Perioperative Optimization
Conditions
Keywords
perioperative, enhanced recovery, patient-directed care, randomized embedded multifactorial adaptive platform, REMAP, ERP, 90-day hospital free days, length of stay, perioperative optimization, oral morphine equivalents, postoperative nausea and vomiting, readmission
Brief summary
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.
Detailed description
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.
Interventions
This randomized group will receive a neuraxial morphine injection (intrathecal morphine/hydromorphone).
DRUGRegional Block 1: Paravertebral
This randomized group will receive regional technique analgesia with sodium channel nerve blockade pharmacotherapy (ie nerve block)
DRUGPerphenazine
This randomized group will receive 8 mg of perphenazine orally preoperatively.
DRUGAprepitant
This randomized group will receive 40 mg of aprepitant orally preoperatively.
DRUGDimenhydrinate
This randomized group will receive 25 mg of dimenhydrinate orally preoperatively.
DRUGOndansetron 4 MG
This randomized group will receive 4 mg of ondansetron orally.
DRUGDexamethasone
This randomized group will receive 4-5 mg of dexamethasone intravenously.
DRUGRegional Block 2: QL1
This randomized group will receive regional technique analgesia with sodium channel nerve blockade pharmacotherapy (ie nerve block)
Sponsors
Berry Consultants
Jennifer Holder-Murray
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is seen in preoperative appointment prior to surgery 2. ≥ 18 years of age 3. Anticipated overnight hospital stay 4. Scheduled for elective abdominal surgery that utilizes ERP PowerPlans - placed into the patient's electronic chart at least one night before surgery 5. ERP Abdominal Complex Pathway PowerPlan (used for colorectal and gastrointestinal surgery) 6. ERP Bariatric Surgery Pathway PowerPlan 7. ERP Gynecology Oncology Pathway PowerPlan 8. ERP Whipple/Pancreas Pathway PowerPlan 9. ERP Open Liver Resection Pathway PowerPlan 10. Surgery is scheduled for one of the following UPMC sites: 11. UPMC Presbyterian Hospital 12. UPMC Passavant Hospital 13. UPMC Magee-Women's Hospital Exclusion Critera 1. Death is deemed to be imminent or inevitable 2. Patient is pregnant \< 18 years of age 3. Patients undergoing emergent/urgent surgery 4. Patients that are pregnant 5. Patients that have an eligible PowerPlan ordered less than one night before surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30 day hospital free days | Day 0 - Day 30 | The primary endpoint for this domain is the REMAP Periop primary outcome of hospital free days at 30 days after the elective surgical encounter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in postoperative nausea and vomiting (PONV) by measurement incidences of emesis within 24 hours post surgery | 0 - 24 hours surgery | Change in number of incidences of emesis 24 hours post surgery |
| Change in the rate of postoperative opioid use by measurement of oral morphine equivalents (OME) postoperative day 0 to postoperative day 1 | Day 0 - Day 1 | Change in the rate (mg/day) of Oral Morphine Equivalents administered |
Countries
United States
Outcome results
None listed