ERAS Protocols in Breast Conserving Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Nebraska
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
ERAS Protocol
Other interventionThe 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
Other interventionStandard 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.
Treatment groups
260 Participants
are divided into 2 treatment groupsGroup A: ERAS Protocol ArmActive comparator 1 intervention
Group B: Standard Care ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Participants With Opioid Prescriptions Within 7 Days of 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.
Time frame
Within 7 days post-surgery2
Immediate Post-operative Pain Score
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).
Time frame
Within 24 hours post-surgerySecondary outcomes
1
Post-anesthesia Care Unit Length of Stay
The duration of time in minutes from arrival in the post-anesthesia care unit (PACU) to discharge home will be recorded.
Time frame
Within 48 hours post-surgery2
Use of Anti-emetic Medication in Post-anesthesia Care Unit
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.
Time frame
Within 48 hours post-surgerySponsors and contacts
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Source ClinicalTrials.gov