EOIFP Block Versus OSTAP Block for Upper Abdominal Surgery

NCT ID: NCT06409156

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-26
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Open Abdominal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Oblique Subcostal Transversus Abdominis Plane Block

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.

Group Type: ACTIVE_COMPARATOR

Oblique Subcostal Transversus Abdominis Plane Block

Intervention Type: 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.

External Oblique Intercostal Fascial Plane block

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.

Group Type: EXPERIMENTAL

External Oblique Intercostal Fascial Plane block

Intervention Type: 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.

Interventions

Oblique Subcostal Transversus Abdominis Plane Block

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.

Intervention Type: PROCEDURE

External Oblique Intercostal Fascial Plane block

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.

Intervention Type: PROCEDURE

Other Intervention Names

OSTAP; EOIFP

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ehab Farag, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Fabio Rodriguez, MD

Role: CONTACT

rodrigf3@ccf.org

216-444-9950

Ehab Farag, MD

Role: CONTACT

farage@ccf.org

216 870-8719

Facility Contacts

Ehab Farag, MD

Role: primary

farage@ccf.org

Other Identifiers

23-417

Identifier Type: -

Identifier Source: org_study_id