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Perioperative OptimizationPhase 3NCT04606264

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

A Phase 3 study testing Neuraxial Analgesia, Regional Block 1: Paravertebral and Perphenazine in people with Perioperative Optimization, run by Jennifer Holder-Murray at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Perioperative Optimization
What is being tested?
Neuraxial Analgesia, Regional Block 1: Paravertebral and Perphenazine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,395 participants
Where
3 sitesUnited States
Study dates
15 May 2023to 21 Mar 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • Death is deemed to be imminent or inevitable
  • Patient is pregnant < 18 years of age
  • Patients undergoing emergent/urgent surgery
  • Patients that are pregnant
  • Patients that have an eligible PowerPlan ordered less than one night before surgery

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • UPMC Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213

  • UPMC Passavant

    Pittsburgh, Pennsylvania, 15237

Other trials in United States

About this study

Official title: Randomized, Embedded, Multifactorial Adaptive Platform for Perioperative Medicine at UPMC (UPMC REMAP): Core Protocol - Enhanced Recovery Protocols (ERP)

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.

Read the detailed 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.

Being tested
Neuraxial Analgesia, Regional Block 1: Paravertebral, Perphenazine, Aprepitant, Dimenhydrinate
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
Medical subject headings
Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuraxial AnalgesiaDrug

    Also called Intrathecal morphine/hydromorphone, IT morphine/hydromorphine

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

  • Regional Block 1: ParavertebralDrug

    Also called Nerve Block

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

  • PerphenazineDrug

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

  • AprepitantDrug

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

  • DimenhydrinateDrug

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

  • Ondansetron 4 MGDrug

    This randomized group will receive 4 mg of ondansetron orally.

  • DexamethasoneDrug

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

  • Regional Block 2: QL1Drug

    Also called Nerve Block

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

Study groups in NCT04606264
Study groupRoleWhat they receive
PONV Optimal Prophylaxis & Neuraxial AnalgesiaActive comparatorPONV Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Analgesia Intrathecal Morphine
Receives: Drug: Neuraxial Analgesia; Drug: Perphenazine; Drug: Ondansetron 4 MG; Drug: Dexamethasone
PONV Supraoptimal Prophylaxis & Neuraxial AnalgesiaActive comparatorPONV Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Analgesia Intrathecal morphine
Receives: Drug: Neuraxial Analgesia; Drug: Perphenazine; Drug: Aprepitant; Drug: Dimenhydrinate; Drug: Ondansetron 4 MG; Drug: Dexamethasone
PONV Supraoptimal Prophylaxis & Regional Analgesia Block 1Active comparatorPONV Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Analgesia Paravertebral block
Receives: Drug: Regional Block 1: Paravertebral; Drug: Perphenazine; Drug: Aprepitant; Drug: Dimenhydrinate; Drug: Ondansetron 4 MG; Drug: Dexamethasone
PONV Supraoptimal Prophylaxis & Regional Analgesia Block 2Active comparatorPONV Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Analgesia QL1
Receives: Drug: Perphenazine; Drug: Aprepitant; Drug: Dimenhydrinate; Drug: Ondansetron 4 MG; Drug: Dexamethasone; Drug: Regional Block 2: QL1
PONV Supraoptimal Prophylaxis & Neuraxial and Regional Analgesia Block 1Active comparatorPONV Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Analgesia IT morphine and Paravertebral
Receives: Drug: Neuraxial Analgesia; Drug: Regional Block 1: Paravertebral; Drug: Perphenazine; Drug: Aprepitant; Drug: Dimenhydrinate; Drug: Ondansetron 4 MG; Drug: Dexamethasone
PONV Supraoptimal Prophylaxis & Neuraxial and Regional Analgesia Block 2Active comparatorPONV Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Analgesia IT morphine and QL1
Receives: Drug: Neuraxial Analgesia; Drug: Perphenazine; Drug: Aprepitant; Drug: Dimenhydrinate; Drug: Ondansetron 4 MG; Drug: Dexamethasone; Drug: Regional Block 2: QL1
PONV Optimal Prophylaxis & Regional Analgesia Block 1Active comparatorPONV Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Analgesia Paravertebral Block
Receives: Drug: Regional Block 1: Paravertebral; Drug: Perphenazine; Drug: Ondansetron 4 MG; Drug: Dexamethasone
PONV Optimal Prophylaxis & Regional Analgesia Block 2Active comparatorPONV Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Analgesia QL1
Receives: Drug: Perphenazine; Drug: Ondansetron 4 MG; Drug: Dexamethasone; Drug: Regional Block 2: QL1
PONV Optimal Prophylaxis and Neuraxial & Regional Analgesia Block 1Active comparatorPONV Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Analgesia Intrathecal Morphine \& Paravertebral Block
Receives: Drug: Neuraxial Analgesia; Drug: Regional Block 1: Paravertebral; Drug: Perphenazine; Drug: Ondansetron 4 MG; Drug: Dexamethasone
PONV Optimal Prophylaxis and Neuraxial & Regional Analgesia Block 2Active comparatorPONV Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Analgesia Intrathecal Morphine \& QL1
Receives: Drug: Neuraxial Analgesia; Drug: Perphenazine; Drug: Ondansetron 4 MG; Drug: Dexamethasone; Drug: Regional Block 2: QL1

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 0 - Day 30

Secondary outcomes (2)

  1. Change in Postoperative Nausea and Vomiting (PONV) by Measurement Incidences of Emesis Within 24 Hours Post Surgery

    Did the participant receive postoperative antiemetic medication within 24 hours of completion of surgery (number of participants who did receive postoperative antiemetics)

    Measured: 0 - 24 hours post-surgery

  2. Change in the Rate of Postoperative Opioid Use by Measurement of Oral Morphine Equivalents (OME) Measured 24 Hours After Surgery

    OME measurement is a method to compare and standardize different opioids administered to participants to account for varying strengths. OME is measured as a rate in milligrams per day and modeled as a continuous endpoint. For analysis purposes, OME was converted to log(OME) + 1

    Measured: 0-24 hours post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2020
  2. Study start15 May 2023
  3. Primary completion21 Mar 2025
  4. Study completion21 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
This study has 2 domains, and each domain has its own arms. Domain 1: postoperative nausea and vomiting (Optimal Prophylaxis and Supraoptimal prophylaxis). Domain 2: Analgesia (Neuraxial block, regional block 1, regional block 2, neuraxial \& regional block 1, and neuraxial \& regional block 2). Each patient is randomized to one intervention in each domain. The randomization for one domain does not influence the randomization in the other domain. The trial is adaptive, so if one arm is more successful than another arm, the randomization weights will shift to favor the more successful arm. Unsuccessful arms can be dropped from the trial.
Masking
None (open label)
Enrolment
3,395 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04606264
Sponsor's protocol ID
STUDY19030022
Status last verified
May 2026
First submitted
8 Oct 2020
Last updated
28 May 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified participant-level data underlying the results reported in journal articles, subject to appropriate security controls, may be available for sharing with other researchers.

Publications

  • 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.

    PubMed 38154902

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Neuraxial Analgesia, Regional Block 1: Paravertebral and Perphenazine in people with Perioperative Optimization, run by Jennifer Holder-Murray at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30 Day Hospital Free Days (time frame: Day 0 - Day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04606264, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

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