Breast CancerERASNCT06938581
ERAS Protocols in Breast Conserving Surgery
A study testing ERAS Protocol and Standard Perioperative Care in people with Breast Cancer and Postoperative Recovery, run by University of Nebraska at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Breast Cancer, Postoperative Recovery
- What is being tested?
- ERAS Protocol and Standard Perioperative Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2025to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
IIT Office, 402-559-4596, IITOffice@unmc.edu
A
About this study
Official title: The Utility of Enhanced Recovery After Surgery (ERAS) Protocols in Breast Conserving Surgery: A Randomized Control Trial
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.
Read the 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.
- Conditions
- Breast Cancer, Postoperative Recovery
- Being tested
- ERAS Protocol, Standard Perioperative Care
- Keywords
- Eras, Opioid Use, Pain Management, Breast Conserving Surgery, Sentinel Lymph Node Biopsy, Perioperative Care
- Medical subject headings
- Breast Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS ProtocolOther
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.
Standard Perioperative CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ERAS Protocol Arm | Active comparator | 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. Receives: Other: ERAS Protocol |
| Standard Care Arm | Experimental | 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. Receives: Other: Standard Perioperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Opioid Prescriptions Within 7 Days of 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.
Measured: Within 7 days post-surgery
Immediate Post-operative Pain Score
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).
Measured: Within 24 hours post-surgery
Secondary outcomes (2)
Post-anesthesia Care Unit Length of Stay
The duration of time in minutes from arrival in the post-anesthesia care unit (PACU) to discharge home will be recorded.
Measured: Within 48 hours post-surgery
Use of Anti-emetic Medication in Post-anesthesia Care Unit
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.
Measured: Within 48 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start11 Jul 2025
- Primary completionJan 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan A Santamaria, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938581
- Sponsor's protocol ID
- 0132-25-FB
- Acronym
- ERAS
- Status last verified
- Oct 2026
- First submitted
- 14 Apr 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31974707Chiu 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.
PubMed 29661153Brummett 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.
PubMed 28403427Batdorf 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.
PubMed 25488326
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Enhanced Recovery After Surgery (ERAS) Protocols in Breast Conserving Surgery: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06938581
- Acronym / sponsor ID
- ERAS / 0132-25-FB
- Conditions
- Breast Cancer, Postoperative Recovery
- Keywords
- Eras, Opioid Use, Pain Management, Breast Conserving Surgery, Sentinel Lymph Node Biopsy, Perioperative Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS Protocol Arm | Active comparator | Other: ERAS ProtocolParticipants 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. |
| Standard Care Arm | Experimental | Other: Standard Perioperative CareParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS ProtocolThe 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 | ERAS Protocol Arm |
| Standard Perioperative CareStandard 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. | Other | Standard Care Arm |
Primary outcome
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).
2 secondary outcomes
Post-anesthesia Care Unit Length of Stay
Time frame: Within 48 hours post-surgery
Use of Anti-emetic Medication in Post-anesthesia Care Unit
Time frame: Within 48 hours post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 31974707Cyr 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.
- Background: PubMed 29661153Chiu 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.
- Background: PubMed 28403427Brummett 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.
- Background: PubMed 25488326Batdorf 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan A Santamaria, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS Protocol and Standard Perioperative Care in people with Breast Cancer and Postoperative Recovery, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan A Santamaria, MD (402-559-7272, juan.santamaria@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Opioid Prescriptions Within 7 Days of Surgery (time frame: Within 7 days post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06938581, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.