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Completed

NCT Number: NCT04606264

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UPMC Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion Critera

  • 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

Treatment and study plan

Neuraxial Analgesia

Drug

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

Other names: Intrathecal morphine/hydromorphone, IT morphine/hydromorphine

Regional Block 1: Paravertebral

Drug

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

Other names: Nerve Block

Perphenazine

Drug

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

Aprepitant

Drug

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

Dimenhydrinate

Drug

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

Ondansetron 4 MG

Drug

This randomized group will receive 4 mg of ondansetron orally.

Dexamethasone

Drug

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

Regional Block 2: QL1

Drug

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

Other names: Nerve Block

Primary outcomes

  1. 30 Day Hospital Free Days

    Time frame: Day 0 - Day 30

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

Secondary outcomes

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

    Time frame: 0 - 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)

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

    Time frame: 0-24 hours post-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

Sponsors and collaborators

Lead sponsor

Jennifer Holder-Murray

Other

Collaborators

  • Berry Consultants

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2020
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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