This REMAP Periop ERP domain study falls under the Periop Core Protocol, which compares the different recommended strategies for enhancing recovery through the use of various standard of care treatments before, during and after surgery in all patients with elective surgical encounters at UPMC who meet eligibility criteria. The ERP domain seeks to enhance recovery by optimizing strategies of perioperative care through evaluating combinations of perioperative treatment, which consists of preoperative, intraoperative and postoperative care. Optimal combinations of perioperative care will be generated and analyzed to determine the best outcomes for patients as defined by reduction in hospital free days, reduction in postoperative nausea and vomiting, and improved pain control.
The Periop Core Protocol is an administration structure designed to provide appropriate management of all aspects of the study, taking into account multiple factors including representation from clinics and hospitals that are participating in the trial, availability of skills and expertise related to trial conduct and statistical analysis, and content knowledge regarding acute illness, elective surgery, and the interventions that are being evaluated. Eligible patients will be randomized to a recommended set of standard of care treatments related to their surgery to identify those that improve outcomes as defined by hospital free days at 30 days from the date of the surgical encounter. The administration model is designed to provide effective operational and strategic management of the REMAP that operates in multiple UPMC facilities, is supported by multiple funding bodies and sponsors, and will evolve with addition of domains and interventions that are being evaluated. The ERP domain under the Periop Core Protocol will evaluate the varying recommended combinations of perioperative treatments, in hopes to determine the optimal strategies for perioperative care based on surgery type and patient specific factors. In this study, patient care components within the preoperative, perioperative, and postoperative domains will be randomized with a machine learning REMAP technique. Optimal strategies combining the entire perioperative process will be analyzed that determine best outcomes for patients including hospital free days, reductions in postoperative nausea and vomiting, and improved pain control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,977
This randomized group will receive a neuraxial morphine injection (intrathecal morphine/hydromorphone).
This randomized group will receive regional technique analgesia with sodium channel nerve blockade pharmacotherapy (ie nerve block)
This randomized group will receive 8 mg of perphenazine orally preoperatively.
This randomized group will receive 40 mg of aprepitant orally preoperatively.
This randomized group will receive 25 mg of dimenhydrinate orally preoperatively.
This randomized group will receive 4 mg of ondansetron orally.
This randomized group will receive 4-5 mg of dexamethasone intravenously.
This randomized group will receive regional technique analgesia with sodium channel nerve blockade pharmacotherapy (ie nerve block)
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
UPMC Passavant
Pittsburgh, Pennsylvania, United States
30 day hospital free days
The primary endpoint for this domain is the REMAP Periop primary outcome of hospital free days at 30 days after the elective surgical encounter.
Time frame: Day 0 - Day 30
Change in postoperative nausea and vomiting (PONV) by measurement incidences of emesis within 24 hours post surgery
Change in number of incidences of emesis 24 hours post surgery
Time frame: 0 - 24 hours surgery
Change in the rate of postoperative opioid use by measurement of oral morphine equivalents (OME) postoperative day 0 to postoperative day 1
Change in the rate (mg/day) of Oral Morphine Equivalents administered
Time frame: Day 0 - Day 1
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