatment or intervention
- Able to swallow and retain oral carbohydrate drinks and medication
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery and up to 48 hours post-surgery
Participants undergo breast conserving surgery (lumpectomy with sentinel lymph node biopsy) followed by immediate post-operative care. Participants in the ERAS protocol arm receive specific preoperative medications and carbohydrate drinks before surgery, while those in the standard care arm receive routine peri-operative instructions without these interventions. Additional peri-operative medications may be given as needed.
1 surgery visit and post-operative care during hospital stay
Post-operative Follow-up
Duration - Up to 7 days post-surgery
Participants are monitored for opioid use, pain levels, length of stay in post-anesthesia care unit, and use of anti-emetic medications within 7 days after surgery.
Approximately 1 follow-up visit within 7 days
Trial Site Locations
Total: 1 location
1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
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Research Team
J
Juan A Santamaria, MD
R
Rubayat I Khan, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
Improved analgesia and reduced post-operative nausea and vomiting after implementation of an enhanced recovery after surgery (ERAS) pathway for total mastectomy.
Catherine Chiu, Pedram Aleshi, Laura J Esserman...
https://pubmed.ncbi.nlm.nih.gov/29661153New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults.
Chad M Brummett, Jennifer F Waljee, Jenna Goesling...
https://pubmed.ncbi.nlm.nih.gov/28403427Enhanced recovery after surgery in microvascular breast reconstruction.
Niles J Batdorf, Valerie Lemaine, Jenna K Lovely...
https://pubmed.ncbi.nlm.nih.gov/25488326