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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
United States
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
Contact Information
Primary
Juan A Santamaria, MD
juan.santamaria@unmc.edu
402-559-7272
Backup
Rubayat I Khan, PhD
rubayat.khan@unmc.edu
402-559-2983
Time Frame
Start Date: 2025-07-11
Estimated Completion Date: 2029-02
Participants
Target number of participants: 260
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Nebraska

This content was sourced from clinicaltrials.gov