Enhanced Recovery Protocols for Perioperative Optimization

Recruiting at 3 trial locations

Overseen By Miranda Masters

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Jennifer Holder-Murray

Disqualifiers: Pregnancy, Urgent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

2500 Participants Needed

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.

Do 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.

What 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. ^{1 2 3 4 5}

Is 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. ^{1 3 6 7 8}

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. ^{1 3 9 10 11}

Research Team

Stephen Esper, MD, MBA

Principal Investigator

University of Pittsburgh

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.

I have a preoperative appointment before my surgery.

Exclusion Criteria

I had emergency surgery without prior notice.

I have not been part of this study or had surgery at UPMC in the last month.

You are currently pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Care

Participants receive preoperative care including recommended standard of care treatments to optimize recovery

1 week

1 visit (in-person)

Intraoperative Care

Participants receive intraoperative care with various analgesia and prophylaxis strategies to enhance recovery

Day of surgery

1 visit (in-person)

Postoperative Care

Participants receive postoperative care to monitor and manage pain, nausea, and recovery

1-2 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on hospital free days and recovery outcomes

30 days

Treatment Details

Interventions

• Recommendations of Enhanced Recovery Interventions

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

Jennifer Holder-Murray

Lead Sponsor

Trials

1

Recruited

2,500+

Berry Consultants

Collaborator

Trials

16

Recruited

58,200+

Findings from Research

The implementation of the Enhanced Recovery After Surgery (ERAS) protocol for colorectal surgery significantly reduced the rate of moderate to severe complications from 31.9% in the Pre-ERAS group to 22.26% in the Post-ERAS group, indicating improved patient safety.

Patients in the Post-ERAS group also experienced a shorter median hospital stay, decreasing from 13 days in the Pre-ERAS group to 11 days, demonstrating the efficacy of the ERAS protocol in enhancing recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Enhanced recovery after surgery protocol versus conventional perioperative care in colorectal surgery. A single center cohort study]. Ripollés-Melchor, J., Fuenmayor-Varela, ML., Camargo, SC., et al.[2022]

The implementation of Enhanced Recovery After Surgery (ERAS) protocols in pelvic floor reconstructive surgery significantly reduced the length of hospital stay by an average of 16.17 hours and increased the likelihood of patients being discharged within 24 hours post-surgery.

Despite the benefits in recovery time, ERAS protocols did not show differences in operative time, blood loss, complications, or readmission rates compared to standard care, indicating that while ERAS improves recovery, it maintains safety and efficacy similar to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced Recovery Protocols in Urogynecologic and Pelvic Floor Reconstructive Surgery: A Systematic Review and Meta-Analysis. Zacharakis, D., Diakosavvas, M., Prodromidou, A., et al.[2023]

The implementation of an electronic notification system significantly improved adherence to Enhanced Recovery After Surgery (ERAS) protocols among anesthesia providers, increasing overall adherence from 16% to 44%.

While the study showed improved adherence to specific preoperative measures like oral gabapentin and celebrex, it did not find significant differences in secondary outcomes such as postoperative pain scores or length of stay, indicating that while protocol adherence improved, it did not necessarily translate to better patient outcomes.

NCBI (Pubmed)

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. Gopwani, S., Bahrun, E., Singh, T., et al.[2023]

In a survey of 235 general surgeons across 84 Ontario hospitals, only 20% consistently implemented all 9 Enhanced Recovery After Surgery (ERAS) behaviors, indicating significant variation in colorectal surgery practices.

Surgeons in academic settings tended to adopt more ERAS behaviors compared to those in smaller community hospitals, but factors like colorectal fellowship training did not significantly influence ERAS utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The predictors of Enhanced Recovery After Surgery utilization and practice variations in elective colorectal surgery: a provincial survey. Springer, JE., Doumouras, AG., Lethbridge, S., et al.[2020]

A survey involving 109 patients and 57 care providers across three countries showed strong support for Enhanced Recovery After Surgery (ERAS) principles, indicating a shared belief in their importance for improving surgical outcomes.

Both patients and care providers prioritized freedom from nausea and pain at rest as the most critical components of ERAS, while there was less agreement on the importance of early bowel function and avoiding preanesthetic sedation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attitudes of patients and care providers to enhanced recovery after surgery programs after major abdominal surgery. Hughes, M., Coolsen, MM., Aahlin, EK., et al.[2022]

The implementation of a pediatric Enhanced Recovery After Surgery (ERAS) protocol for reverse stoma surgery significantly reduced the length of hospital stay from an average of 8.64 days to 6.08 days, indicating improved recovery times.

