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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 - day 30
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

Find a Location

Who is running the clinical trial?

Jennifer Holder-MurrayLead Sponsor
Berry ConsultantsOTHER
14 Previous Clinical Trials
53,681 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there similar medical studies that have used Orthopedic: Preoperative Oral Analgesia Adjunct Gabapentin?

"At present, there are 332 ongoing studies studying Orthopedic: Preoperative Oral Analgesia Adjunct Gabapentin with 75 trials in Phase 3. Most of the clinical trials for Orthopedic: Preoperative Oral Analgesia Adjunct Gabapentin are based in Boston, Massachusetts, but there are 1485 locations operating studies for Orthopedic: Preoperative Oral Analgesia Adjunct Gabapentin."

Answered by AI

How many people are being introduced to this research?

"Unfortunately, this trial is not admitting patients at the moment. The listing was made on November 1st, 2020 but was edited most recently on August 5th, 2020. For those still interested in participating in studies, there are 1 clinical trials related to perioperative optimization and 332 trials for Orthopedic: Preoperative Oral Analgesia Adjunct Gabapentin currently admitting patients."

Answered by AI

What is Gabapentin commonly used as an adjunct for before surgery?

"Orthopedic: Preoperative Oral Analgesia Adjunct Gabapentin is commonly used as an intervention for cervical syndrome. Additionally, it has been used to minor burns, general anesthesia, and neuralgia."

Answered by AI

Is the FDA's blessing required for Orthopedic: Preoperative Oral Analgesia Adjunct Gabapentin ?

"There is some evidence to support the efficacy of Orthopedic: Preoperative Oral Analgesia Adjunct Gabapentin, so it received a score of 3."

Answered by AI

Are enrollees still being sought for this research project?

"Although this particular clinical trial is not looking for new candidates, it's important to note that there are other 333 medical studies currently enrolling patients. This specific trial was posted on November 1st, 2020 and was last updated on August 5th, 2020."

Answered by AI
~1053 spots leftby Dec 2024