ERAS Protocols in Breast Conserving Surgery

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer; Postoperative Recovery

• Registration Number: NCT06938581
• Lead Sponsor: University of Nebraska

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.

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 Timeline

• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-14
• Study First Posted: 2025-04-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-25
• Study Start: 2025-06
• Primary Completion: 2028-12
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 260

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With Opioid Prescriptions Within 7 Days of Surgery	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	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).

Secondary Outcome Measures

Name	Time	Method
Use of Anti-emetic Medication in Post-anesthesia Care Unit	Within 48 hours post-surgery	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.
Post-anesthesia Care Unit Length of Stay	Within 48 hours post-surgery	The duration of time in minutes from arrival in the post-anesthesia care unit (PACU) to discharge home will be recorded.

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States