Perioperative Optimization > Recommendations Of Enhanced Recovery Interventions

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.

What data supports the idea that Enhanced Recovery Protocols for Perioperative Optimization is an effective treatment?

The available research shows that Enhanced Recovery Protocols (ERAS) are effective in improving patient recovery after surgery. For example, in colorectal surgery, ERAS protocols help reduce the length of hospital stay and decrease postoperative complications. Similarly, in urogynecologic and pelvic floor surgeries, ERAS protocols have been shown to optimize clinical outcomes by shortening hospital stays and enhancing recovery quality. These protocols are considered standard care in many surgical fields, although their use varies. Overall, ERAS protocols are effective in making recovery faster and safer compared to traditional care methods.^{1 3 6 10 11}

Is the treatment called Enhanced Recovery Interventions a promising treatment?

Yes, Enhanced Recovery Interventions are promising because they help patients recover faster after surgery, reduce complications, and improve overall satisfaction by using a set of guidelines for care before, during, and after surgery.^{3 4 7 8 11}

What safety data exists for Enhanced Recovery Protocols?

Enhanced Recovery After Surgery (ERAS) protocols have been shown to improve recovery, decrease complications, and reduce length of stay in various surgical contexts, including colorectal and pediatric surgeries. They are evidence-based guidelines that standardize perioperative care to mitigate surgical stress and improve outcomes. However, while ERAS protocols are generally considered safe and beneficial, their implementation can be challenging, and the evidence supporting some components may vary.^{2 3 5 9 11}

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to consult with the trial coordinators or your doctor for guidance.

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.

Group I: Major Abdominal: Neuraxial Analgesia Active Control 1 Intervention

Intrathecal morphine

Group II: Major Abdominal: Regional Analgesia Block 1 Active Control 1 Intervention

Paravertebral block

Group III: Major Abdominal: PONV Optimal Prophylaxis Active Control 3 Interventions

Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron

Group IV: Major Abdominal: PONV Supraoptimal Prophylaxis Active Control 5 Interventions

Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron

Group V: Major Abdominal: Regional Analgesia Block 2 Active Control 1 Intervention

QL1

Group VI: Major Abdominal: Neuraxial and Regional Analgesia Block 2 Active Control 2 Interventions

IT morphine and QL1

Group VII: Major Abdominal: Neuraxial and Regional Analgesia Block 1 Active Control 2 Interventions

IT morphine and paravertebral

Find A Clinic Near You

Research locations nearby Select from list below to view details:

UPMC Shadyside Pittsburgh, PA

UPMC Presbyterian Pittsburgh, PA

UPMC Passavant Pittsburgh, PA

UPMC Magee-Womens Hospital Pittsburgh, PA

Who is running the clinical trial?

Jennifer Holder-Murray Lead Sponsor

Berry Consultants Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

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.

2. United States pubmed.ncbi.nlm.nih.gov

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.

3. Brazil pubmed.ncbi.nlm.nih.gov

[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.

4. England pubmed.ncbi.nlm.nih.gov

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.

5. Poland pubmed.ncbi.nlm.nih.gov

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.

6. Canada pubmed.ncbi.nlm.nih.gov

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.

7. United States pubmed.ncbi.nlm.nih.gov

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.

8. England pubmed.ncbi.nlm.nih.gov

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.

9. United States pubmed.ncbi.nlm.nih.gov

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.

10. United States pubmed.ncbi.nlm.nih.gov

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.

11. Canada pubmed.ncbi.nlm.nih.gov

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.