Enhanced Recovery Protocols for Perioperative Optimization

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to enhance patient recovery after surgery. It tests various treatment combinations before, during, and after surgery to improve recovery, reduce nausea, and control pain. The trial examines different approaches, such as specific painkillers or anti-nausea medications, to determine the most effective options for patients undergoing elective abdominal surgeries. These methods are part of the Recommendations of Enhanced Recovery Interventions, also known as Enhanced Recovery After Surgery (ERAS) or Enhanced Recovery Protocol (ERP). Individuals scheduled for abdominal surgery at specific UPMC hospitals, with an expected overnight stay, might be suitable for this trial. As a Phase 3 trial, this study serves as the final step before FDA approval, allowing participants to contribute to potentially groundbreaking advancements in surgical recovery.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using morphine directly in the spine (intrathecal morphine) for pain relief during surgery is generally safe and effective. It can reduce the risk of breathing problems by up to 25% and outperforms some other pain relief methods for abdominal surgeries.

Paravertebral blocks are a popular and safe choice for pain relief around surgery. Guidelines highlight their safety and effectiveness, and doctors widely trust them.

To prevent nausea and vomiting after surgery, drugs like ondansetron and dexamethasone are effective. These medications are well-researched and commonly used, making them reliable options.

Combining spinal morphine with paravertebral blocks can enhance recovery and reduce the need for other pain medications. Studies have found this combination to be safe and effective.

In summary, the treatments tested in this trial are supported by strong research, showing they are generally safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Enhanced Recovery Protocols for Perioperative Optimization because they aim to improve the overall experience and outcomes for patients undergoing major abdominal surgery. Unlike the standard approaches that often rely on general anesthesia with basic pain management, these protocols explore a combination of neuraxial and regional analgesia techniques. This includes innovative uses of intrathecal morphine and paravertebral blocks, which may provide more effective pain relief and faster recovery times. Additionally, the trial is testing advanced prophylaxis methods to prevent postoperative nausea and vomiting (PONV), which could significantly enhance patient comfort and satisfaction. The study's comprehensive approach could lead to a more efficient recovery process, less reliance on opioids, and improved patient outcomes.

What evidence suggests that this trial's treatments could be effective for enhancing recovery in perioperative care?

This trial will compare various enhanced recovery strategies for perioperative optimization. Research has shown that intrathecal morphine, which participants in one arm of this trial may receive, can help control pain and reduce the need for other pain medications after surgery. Studies have found it offers better pain relief than oral or injected painkillers. Another method under study in this trial is paravertebral blocks, which numb a specific area and have effectively reduced pain after surgery and shortened hospital stays. To manage nausea and vomiting after surgery, medications like ondansetron and dexamethasone, included in the PONV prophylaxis arms of this trial, have significantly lowered the risk. Using these strategies as part of enhanced recovery plans can lead to better outcomes, such as less pain and fewer nausea symptoms after surgery. ^{3 4 5 6 7}

Who Is on the Research Team?

Stephen Esper, MD, MBA

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

The participant is expected to pass away very soon, and there is nothing that can be done to prevent it.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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 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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2772609625000103

Analgesia using intrathecal morphine to improve quality of ... We hypothesise that intrathecal morphine will be superior to systemic opioids in terms of quality of postoperative recovery, pain control, opioid consumption, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6395101/

Pain Management in Enhanced Recovery after Surgery ... An RCT of intrathecal morphine versus epidural analgesia in laparoscopic colorectal surgery showed improved postoperative pain control, early return to ...

3. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/1912411

Analgesia After Open Abdominal Surgery in the Setting of ... Following qualitative assessment, epidural analgesia was associated with faster return of gut function and reduced pain scores; however, no difference was ...

4. dmr.amegroups.org dmr.amegroups.org/article/view/8168/html

Neuraxial anaesthesia and its role in enhanced recovery after ... They found a significant improvement in pain scores at rest on postoperative day 1 and on coughing on days 1 to 3 (10) when compared to a patient or physician- ...

5. perioperativemedicinejournal.biomedcentral.com perioperativemedicinejournal.biomedcentral.com/articles/10.1186/s13741-023-00324-0

Postoperative analgesia for upper gastrointestinal surgery We found that thoracic epidural analgesia was superior to intrathecal morphine, and intrathecal morphine was superior to non-neuraxial analgesia.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1365182X21001787

Evaluation of the addition of bupivacaine to intrathecal ... The aim of this retrospective study was to compare the analgesic efficacy and other secondary benefits of the addition of hyperbaric bupivacaine to intrathecal ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11978349/

Analgesia using intrathecal morphine to improve quality of ... This trial is expected to provide evidence on the effectiveness and the safety of two different ITM doses with local anaesthetic in major minimally invasive ...