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

Phase 3

Recruiting

• Conditions: Perioperative Optimization
• Interventions: Drug: Neuraxial Analgesia; Drug: Perphenazine; Drug: Ondansetron 4 MG; Drug: Aprepitant; Drug: Dimenhydrinate; Drug: Dexamethasone

• Registration Number: NCT04606264
• Lead Sponsor: Jennifer Holder-Murray

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.

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.

Study Timeline

• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-28
• Study Start: 2023-05-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-06-07
• Study Completion: 2025-06-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Major Abdominal: PONV Optimal Prophylaxis	Ondansetron 4 MG	Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron
Major Abdominal: Neuraxial Analgesia	Neuraxial Analgesia	Intrathecal morphine
Major Abdominal: PONV Supraoptimal Prophylaxis	Ondansetron 4 MG	Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron
Major Abdominal: Neuraxial and Regional Analgesia Block 2	Neuraxial Analgesia	IT morphine and QL1
Major Abdominal: Neuraxial and Regional Analgesia Block 1	Neuraxial Analgesia	IT morphine and paravertebral
Major Abdominal: PONV Optimal Prophylaxis	Perphenazine	Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron
Major Abdominal: PONV Supraoptimal Prophylaxis	Perphenazine	Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron
Major Abdominal: PONV Supraoptimal Prophylaxis	Aprepitant	Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron
Major Abdominal: PONV Supraoptimal Prophylaxis	Dimenhydrinate	Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron
Major Abdominal: PONV Optimal Prophylaxis	Dexamethasone	Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron
Major Abdominal: PONV Supraoptimal Prophylaxis	Dexamethasone	Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron

Primary Outcome Measures

Name	Time	Method
30 day hospital free days	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 Outcome Measures

Name	Time	Method
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	Change in the rate (mg/day) of Oral Morphine Equivalents administered
Change in postoperative nausea and vomiting (PONV) by measurement incidences of emesis within 24 hours post surgery	0 - 24 hours surgery	Change in number of incidences of emesis 24 hours post surgery

Trial Locations

Locations (3)

UPMC Magee-Womens Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Presbyterian; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Passavant; 🇺🇸 Pittsburgh, Pennsylvania, United States