EOIFP Block Versus OSTAP Block for Upper Abdominal Surgery

NCT06409156 | Recruiting DMC

• 1 other identifier: 23-417
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Open Abdominal Surgery

Keywords

Abdominal Block

Outcome Measures

Primary Outcomes (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

  3 days

Study Arms (2)

Oblique Subcostal Transversus Abdominis Plane Block

ACTIVE COMPARATOR

Researchers 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.

Procedure: Oblique Subcostal Transversus Abdominis Plane Block

External Oblique Intercostal Fascial Plane block

EXPERIMENTAL

Researchers 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.

Procedure: External Oblique Intercostal Fascial Plane block

Interventions

External Oblique Intercostal Fascial Plane block PROCEDURE

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.

Also known as: EOIFP

External Oblique Intercostal Fascial Plane block

Oblique Subcostal Transversus Abdominis Plane Block PROCEDURE

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.

Also known as: OSTAP

Oblique Subcostal Transversus Abdominis Plane Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent;
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Study Officials

• Ehab Farag, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Rodriguez, MD

CONTACT

216-444-9950; rodrigf3@ccf.org

Ehab Farag, MD

CONTACT

216 870-8719; farage@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant and Outcomes Assessor will be blinded to the patient's allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center randomized control trial

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: June 26, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)