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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2977 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2025-03-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Perioperative Optimization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Major Abdominal: Neuraxial Analgesia

Intrathecal morphine

Group Type ACTIVE_COMPARATOR

Neuraxial Analgesia

Intervention Type DRUG

This randomized group will receive a neuraxial morphine injection (intrathecal morphine/hydromorphone).

Major Abdominal: Regional Analgesia Block 1

Paravertebral block

Group Type ACTIVE_COMPARATOR

Regional Block 1: Paravertebral

Intervention Type DRUG

This randomized group will receive regional technique analgesia with sodium channel nerve blockade pharmacotherapy (ie nerve block)

Major Abdominal: PONV Optimal Prophylaxis

Pre-op

-perphenazine

Induction -dexamethasone

Emergence

-ondansetron

Group Type ACTIVE_COMPARATOR

Perphenazine

Intervention Type DRUG

This randomized group will receive 8 mg of perphenazine orally preoperatively.

Ondansetron 4 MG

Intervention Type DRUG

This randomized group will receive 4 mg of ondansetron orally.

Dexamethasone

Intervention Type DRUG

This randomized group will receive 4-5 mg of dexamethasone intravenously.

Major Abdominal: PONV Supraoptimal Prophylaxis

Pre-op

* aprepitant
* dimenhydrinate
* perphenazine
* ondansetron

Induction -dexamethasone

Emergence

-ondansetron

Group Type ACTIVE_COMPARATOR

Perphenazine

Intervention Type DRUG

This randomized group will receive 8 mg of perphenazine orally preoperatively.

Aprepitant

Intervention Type DRUG

This randomized group will receive 40 mg of aprepitant orally preoperatively.

Dimenhydrinate

Intervention Type DRUG

This randomized group will receive 25 mg of dimenhydrinate orally preoperatively.

Ondansetron 4 MG

Intervention Type DRUG

This randomized group will receive 4 mg of ondansetron orally.

Dexamethasone

Intervention Type DRUG

This randomized group will receive 4-5 mg of dexamethasone intravenously.

Major Abdominal: Regional Analgesia Block 2

QL1

Group Type ACTIVE_COMPARATOR

Regional Block 2: QL1

Intervention Type DRUG

This randomized group will receive regional technique analgesia with sodium channel nerve blockade pharmacotherapy (ie nerve block)

Major Abdominal: Neuraxial and Regional Analgesia Block 2

IT morphine and QL1

Group Type ACTIVE_COMPARATOR

Neuraxial Analgesia

Intervention Type DRUG

This randomized group will receive a neuraxial morphine injection (intrathecal morphine/hydromorphone).

Regional Block 2: QL1

Intervention Type DRUG

This randomized group will receive regional technique analgesia with sodium channel nerve blockade pharmacotherapy (ie nerve block)

Major Abdominal: Neuraxial and Regional Analgesia Block 1

IT morphine and paravertebral

Group Type ACTIVE_COMPARATOR

Neuraxial Analgesia

Intervention Type DRUG

This randomized group will receive a neuraxial morphine injection (intrathecal morphine/hydromorphone).

Regional Block 1: Paravertebral

Intervention Type DRUG

This randomized group will receive regional technique analgesia with sodium channel nerve blockade pharmacotherapy (ie nerve block)

Interventions

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Neuraxial Analgesia

This randomized group will receive a neuraxial morphine injection (intrathecal morphine/hydromorphone).

Intervention Type DRUG

Regional Block 1: Paravertebral

This randomized group will receive regional technique analgesia with sodium channel nerve blockade pharmacotherapy (ie nerve block)

Intervention Type DRUG

Perphenazine

This randomized group will receive 8 mg of perphenazine orally preoperatively.

Intervention Type DRUG

Aprepitant

This randomized group will receive 40 mg of aprepitant orally preoperatively.

Intervention Type DRUG

Dimenhydrinate

This randomized group will receive 25 mg of dimenhydrinate orally preoperatively.

Intervention Type DRUG

Ondansetron 4 MG

This randomized group will receive 4 mg of ondansetron orally.

Intervention Type DRUG

Dexamethasone

This randomized group will receive 4-5 mg of dexamethasone intravenously.

Intervention Type DRUG

Regional Block 2: QL1

This randomized group will receive regional technique analgesia with sodium channel nerve blockade pharmacotherapy (ie nerve block)

Intervention Type DRUG

Other Intervention Names

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Intrathecal morphine/hydromorphone IT morphine/hydromorphine Nerve Block Nerve Block

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No