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/31974707/Actively Recruiting
Led by University of Nebraska · Updated on 2026-05-19
260
Participants Needed
1
Research Sites
4 weeks
Total Duration
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
ERAS Protocols in Breast Conserving Surgery
J
Juan A Santamaria, MD
R
Rubayat I Khan, PhD
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University of Nebraska
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | ERAS Protocol | Standard Care |
|---|---|---|
| What it is | A defined Enhanced Recovery After Surgery (ERAS) protocol including preoperative oral carbohydrate drinks, acetaminophen, and celecoxib administered before breast conserving surgery. | Institutional or routine standard perioperative care, without the added ERAS protocol elements, as typically provided before breast conserving surgery. |
| Role in trial | Investigational arm to assess whether ERAS protocols can reduce opioid prescriptions and improve pain and recovery outcomes following breast conserving surgery. | Comparator arm reflecting current perioperative practices, used to measure outcomes against ERAS protocol in the same population. |
| Primary use | To reduce the need for opioid prescriptions after surgery and improve post-operative pain and recovery for patients undergoing breast conserving surgery. | To provide usual perioperative management as practiced outside the study interventions, including pain management based on institutional policies. |
| How it is given or performed | Oral carbohydrate drinks, acetaminophen, and celecoxib are given at set times before surgery, with optional perioperative medications as needed. | Participants receive routine preoperative instructions without carbohydrate drinks or protocolized celecoxib or acetaminophen; antiemetics and other medications may be used per normal practice. |
| Evidence status | Multiple external studies have shown that ERAS protocols in breast surgery can reduce opioid use, improve pain control, and shorten hospital stays compared to traditional care. | Traditional care has been the main approach but is associated with higher rates of opioid prescribing and potentially longer recovery compared to ERAS-based protocols. |
| Important limitations | The ERAS protocol's effectiveness and safety in a broader population is still being evaluated, and differences in institutional implementation may affect outcomes. Not all patients are eligible due to possible medication contraindications. | Standard perioperative care does not use structured protocols for opioid reduction or enhanced recovery, and may result in inconsistent outcomes. Persistent opioid use is a known concern following surgery with conventional care. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/29661153/University of Nebraska
Lead Sponsor