RecruitingPhase 2NCT06938581

ERAS Protocols in Breast Conserving Surgery

The Utility of Enhanced Recovery After Surgery (ERAS) Protocols in Breast Conserving Surgery: A Randomized Control Trial

Sponsor

University of Nebraska

Enrollment

260 participants

Start Date

Jul 11, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Postoperative Recovery

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.

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating an 'enhanced recovery after surgery' (ERAS) protocol for breast cancer patients undergoing breast-conserving surgery (lumpectomy). ERAS protocols use a combination of strategies — like special nutrition drinks before surgery and optimized pain management — to help patients recover faster with fewer complications. **You may be eligible if...** - You are 19 or older - You have a confirmed breast cancer diagnosis from a core needle biopsy - You are scheduled for a lumpectomy (removing the tumor while keeping the breast) and sentinel lymph node biopsy - You have not had any prior breast cancer treatment - You are able to swallow drinks and take oral medications **You may NOT be eligible if...** - You are pregnant - You have a reason you cannot follow an ERAS protocol - You are having a mastectomy (full breast removal) instead of a lumpectomy - Your cancer is advanced (stage T4 or with significant lymph node spread or metastasis) - You are currently taking opioid pain medications or have a history of substance use disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERERAS 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.

OTHERStandard 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.

Locations(1)

University of Nebraska Medical Center

Omaha, Nebraska, United States

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NCT06938581

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