ERAS Protocols in Breast Conserving Surgery

NCT06938581 | Recruiting Phase 2 DMC

• 1 other identifier: 0132-25-FB
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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. 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

Breast Cancer; Postoperative Recovery

Keywords

Eras; Opioid Use; Pain Management; Breast Conserving Surgery; Sentinel Lymph Node Biopsy; Perioperative Care

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Within 24 hours post-surgery

Secondary Outcomes (2)

• Post-anesthesia Care Unit Length of Stay

  Within 48 hours post-surgery

• Use of Anti-emetic Medication in Post-anesthesia Care Unit

  Within 48 hours post-surgery

Study Arms (2)

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.

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.

Other: Standard Perioperative Care

Interventions

ERAS Protocol OTHER

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.

ERAS Protocol Arm

Standard Perioperative Care OTHER

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.

Standard Care Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 31974707 BACKGROUND

• 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.

  PMID: 29661153 BACKGROUND

• 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.

  PMID: 28403427 BACKGROUND

• 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.

  PMID: 25488326 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Agnosia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan A Santamaria, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan A Santamaria, MD

CONTACT

402-559-7272; juan.santamaria@unmc.edu

Rubayat I Khan, PhD

CONTACT

402-559-2983; rubayat.khan@unmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: July 11, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: April 24, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)