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Open Abdominal SurgeryNCT06409156

EOIFP Block Versus OSTAP Block for Upper Abdominal Surgery

A study testing Oblique Subcostal Transversus Abdominis Plane Block and External Oblique Intercostal Fascial Plane block in people with Open Abdominal Surgery, run by The Cleveland Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Open Abdominal Surgery
What is being tested?
Oblique Subcostal Transversus Abdominis Plane Block and External Oblique Intercostal Fascial Plane block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
26 Jun 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fabio Rodriguez, MD contact

216-444-9950

rodrigf3@ccf.org

Ehab Farag, MD contact

216 870-8719

farage@ccf.org

United States1 site, 1 recruiting
  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Ehab Farag, MD, farage@ccf.org

    Recruiting

Other trials in United States

About this study

Official title: A Feasibility Pilot Study Assessing the Effects of External Oblique Intercostal Fascial Plane Block Versus Subcostal TAP Block for Upper Abdominal Surgery: A Randomized, Controlled Trial

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.

Read the detailed description

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..

Participating patients and outcome assessors will be blinded to group assignment. The anesthesiologists who perform the blocks will not be blinded to group assignment.

American Society of Anesthesiologists (ASA) physical status 1-3 adults scheduled for elective open upper abdominal surgery with supraumbilical incision, with anticipated 3 days postoperative hospitalization, at Cleveland Clinic Main Campus will be included in the study. Patients will be excluded if they have chronic hepatic or kidney disease. Pregnant or breastfeeding participants will not be eligible for this study.

Patients will be randomly assigned to: 1) EOIFP block or 2) OSTAP block. The location of each block will be performed as previously described. The procedure will be performed using sterile technique under ultrasound guidance. Once the target is visualized, a 20-gauge, 4-inch echogenic needle will be advanced in-plane to the fascial plane. 5 ml of 0.9% normal saline will be injected through the needle to open the fascial plane and then a single dose (10 ml) of liposomal bupivacaine mixed with 20 mL of bupivacaine 0.25% will be injected on each side. General anesthesia will be induced at the attending anesthesiologist's discretion and maintained with sevoflurane or isoflurane. Intraoperative analgesic use will be up to the anesthesiologist preference. Postoperatively, patients will be given IV Dilaudid \&/or fentanyl, \&/or morphine equivalent for pain relief as needed, as well as oral Tylenol 1000mg every 8 hours unless contraindicated. Toradol can be given as part of multimodal analgesia if cleared by the surgical team. Clinicians will adjust analgesic management as necessary in an effort to keep verbal response pain scores <4. Nurses will adjust analgesic management as necessary in an effort to keep verbal response pain scores <4.

Other anti-inflammatory drugs will not be used intraoperatively or for the initial 48 postoperative hours. A single dose of dexamethasone (4-8 mg) will be permitted for PONV prophylaxis for patients with Apfel risk score of 2 or more, and inhaled steroids will be permitted as necessary to treat reactive airway disease. Other opioid sparing medications like gabapentin, pregabalin, ketamine or lidocaine patch will also not be permitted through the initial 48 postoperative hours.

Clinical evaluators for the outcomes will be blinded to study aim and Pharmacy personnel not involved in evaluations will prepare the study drugs. Patients will be continuously monitored and recorded with a wireless monitor starting after extubation in the operating room. Clinicians including nurses will be blinded to monitoring and will be required to perform their standard of care management after surgery.

Patients will be allowed to receive prophylactic anti-emetic (first choice ondansetron) intraoperatively based on the risk assessment for nausea and vomiting. Postoperative anti-emetics for symptomatic treatment will also be allowed.

Being tested
Oblique Subcostal Transversus Abdominis Plane Block, External Oblique Intercostal Fascial Plane block
Keywords
Abdominal Block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oblique Subcostal Transversus Abdominis Plane BlockProcedure or surgery

    Also called OSTAP

    With the OSTAP block, local anesthetic is injected into the fascial plane between the posterior rectus sheath and the transversus abdominis muscle beneath the subcostal margin.

  • External Oblique Intercostal Fascial Plane blockProcedure or surgery

    Also called EOIFP

    With the EOIF block, local anesthetic targets the terminal part of the thoracoabdominal nerves pass behind the costal cartilage and continue anteriorly in the plane between the internal oblique and transversus abdominis muscle, before piercing the rectus abdominis sheath as anterior cutaneous branches supplying the skin of the midabdomen.

Study groups in NCT06409156
Study groupRoleWhat they receive
Oblique Subcostal Transversus Abdominis Plane BlockActive comparatorResearchers will perform the Oblique Subcostal Transversus Abdominis Plane Block using sterile technique under ultrasound guidance. Once the target is visualized, a 20-gauge, 4-inch echogenic needle will be advanced in-plane to the fascial plane. 5 ml of 0.9% normal saline will be injected through the needle to open the fascial plane and then a single dose (10 ml) of liposomal bupivacaine mixed with 20 mL of bupivacaine 0.25% will be injected on each side.
Receives: Procedure: Oblique Subcostal Transversus Abdominis Plane Block
External Oblique Intercostal Fascial Plane blockExperimentalResearchers will perform the External Oblique Intercostal Fascial Plane block using sterile technique under ultrasound guidance. Once the target is visualized, a 20-gauge, 4-inch echogenic needle will be advanced in-plane to the fascial plane. 5 ml of 0.9% normal saline will be injected through the needle to open the fascial plane and then a single dose (10 ml) of liposomal bupivacaine mixed with 20 mL of bupivacaine 0.25% will be injected on each side.
Receives: Procedure: External Oblique Intercostal Fascial Plane block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. feasibility for the learning curve of EOIFP Vs OSTAP

    Evaluate feasibility for the learning curve of the new technique of EOIFP versus the standard technique of OSTAP

    Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2024
  2. Study start26 Jun 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single center randomized control trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06409156
Sponsor's protocol ID
23-417
Status last verified
Mar 2026
First submitted
7 May 2024
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Oblique Subcostal Transversus Abdominis Plane Block and External Oblique Intercostal Fascial Plane block in people with Open Abdominal Surgery, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fabio Rodriguez, MD (216-444-9950, rodrigf3@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

feasibility for the learning curve of EOIFP Vs OSTAP (time frame: 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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