Recommendations of Enhanced Recovery Interventions for Patient's Clinical Team and Collection of Associated Data
NCT04606264 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2977
Last updated 2025-10-17
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.
Conditions
- Perioperative Optimization
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
-
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)
Sponsors & Collaborators
-
Berry Consultants
collaborator OTHER -
Jennifer Holder-Murray
lead OTHER
Principal Investigators
-
Stephen Esper, MD, MBA · University of Pittsburgh
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-15
- Primary Completion
- 2025-03-21
- Completion
- 2025-03-21
- FDA Drug
- Yes
Countries
- United States
Study Locations
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