Recruiting

ERAS Protocols

Sponsor:

University of Nebraska

Code:

NCT06938581

Conditions

Breast Cancer

Postoperative Recovery

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

ERAS Protocol

Standard Perioperative Care

Study Details

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

Study ID

NCT06938581

Start date

Jul 11, 2025

Status verified date

Jul, 2025

Completion date

Feb, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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 Design

Enrollment

260 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

ERAS Protocol

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 Care

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.

Primary outcome measure

  • Proportion of Participants With Opioid Prescriptions Within 7 Days of Surgery [ Time Frame: Within 7 days post-surgery ]
  • Immediate Post-operative Pain Score [ Time Frame: Within 24 hours post-surgery ]

Central Contacts and Locations

Central contacts

Juan A Santamaria, MD

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

Rubayat I Khan, PhD

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

Locations

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Rubayat I Khan, PhD

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

Taylor A Johnson, MA

402-559-5669taylora.johnson@unmc.edu

Principal Investigator:

Juan A Santamaria, MD

More Information

Sponsor

University of Nebraska

Last update posted

May 19, 2026

Last verified

Jul, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-05-19.