Clinical trial · Interventional
ERAS Protocols in Breast Conserving Surgery
The Utility of Enhanced Recovery After Surgery (ERAS) Protocols in Breast Conserving Surgery: A Randomized Control Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Postoperative Recovery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERAS Protocol | Other | — | UNRESOLVED |
| Standard Perioperative Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ERAS Protocol Arm
- description
- 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.
- interventionNames
- Other: ERAS Protocol
- type
- EXPERIMENTAL
- label
- Standard Care Arm
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDCyr 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. PMID 31974707
- BACKGROUNDChiu 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. PMID 29661153
- BACKGROUNDBrummett 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. PMID 28403427
- BACKGROUNDBatdorf 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. PMID 25488326