Patients in the ERAS group experienced faster recovery milestones, such as a decrease in time to oral fluid intake from 4.36 days to 1 day and time to regular diet from 6.14 days to 3.23 days, demonstrating the protocol's efficacy in enhancing postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing enhanced recovery after surgery protocol in pediatric surgery. Modrzyk, A., Pasierbek, MJ., Korlacki, W., et al.[2020]

A tailored implementation strategy based on the Knowledge-to-Action (KTA) cycle successfully developed and implemented Enhanced Recovery After Surgery (ERAS) clinical practice guidelines across 15 academic hospitals in Canada.

Preliminary data from over 1000 patients indicate that while compliance with recommended interventions varied, the implementation of ERAS protocols led to a decrease in mean length of hospital stay and maintained low rates of readmissions and adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an Enhanced Recovery After Surgery Guideline and Implementation Strategy Based on the Knowledge-to-action Cycle. McLeod, RS., Aarts, MA., Chung, F., et al.[2022]

Enhanced recovery after surgery (ERAS) protocols are designed to reduce the stress of surgery and improve patient outcomes, potentially leading to lower healthcare costs.

These protocols consist of multimodal care 'bundles' that, when fully implemented, can provide significant cumulative benefits, although some components may lack strong scientific evidence despite being widely accepted in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissecting the Perioperative Care Bundle. Cologne, KG., Hsieh, C.[2021]

The implementation of enhanced recovery protocols (ERPs) in pelvic reconstructive surgery led to a significant reduction in hospital stay length (from 29.9 to 27.9 hours) and decreased opioid use (from 37.4 to 19.4 mg total morphine equivalents), indicating improved recovery outcomes.

Patients in the ERP group experienced higher rates of early ambulation and increased patient satisfaction, while there were no increases in complications or hospital costs, demonstrating the safety and efficacy of ERPs in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced recovery program for minimally invasive and vaginal urogynecologic surgery. Trowbridge, ER., Evans, SL., Sarosiek, BM., et al.[2022]

Enhanced recovery protocols (ERPs) are designed to standardize and improve perioperative care, especially during high-risk periods like the COVID-19 pandemic, to reduce complications and speed up recovery.

Modifications to ERPs during the pandemic include new practices such as patient education, preoperative COVID-19 testing, and strategies to reduce infection and thromboembolism risks, which are essential for optimizing surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advantages of, and Adaptations to, Enhanced Recovery Protocols for Perioperative Care during the COVID-19 Pandemic. Stone, R., Scheib, S.[2021]

ERAS protocols are effective in managing postoperative pain, potentially more so than traditional opioid regimens, by using a combination of medications that work together to block pain through multiple pathways.

In addition to medication, proper patient counseling about pain expectations and a holistic approach to perioperative care are crucial for enhancing recovery and minimizing reliance on opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Nuts and Bolts of a Successful Non-Narcotic Perioperative Enhanced Recovery After Surgery Protocol. Schultz, KP., Kaplan, J., Rappaport, NH.[2022]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

[Enhanced recovery after surgery protocol versus conventional perioperative care in colorectal surgery. A single center cohort study]. [2022]

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

Enhanced Recovery Protocols in Urogynecologic and Pelvic Floor Reconstructive Surgery: A Systematic Review and Meta-Analysis. [2023]

3. 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]

4. 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]

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

Attitudes of patients and care providers to enhanced recovery after surgery programs after major abdominal surgery. [2022]

6. Poland pubmed.ncbi.nlm.nih.gov

Introducing enhanced recovery after surgery protocol in pediatric surgery. [2020]

7. 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]

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

Dissecting the Perioperative Care Bundle. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Enhanced recovery program for minimally invasive and vaginal urogynecologic surgery. [2022]

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

Advantages of, and Adaptations to, Enhanced Recovery Protocols for Perioperative Care during the COVID-19 Pandemic. [2021]

11. England pubmed.ncbi.nlm.nih.gov

The Nuts and Bolts of a Successful Non-Narcotic Perioperative Enhanced Recovery After Surgery Protocol. [2022]