Clinical trial

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

Name

STUDY19030022

Description

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 arms

Trial start

2023-05-15

Estimated PCD

2024-12-30

Trial end

2025-12-30

Status

Recruiting

Phase

Early phase I

Treatment

Neuraxial Analgesia

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

Arms:

Major Abdominal: Neuraxial Analgesia, Major Abdominal: Neuraxial and Regional Analgesia Block 1, Major Abdominal: Neuraxial and Regional Analgesia Block 2

Other names:

Intrathecal morphine/hydromorphone, IT morphine/hydromorphine

Regional Block 1: Paravertebral

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

Arms:

Major Abdominal: Neuraxial and Regional Analgesia Block 1, Major Abdominal: Regional Analgesia Block 1

Other names:

Nerve Block

Perphenazine

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

Arms:

Major Abdominal: PONV Optimal Prophylaxis, Major Abdominal: PONV Supraoptimal Prophylaxis

Aprepitant

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

Arms:

Major Abdominal: PONV Supraoptimal Prophylaxis

Dimenhydrinate

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

Arms:

Major Abdominal: PONV Supraoptimal Prophylaxis

Ondansetron 4 MG

This randomized group will receive 4 mg of ondansetron orally.

Arms:

Major Abdominal: PONV Optimal Prophylaxis, Major Abdominal: PONV Supraoptimal Prophylaxis

Dexamethasone

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

Arms:

Major Abdominal: PONV Optimal Prophylaxis, Major Abdominal: PONV Supraoptimal Prophylaxis

Regional Block 2: QL1

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

Arms:

Major Abdominal: Neuraxial and Regional Analgesia Block 2, Major Abdominal: Regional Analgesia Block 2

Other names:

Nerve Block

Size

2500

Primary endpoint

30 day hospital free days

Day 0 - Day 30

Eligibility criteria

Inclusion Criteria 1. Patient is seen in preoperative appointment prior to surgery 2. ≥ 18 years of age 3. Anticipated overnight hospital stay 4. Scheduled for elective abdominal surgery that utilizes ERP PowerPlans - placed into the patient's electronic chart at least one night before surgery 5. ERP Abdominal Complex Pathway PowerPlan (used for colorectal and gastrointestinal surgery) 6. ERP Bariatric Surgery Pathway PowerPlan 7. ERP Gynecology Oncology Pathway PowerPlan 8. ERP Whipple/Pancreas Pathway PowerPlan 9. ERP Open Liver Resection Pathway PowerPlan 10. Surgery is scheduled for one of the following UPMC sites: 11. UPMC Presbyterian Hospital 12. UPMC Passavant Hospital 13. UPMC Magee-Women's Hospital Exclusion Critera 1. Death is deemed to be imminent or inevitable 2. Patient is pregnant \< 18 years of age 3. Patients undergoing emergent/urgent surgery 4. Patients that are pregnant 5. Patients that have an eligible PowerPlan ordered less than one night before surgery

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 2500, 'type': 'ESTIMATED'}}

Updated at

2023-11-22

1 organization

8 products

1 indication

Organization

Jennifer Holder-Murray

Product

Neuraxial Analgesia

Indication

Perioperative Optimization

Product