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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
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 - day 30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 - day 30
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
30 day hospital free days
Secondary outcome measures
Nausea
Change in the rate of postoperative opioid use by measurement of oral morphine equivalents (OME) postoperative day 0 to postoperative day 1
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
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had emergency surgery without prior notice.I have not been part of this study or had surgery at UPMC in the last month.My upcoming surgery will follow an Enhanced Recovery Pathway.I have a preoperative appointment before my surgery.You are currently pregnant.The participant is expected to pass away very soon, and there is nothing that can be done to prevent it.
Research Study Groups:
This trial has the following groups:- Group 1: Major Abdominal: Neuraxial Analgesia
- Group 2: Major Abdominal: Regional Analgesia Block 1
- Group 3: Major Abdominal: PONV Optimal Prophylaxis
- Group 4: Major Abdominal: PONV Supraoptimal Prophylaxis
- Group 5: Major Abdominal: Regional Analgesia Block 2
- Group 6: Major Abdominal: Neuraxial and Regional Analgesia Block 2
- Group 7: Major Abdominal: Neuraxial and Regional Analgesia Block 1
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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