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COMPLETED
NCT04606264
PHASE3

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

Sponsor: Jennifer Holder-Murray

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3395

Start Date

2023-05-15

Completion Date

2025-03-21

Last Updated

2026-05-28

Healthy Volunteers

No

Interventions

DRUG

Neuraxial Analgesia

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

DRUG

Regional Block 1: Paravertebral

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

DRUG

Perphenazine

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

DRUG

Aprepitant

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

DRUG

Dimenhydrinate

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

DRUG

Ondansetron 4 MG

This randomized group will receive 4 mg of ondansetron orally.

DRUG

Dexamethasone

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

DRUG

Regional Block 2: QL1

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

Locations (3)

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

UPMC Passavant

Pittsburgh, Pennsylvania, United States