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

Ketamine

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.

Intervention / Treatment

  • Neuraxial Analgesia (DRUG)
    This randomized group will receive a neuraxial morphine injection (intrathecal morphine/hydromorphone).
  • Regional Block 1: Paravertebral (DRUG)
    This randomized group will receive regional technique analgesia with sodium channel nerve blockade pharmacotherapy (ie 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)

Condition or Disease

  • Perioperative Optimization

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Recruiting
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 35485 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

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    Clinical Trial Dates

    Start date: Apr 12, 2023 ACTUAL
    Primary Completion: Dec 30, 2024 ESTIMATED
    Completion Date: Dec 30, 2025 ESTIMATED
    Study First Posted: Oct 28, 2020 ACTUAL
    Last Updated: Jul 27, 2023

    Sponsors / Collaborators

    Lead Sponsor: Jennifer Holder-Murray
    Responsible Party: Jennifer Holder-Murray

    Location

    Pittsburgh, Pennsylvania, USA

    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.

    Participant Groups

    • Intrathecal morphine

    • Paravertebral block

    • Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron

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

    • QL1

    • IT morphine and QL1

    • IT morphine and paravertebral

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria

    1. Patient is seen in preoperative appointment prior to surgery
    2. Patient has been scheduled for a surgical type in which ERP has been implemented.

    Exclusion Critera

    1. Death is deemed to be imminent or inevitable
    2. Emergency surgical procedure without suitable lead-in time
    3. Previous participation in this REMAP within the last 30 days, flagged by elective or emergency surgical encounter at UPMC in the past 30 days
    4. Patient is pregnant

    This clinical trial is recruiting

    Are you interested in participating in this trial or others? We'd love to help.

    Primary Outcomes

    • 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

    • Change in number of doses of antiemetics administered 24 hours post surgery.

    • Change in number of incidences of emesis 24h post surgery

    • Change in the rate (mg/day) of Oral Morphine Equivalents administered

    • Change in opioid prescription/administration following discharge

    • Readmission or complications due to surgery on or before 30 days of surgical procedure

    • Incidences of adverse events as define in core protocol

    More Details

    NCT Number: NCT04606264
    Other IDs: STUDY19030022
    Study URL: https://clinicaltrials.gov/study/NCT04606264
    Last updated: Sep 29, 2023