ERAS Protocols in Breast Conserving Surgery (ERAS)
The Utility of Enhanced Recovery After Surgery (ERAS) Protocols in Breast Conserving Surgery: A Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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). The study aims to enroll 260 participants 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.
The ERAS protocol is comprised of celecoxib 200mg, morning and evening, and an oral carbohydrate drink and acetaminophen 1000mg in the evening the day before surgery and an oral carbohydrate drink (2-4 hours before surgery), celecoxib 200mg and acetaminophen 1000mg the morning of surgery. Participants in the standard care arm will receive routine peri-operative instructions without ERAS interventions. The study's primary objectives 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 objectives are to determine the length of stay in PACU and the use 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. Statistical comparisons will look at proportions and averages between the ERAS and standard care groups, with additional analysis based on tumor size.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rubayat I Khan, PhD
- Phone Number: 402-559-2983
- Email: rubayat.khan@unmc.edu
Study Contact Backup
- Name: Juan A Santamaria, MD
- Phone Number: 402-559-7272
- Email: juan.santamaria@unmc.edu
Study Locations
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Nebraska
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Omaha, Nebraska, United States, 68198
- Recruiting
- University of Nebraska Medical Center
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Contact:
- Rubayat I Khan, PhD
- Phone Number: 402-559-2983
- Email: rubayat.khan@unmc.edu
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Contact:
- Taylor A Johnson, MA
- Phone Number: 402-559-5669
- Email: taylora.johnson@unmc.edu
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Principal Investigator:
- Juan A Santamaria, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: ERAS Protocol Arm
Participants will receive the Enhanced Recovery After Surgery (ERAS) protocol as part of peri-operative care. The ERAS protocol includes: (day before surgery) oral carbohydrate drink in the evening, Acetaminophen 1000mg in the evening, Celecoxib 200mg in the morning and evening and (morning of surgery) oral carbohydrate drink 2-4 hours before surgery, Celecoxib 200mg, Acetaminophen 1000mg. Additionally, peri-operative medications such as Acetaminophen, Scopolamine, Dexamethasone, and Ondansetron may be given as needed at the discretion of the surgery and anesthesia teams. |
The ERAS protocol consists of:
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Experimental: Standard Care Arm
Participants will receive standard peri-operative care without the Enhanced Recovery After Surgery (ERAS) protocol.
This includes routine preoperative instructions and omission of the ERAS-specific interventions (oral carbohydrate drink, Celecoxib, and preoperative Acetaminophen).
Perioperative medications such as Acetaminophen, Scopolamine, Dexamethasone, and Ondansetron may be given as needed at the discretion of the surgery and anesthesia teams.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Participants With Opioid Prescriptions Within 7 Days of Surgery
Time Frame: Within 7 days post-surgery
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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.
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Within 7 days post-surgery
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Immediate Post-operative Pain Score
Time Frame: Within 24 hours post-surgery
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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).
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Within 24 hours post-surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Post-anesthesia Care Unit Length of Stay
Time Frame: Within 48 hours post-surgery
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The duration of time in minutes from arrival in the post-anesthesia care unit (PACU) to discharge home will be recorded.
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Within 48 hours post-surgery
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Use of Anti-emetic Medication in Post-anesthesia Care Unit
Time Frame: Within 48 hours post-surgery
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The proportion of participants who receive any anti-emetic medication (such as ondansetron, prochlorperazine, haloperidol, or metoclopramide) from arrival in the PACU to discharge home will be determined.
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Within 48 hours post-surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Juan A Santamaria, MD, University of Nebraska
Publications and helpful links
General Publications
- Cyr AE. Underutilization of Enhanced Recovery After Surgery (ERAS) in Breast Surgery: An Opportunity to Reduce Opioid Usage. Ann Surg Oncol. 2020 Apr;27(4):966-968. doi: 10.1245/s10434-020-08198-y. Epub 2020 Jan 23. No abstract available.
- Chiu C, Aleshi P, Esserman LJ, Inglis-Arkell C, Yap E, Whitlock EL, Harbell MW. Improved analgesia and reduced post-operative nausea and vomiting after implementation of an enhanced recovery after surgery (ERAS) pathway for total mastectomy. BMC Anesthesiol. 2018 Apr 16;18(1):41. doi: 10.1186/s12871-018-0505-9.
- Batdorf NJ, Lemaine V, Lovely JK, Ballman KV, Goede WJ, Martinez-Jorge J, Booth-Kowalczyk AL, Grubbs PL, Bungum LD, Saint-Cyr M. Enhanced recovery after surgery in microvascular breast reconstruction. J Plast Reconstr Aesthet Surg. 2015 Mar;68(3):395-402. doi: 10.1016/j.bjps.2014.11.014. Epub 2014 Nov 21.
- Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0132-25-FB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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