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Behavioural Intervention

Enhanced Recovery Protocols for Perioperative Optimization

Phase 3
Recruiting
Research Sponsored by Jennifer Holder-Murray
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has been scheduled for a surgical type in which ERP has been implemented.
Be older than 18 years old
Must not have
Emergency surgical procedure without suitable lead-in time
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 - day 30
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is looking at ways to improve patient outcomes by testing different combinations of care before, during, and after surgery.

Who is the study for?
This trial is for patients at UPMC scheduled for elective surgery where Enhanced Recovery Protocols (ERP) are used. They must have a preoperative appointment before surgery. It's not for emergency surgeries, those who've been in this REMAP study or had surgery at UPMC within the last month, or pregnant individuals.
What is being tested?
The study tests different combinations of standard care treatments to enhance recovery around the time of surgery. This includes various medications and regional anesthesia techniques aimed at reducing hospital stays, nausea/vomiting after surgery, and improving pain management.
What are the potential side effects?
Possible side effects from interventions may include discomfort or complications from regional anesthesia, allergic reactions to medications, dizziness or sedation from anti-nausea drugs, and potential blood sugar changes due to steroids like Dexamethasone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My upcoming surgery will follow an Enhanced Recovery Pathway.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I had emergency surgery without prior notice.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 - day 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 - day 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
30 day hospital free days
Secondary study objectives
Nausea
Change in the rate of postoperative opioid use by measurement of oral morphine equivalents (OME) postoperative day 0 to postoperative day 1

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

7Treatment groups
Active Control
Group I: Major Abdominal: Neuraxial AnalgesiaActive Control1 Intervention
Intrathecal morphine
Group II: Major Abdominal: Regional Analgesia Block 1Active Control1 Intervention
Paravertebral block
Group III: Major Abdominal: PONV Optimal ProphylaxisActive Control3 Interventions
Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron
Group IV: Major Abdominal: PONV Supraoptimal ProphylaxisActive Control5 Interventions
Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron
Group V: Major Abdominal: Regional Analgesia Block 2Active Control1 Intervention
QL1
Group VI: Major Abdominal: Neuraxial and Regional Analgesia Block 2Active Control2 Interventions
IT morphine and QL1
Group VII: Major Abdominal: Neuraxial and Regional Analgesia Block 1Active Control2 Interventions
IT morphine and paravertebral

Find a Location

Who is running the clinical trial?

Jennifer Holder-MurrayLead Sponsor
Berry ConsultantsOTHER
14 Previous Clinical Trials
55,431 Total Patients Enrolled
Stephen Esper, MD, MBAStudy ChairUniversity of Pittsburgh
1 Previous Clinical Trials
15 Total Patients Enrolled

Media Library

Recommendations of Enhanced Recovery Interventions (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04606264 — Phase 3
Perioperative Optimization Research Study Groups: Major Abdominal: Neuraxial Analgesia, Major Abdominal: Regional Analgesia Block 1, Major Abdominal: PONV Optimal Prophylaxis, Major Abdominal: PONV Supraoptimal Prophylaxis, Major Abdominal: Regional Analgesia Block 2, Major Abdominal: Neuraxial and Regional Analgesia Block 2, Major Abdominal: Neuraxial and Regional Analgesia Block 1
Perioperative Optimization Clinical Trial 2023: Recommendations of Enhanced Recovery Interventions Highlights & Side Effects. Trial Name: NCT04606264 — Phase 3
Recommendations of Enhanced Recovery Interventions (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04606264 — Phase 3
~625 spots leftby Jun 2025
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