EOIFP Block Versus OSTAP Block for Upper Abdominal Surgery (NCT06409156) | Clinical Trial Compass
RecruitingNot Applicable
EOIFP Block Versus OSTAP Block for Upper Abdominal Surgery
United States100 participantsStarted 2024-06-26
Plain-language summary
The investigators propose a single-center, assessor blinded, randomized control trial to compare the efficacy of external oblique fascial plane (EOIFP) block versus Oblique Subcostal Transversus Abdominis Plane (OSTAP) block for patients undergoing open upper abdominal surgery at Cleveland Clinic Main Campus.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent;
* 18-85 years old;
* ASA Physical Status 1-3
* Scheduled for elective open upper abdominal surgery with supraumbilical incision (gastrectomy, hepatectomy, pancreatectomy, splenectomy, supraumbilical ventral hernia repair).
* Anticipated hospitalization of three nights;
* Expected requirement for parenteral opioids for at least 48 hours for postoperative pain
Exclusion Criteria:
* Hepatic disease, e.g. twice the normal levels of liver enzymes;
* Chronic kidney disease according to GFR (may be stage 3 or worse as defined by a GFR \<60
* Allergic reaction to study medications;
* Women who are pregnant or breastfeeding;
* Nephrectomy or lower abdominal surgeries such as hysterectomy, colorectal surgeries
* Patient refusal
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is described as studying the 'learning curve' for a new nerve block technique called EOIFP — does that mean the doctors performing it are still developing their skills with it, and how might that affect my safety or pain control after surgery?
2How does the EOIFP block compare to the OSTAP block in terms of what's already known about pain relief for open abdominal surgery, and would either of these be better or worse than the pain management approach I'd get with standard care?
3Since this study is listed as 'Phase NA' and seems focused on whether the technique is feasible to learn rather than proving it works better, what does that mean for what I can realistically expect in terms of benefit versus uncertainty?
4What would my pain management plan look like if I join this trial versus if I don't — and are there proven alternatives I should consider first before enrolling in a study that's still evaluating a new technique?
5How much extra time, visits, or procedures would participating in this trial add to my recovery from open abdominal surgery, and what happens if the assigned block doesn't control my pain well enough?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
feasibility for the learning curve of EOIFP Vs OSTAP