The Utility of Enhanced Recovery After Surgery (ERAS) Protocols in Breast Conserving Surgery: A Randomized Control Trial
University of Nebraska
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.
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…
Eligibility
- Age range
- 19+ years
- Sex
- All
- Healthy volunteers
- No
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 p…
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.
Location
- University of Nebraska Medical CenterOmaha, Nebraska