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

NCT04606264 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: STUDY19030022
• Study Type: interventional
• Target: 2,977
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Perioperative Optimization

Keywords

perioperative; enhanced recovery; patient-directed care; randomized embedded multifactorial adaptive platform; REMAP; ERP; 90-day hospital free days; length of stay; perioperative optimization; oral morphine equivalents; postoperative nausea and vomiting; readmission

Outcome Measures

Primary Outcomes (1)

• 30 day hospital free days

  The primary endpoint for this domain is the REMAP Periop primary outcome of hospital free days at 30 days after the elective surgical encounter.

  Day 0 - Day 30

Secondary Outcomes (2)

• Change in postoperative nausea and vomiting (PONV) by measurement incidences of emesis within 24 hours post surgery

  0 - 24 hours surgery

• Change in the rate of postoperative opioid use by measurement of oral morphine equivalents (OME) postoperative day 0 to postoperative day 1

  Day 0 - Day 1

Study Arms (7)

Major Abdominal: Neuraxial Analgesia

ACTIVE COMPARATOR

Intrathecal morphine

Drug: Neuraxial Analgesia

Major Abdominal: Regional Analgesia Block 1

ACTIVE COMPARATOR

Paravertebral block

Drug: Regional Block 1: Paravertebral

Major Abdominal: PONV Optimal Prophylaxis

ACTIVE COMPARATOR

Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron

Drug: Perphenazine; Drug: Ondansetron 4 MG; Drug: Dexamethasone

Major Abdominal: PONV Supraoptimal Prophylaxis

ACTIVE COMPARATOR

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

Drug: Perphenazine; Drug: Aprepitant; Drug: Dimenhydrinate; Drug: Ondansetron 4 MG; Drug: Dexamethasone

Major Abdominal: Regional Analgesia Block 2

ACTIVE COMPARATOR

QL1

Drug: Regional Block 2: QL1

Major Abdominal: Neuraxial and Regional Analgesia Block 2

ACTIVE COMPARATOR

IT morphine and QL1

Drug: Neuraxial Analgesia; Drug: Regional Block 2: QL1

Major Abdominal: Neuraxial and Regional Analgesia Block 1

ACTIVE COMPARATOR

IT morphine and paravertebral

Drug: Neuraxial Analgesia; Drug: Regional Block 1: Paravertebral

Interventions

Neuraxial Analgesia DRUG

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

Also known as: Intrathecal morphine/hydromorphone, IT morphine/hydromorphine

Major Abdominal: Neuraxial Analgesia; Major Abdominal: Neuraxial and Regional Analgesia Block 1; Major Abdominal: Neuraxial and Regional Analgesia Block 2

Regional Block 1: Paravertebral DRUG

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

Also known as: Nerve Block

Major Abdominal: Neuraxial and Regional Analgesia Block 1; Major Abdominal: Regional Analgesia Block 1

Perphenazine DRUG

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

Major Abdominal: PONV Optimal Prophylaxis; Major Abdominal: PONV Supraoptimal Prophylaxis

Aprepitant DRUG

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

Major Abdominal: PONV Supraoptimal Prophylaxis

Dimenhydrinate DRUG

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

Major Abdominal: PONV Supraoptimal Prophylaxis

Ondansetron 4 MG DRUG

This randomized group will receive 4 mg of ondansetron orally.

Major Abdominal: PONV Optimal Prophylaxis; Major Abdominal: PONV Supraoptimal Prophylaxis

Dexamethasone DRUG

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

Major Abdominal: PONV Optimal Prophylaxis; Major Abdominal: PONV Supraoptimal Prophylaxis

Regional Block 2: QL1 DRUG

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

Also known as: Nerve Block

Major Abdominal: Neuraxial and Regional Analgesia Block 2; Major Abdominal: Regional Analgesia Block 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is seen in preoperative appointment prior to surgery
• ≥ 18 years of age
• Anticipated overnight hospital stay
• Scheduled for elective abdominal surgery that utilizes ERP PowerPlans - placed into the patient's electronic chart at least one night before surgery
• ERP Abdominal Complex Pathway PowerPlan (used for colorectal and gastrointestinal surgery)
• ERP Bariatric Surgery Pathway PowerPlan
• ERP Gynecology Oncology Pathway PowerPlan
• ERP Whipple/Pancreas Pathway PowerPlan
• ERP Open Liver Resection Pathway PowerPlan
• Surgery is scheduled for one of the following UPMC sites:
• UPMC Presbyterian Hospital
• UPMC Passavant Hospital
• UPMC Magee-Women's Hospital
• Death is deemed to be imminent or inevitable
• Patient is pregnant \< 18 years of age

Sponsors & Collaborators

• Jennifer Holder-Murray: lead
• Berry Consultants: collaborator

Study Sites (3)

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Passavant

Pittsburgh, Pennsylvania, 15237, United States

Location

Related Publications (1)

• Holder-Murray J, Esper SA, Althans AR, Knight J, Subramaniam K, Derenzo J, Ball R, Beaman S, Luke C, La Colla L, Schott N, Williams B, Lorenzi E, Berry LR, Viele K, Berry S, Masters M, Meister KA, Wilkinson T, Garrard W, Marroquin OC, Mahajan A. REMAP Periop: a randomised, embedded, multifactorial adaptive platform trial protocol for perioperative medicine to determine the optimal enhanced recovery pathway components in complex abdominal surgery patients within a US healthcare system. BMJ Open. 2023 Dec 28;13(12):e078711. doi: 10.1136/bmjopen-2023-078711.

  PMID: 38154902 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Hydromorphone; Nerve Block; Perphenazine; Aprepitant; Dimenhydrinate; Ondansetron; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Diphenhydramine; Ethylamines; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Drug Combinations; Pharmaceutical Preparations; Imidazoles; Azoles; Carbazoles; Indoles; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Officials

• Stephen Esper, MD, MBA

  University of Pittsburgh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 28, 2020
• Study Start: May 15, 2023
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Relevant data may be available 1 year following publication.
• Access Criteria: Data access is subject to a methodically sound proposal and the necessary data sharing agreements.

Locations

US (3)