Recommendations of Enhanced Recovery Interventions for Patient's Clinical Team and Collection of Associated Data

Jennifer Holder-Murray

Status and phase: Completed; Phase 3

Conditions: Perioperative Optimization

Treatments: Drug: Aprepitant; Drug: Perphenazine; Drug: Regional Block 1: Paravertebral; Drug: Dexamethasone; Drug: Regional Block 2: QL1; Drug: Ondansetron 4 MG; Drug: Dimenhydrinate; Drug: Neuraxial Analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04606264

STUDY19030022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,395 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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3,395 participants in 10 patient groups

PONV Optimal Prophylaxis & Neuraxial Analgesia

Active Comparator group

Description:

PONV Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Analgesia Intrathecal Morphine

Treatment:

Drug: Neuraxial Analgesia

Drug: Ondansetron 4 MG

Drug: Dexamethasone

Drug: Perphenazine

PONV Supraoptimal Prophylaxis & Neuraxial Analgesia

Active Comparator group

Description:

PONV Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Analgesia Intrathecal morphine

Treatment:

Drug: Neuraxial Analgesia

Drug: Ondansetron 4 MG

Drug: Dimenhydrinate

Drug: Dexamethasone

Drug: Perphenazine

Drug: Aprepitant

PONV Supraoptimal Prophylaxis & Regional Analgesia Block 1

Active Comparator group

Description:

PONV Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Analgesia Paravertebral block

Treatment:

Drug: Ondansetron 4 MG

Drug: Dimenhydrinate

Drug: Dexamethasone

Drug: Perphenazine

Drug: Regional Block 1: Paravertebral

Drug: Aprepitant

PONV Supraoptimal Prophylaxis & Regional Analgesia Block 2

Active Comparator group

Description:

PONV Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Analgesia QL1

Treatment:

Drug: Regional Block 2: QL1

Drug: Ondansetron 4 MG

Drug: Dimenhydrinate

Drug: Dexamethasone

Drug: Perphenazine

Drug: Aprepitant

PONV Supraoptimal Prophylaxis & Neuraxial and Regional Analgesia Block 1

Active Comparator group

Description:

PONV Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Analgesia IT morphine and Paravertebral

Treatment:

Drug: Neuraxial Analgesia

Drug: Ondansetron 4 MG

Drug: Dimenhydrinate

Drug: Dexamethasone

Drug: Perphenazine

Drug: Regional Block 1: Paravertebral

Drug: Aprepitant

PONV Supraoptimal Prophylaxis & Neuraxial and Regional Analgesia Block 2

Active Comparator group

Description:

PONV Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Analgesia IT morphine and QL1

Treatment:

Drug: Neuraxial Analgesia

Drug: Regional Block 2: QL1

Drug: Ondansetron 4 MG

Drug: Dimenhydrinate

Drug: Dexamethasone

Drug: Perphenazine

Drug: Aprepitant

PONV Optimal Prophylaxis & Regional Analgesia Block 1

Active Comparator group

Description:

PONV Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Analgesia Paravertebral Block

Treatment:

Drug: Ondansetron 4 MG

Drug: Dexamethasone

Drug: Perphenazine

Drug: Regional Block 1: Paravertebral

PONV Optimal Prophylaxis & Regional Analgesia Block 2

Active Comparator group

Description:

PONV Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Analgesia QL1

Treatment:

Drug: Regional Block 2: QL1

Drug: Ondansetron 4 MG

Drug: Dexamethasone

Drug: Perphenazine

PONV Optimal Prophylaxis and Neuraxial & Regional Analgesia Block 1

Active Comparator group

Description:

PONV Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Analgesia Intrathecal Morphine \& Paravertebral Block

Treatment:

Drug: Neuraxial Analgesia

Drug: Ondansetron 4 MG

Drug: Dexamethasone

Drug: Perphenazine

Drug: Regional Block 1: Paravertebral

PONV Optimal Prophylaxis and Neuraxial & Regional Analgesia Block 2

Active Comparator group

Description:

PONV Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Analgesia Intrathecal Morphine \& QL1

Treatment:

Drug: Neuraxial Analgesia

Drug: Regional Block 2: QL1

Drug: Ondansetron 4 MG

Drug: Dexamethasone

Drug: Perphenazine