Enhanced Recovery Protocols for Perioperative Optimization
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Jennifer Holder-Murray
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
How is the Enhanced Recovery Protocol treatment different from other treatments?
Enhanced Recovery Protocols (ERPs) are unique because they are comprehensive, evidence-based guidelines that focus on optimizing all aspects of surgical care, including preoperative counseling, multimodal medication management, and early mobilization, to improve recovery and reduce complications, unlike traditional approaches that may not be as standardized or holistic.
347811Is the Enhanced Recovery After Surgery (ERAS) protocol safe for humans?
Enhanced Recovery After Surgery (ERAS) protocols are generally considered safe for humans, as they are designed to improve recovery and reduce complications after surgery. They have been successfully implemented in various types of surgeries, including colorectal and pediatric surgeries, with a focus on improving patient outcomes and reducing hospital stays.
235911What data supports the effectiveness of the Enhanced Recovery Protocols for Perioperative Optimization treatment?
Research shows that Enhanced Recovery After Surgery (ERAS) protocols help patients recover faster and reduce hospital stays and complications after surgeries like colorectal and pelvic floor surgeries. These protocols are based on evidence and are designed to improve the overall recovery experience for surgical patients.
1361011Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Eligibility Criteria
This trial is for patients at UPMC scheduled for elective surgery where Enhanced Recovery Protocols (ERP) are used. They must have a preoperative appointment before surgery. It's not for emergency surgeries, those who've been in this REMAP study or had surgery at UPMC within the last month, or pregnant individuals.Inclusion Criteria
My upcoming surgery will follow an Enhanced Recovery Pathway.
Exclusion Criteria
I had emergency surgery without prior notice.
Participant Groups
The study tests different combinations of standard care treatments to enhance recovery around the time of surgery. This includes various medications and regional anesthesia techniques aimed at reducing hospital stays, nausea/vomiting after surgery, and improving pain management.
7Treatment groups
Active Control
Group I: Major Abdominal: Neuraxial AnalgesiaActive Control1 Intervention
Intrathecal morphine
Group II: Major Abdominal: Regional Analgesia Block 1Active Control1 Intervention
Paravertebral block
Group III: Major Abdominal: PONV Optimal ProphylaxisActive Control3 Interventions
Pre-op
-perphenazine
Induction -dexamethasone
Emergence
-ondansetron
Group IV: Major Abdominal: PONV Supraoptimal ProphylaxisActive Control5 Interventions
Pre-op
* aprepitant
* dimenhydrinate
* perphenazine
* ondansetron
Induction -dexamethasone
Emergence
-ondansetron
Group V: Major Abdominal: Regional Analgesia Block 2Active Control1 Intervention
QL1
Group VI: Major Abdominal: Neuraxial and Regional Analgesia Block 2Active Control2 Interventions
IT morphine and QL1
Group VII: Major Abdominal: Neuraxial and Regional Analgesia Block 1Active Control2 Interventions
IT morphine and paravertebral
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
UPMC ShadysidePittsburgh, PA
UPMC PresbyterianPittsburgh, PA
UPMC PassavantPittsburgh, PA
UPMC Magee-Womens HospitalPittsburgh, PA
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Who is running the clinical trial?
Jennifer Holder-MurrayLead Sponsor
Berry ConsultantsCollaborator
References
Attitudes of patients and care providers to enhanced recovery after surgery programs after major abdominal surgery. [2022]Enhanced recovery after surgery (ERAS) is a well-established pathway of perioperative care in surgery in an increasing number of specialties. To implement protocols and maintain high levels of compliance, continued support from care providers and patients is vital. This survey aimed to assess the perceptions of care providers and patients of the relevance and importance of the ERAS targets and strategies.
Development of an Enhanced Recovery After Surgery Guideline and Implementation Strategy Based on the Knowledge-to-action Cycle. [2022]Enhanced Recovery After Surgery (ERAS) protocols have been shown to increase recovery, decrease complications, and reduce length of stay. However, they are difficult to implement.
[Enhanced recovery after surgery protocol versus conventional perioperative care in colorectal surgery. A single center cohort study]. [2022]Enhanced recovery after surgery (ERAS) protocols consist of a set of perioperative measures aimed at improving patient recovery and decreasing length of stay and postoperative complications. We assess the implementation and outcomes of an ERAS program for colorectal surgery.
Enhanced recovery program for minimally invasive and vaginal urogynecologic surgery. [2022]Enhanced recovery protocols (ERPs) are evidenced-based interventions designed to standardize perioperative care and expedite recovery to baseline functional status after surgery. There remains a paucity of data addressing the effect of ERPs on pelvic reconstructive surgery patients.
Introducing enhanced recovery after surgery protocol in pediatric surgery. [2020]Enhanced recovery after surgery (ERAS) is a holistic perioperative care protocol created to improve treatment outcomes. Implementation of new rules radically changed the perioperative care of adult patients. The protocol refers to the preoperative, intraoperative and postoperative periods.
The predictors of Enhanced Recovery After Surgery utilization and practice variations in elective colorectal surgery: a provincial survey. [2020]Enhanced Recovery After Surgery (ERAS) protocols use evidence-based perioperative practices that reduce morbidity and length of stay and improve patient satisfaction. ERAS is considered standard of care; however, utilization remains low and substantial practice variation exists. The aim of this study was to pragmatically characterize variation in colorectal surgery practice and identify predictors of ERAS utilization.
Advantages of, and Adaptations to, Enhanced Recovery Protocols for Perioperative Care during the COVID-19 Pandemic. [2021]This review formulates the rationale for using enhanced recovery protocols (ERPs) to standardize and optimize perioperative care during this high-risk time to minimize poor outcomes owing to provider, patient, and system vulnerabilities.
The Nuts and Bolts of a Successful Non-Narcotic Perioperative Enhanced Recovery After Surgery Protocol. [2022]Enhanced recovery after surgery (ERAS) protocols are widely utilized approaches to perioperative care that advocate preoperative counseling, multimodal perioperative medication management, and early postoperative mobilization to improve post-surgical patient outcomes and satisfaction.
Dissecting the Perioperative Care Bundle. [2021]Enhanced recovery after surgery (ERAS) protocols are comprehensive perioperative care pathways designed to mitigate the physiologic stressors associated with surgery and, in turn, improve clinical outcomes and lead to health care cost savings. Although individual components may differ, ERAS protocols are typically organized as multimodal care "bundles" that, when followed closely and in their entirety, are meant to generate amplified cumulative benefits. This manuscript examines some of the critical components, describes some areas where the science is weak (but dogma may be strong), and provides some of the evidence or lack thereof behind components of a standard ERAS protocol.
Enhanced Recovery Protocols in Urogynecologic and Pelvic Floor Reconstructive Surgery: A Systematic Review and Meta-Analysis. [2023]The implementation of Enhanced Recovery After Surgery (ERAS) protocols may optimize the clinical outcome of surgical patients, by reducing the length of hospital stay (LOS) and improving the quality of recovery.
Efficacy of Electronic Reminders in Increasing the Enhanced Recovery After Surgery Protocol Use During Major Breast Surgery: Prospective Cohort Study. [2023]Enhanced recovery after surgery (ERAS) protocols are patient-centered, evidence-based guidelines for peri-, intra-, and postoperative management of surgical candidates that aim to decrease operative complications and facilitate recovery after surgery. Anesthesia providers can use these protocols to guide decision-making and standardize aspects of their anesthetic plan in the operating room.