Recommendations of Enhanced Recovery Interventions for Patient's Clinical Team and Collection of Associated Data
Randomized, Embedded, Multifactorial Adaptive Platform for Perioperative Medicine at UPMC (UPMC REMAP): Core Protocol - Enhanced Recovery Protocols (ERP)
1 other identifier
interventional
3,395
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2023
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2020
CompletedFirst Posted
Study publicly available on registry
October 28, 2020
CompletedStudy Start
First participant enrolled
May 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2025
CompletedResults Posted
Study results publicly available
May 28, 2026
CompletedMay 28, 2026
May 1, 2026
1.9 years
October 8, 2020
March 20, 2026
May 1, 2026
Conditions
Keywords
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 post-surgery
Change in the Rate of Postoperative Opioid Use by Measurement of Oral Morphine Equivalents (OME) Measured 24 Hours After Surgery
0-24 hours post-surgery
Study Arms (10)
PONV Optimal Prophylaxis & Neuraxial Analgesia
ACTIVE COMPARATORPONV Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Analgesia Intrathecal Morphine
PONV Supraoptimal Prophylaxis & Neuraxial Analgesia
ACTIVE COMPARATORPONV Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Analgesia Intrathecal morphine
PONV Supraoptimal Prophylaxis & Regional Analgesia Block 1
ACTIVE COMPARATORPONV Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Analgesia Paravertebral block
PONV Supraoptimal Prophylaxis & Regional Analgesia Block 2
ACTIVE COMPARATORPONV Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Analgesia QL1
PONV Supraoptimal Prophylaxis & Neuraxial and Regional Analgesia Block 1
ACTIVE COMPARATORPONV Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Analgesia IT morphine and Paravertebral
PONV Supraoptimal Prophylaxis & Neuraxial and Regional Analgesia Block 2
ACTIVE COMPARATORPONV Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Analgesia IT morphine and QL1
PONV Optimal Prophylaxis & Regional Analgesia Block 1
ACTIVE COMPARATORPONV Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Analgesia Paravertebral Block
PONV Optimal Prophylaxis & Regional Analgesia Block 2
ACTIVE COMPARATORPONV Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Analgesia QL1
PONV Optimal Prophylaxis and Neuraxial & Regional Analgesia Block 1
ACTIVE COMPARATORPONV Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Analgesia Intrathecal Morphine \& Paravertebral Block
PONV Optimal Prophylaxis and Neuraxial & Regional Analgesia Block 2
ACTIVE COMPARATORPONV Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Analgesia Intrathecal Morphine \& QL1
Interventions
This randomized group will receive a neuraxial morphine injection (intrathecal morphine/hydromorphone).
This randomized group will receive regional technique analgesia with sodium channel nerve blockade pharmacotherapy (ie nerve block)
This randomized group will receive 8 mg of perphenazine orally preoperatively.
This randomized group will receive 40 mg of aprepitant orally preoperatively.
This randomized group will receive 25 mg of dimenhydrinate orally preoperatively.
This randomized group will receive 4 mg of ondansetron orally.
This randomized group will receive 4-5 mg of dexamethasone intravenously.
This randomized group will receive regional technique analgesia with sodium channel nerve blockade pharmacotherapy (ie nerve block)
Eligibility Criteria
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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jennifer Holder-Murraylead
- Berry Consultantscollaborator
Study Sites (3)
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
UPMC Passavant
Pittsburgh, Pennsylvania, 15237, United States
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: 38154902DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer Holder-Murray, MD, FACS, FASCRS
- Organization
- UPMC
Study Officials
- STUDY CHAIR
Stephen Esper, MD, MBA
University of Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- Yes
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
May 28, 2026
Results First Posted
May 28, 2026
Record last verified: 2026-05
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.
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.