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EOI Block vs. TAP Block in Minimally Invasive Hepatectomy

External Oblique Intercostal Plane Block and Subcostal Transversus Abdominis Plane Block in Minimally Invasive Hepatectomy: Non-inferiority Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07615231
Acronym
EOIvsTAP
Enrollment
140
Registered
2026-05-29
Start date
2026-06-01
Completion date
2027-06-30
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatectomy

Keywords

minimally invasive hepatectomy, TAP block, EOI block

Brief summary

This study aims to compare the analgesic efficacy of two different ultrasound-guided nerve blocks-the External Oblique Intercostal (EOI) block and the Subcostal Transversus Abdominis Plane (TAP) block-in patients undergoing minimally invasive hepatectomy. All participants will receive standardized general anesthesia and perioperative care at Seoul National University Hospital. Following anesthesia induction, patients will be randomly assigned to receive either an EOI block or a subcostal TAP block with 0.375% ropivacaine to provide regional pain relief. Postoperative pain will be managed using a combination of scheduled non-opioid analgesics and a fentanyl-based patient-controlled analgesia (PCA) device. The primary objective is to evaluate which regional technique more effectively reduces cumulative opioid consumption during the first 24 hours after surgery. Additionally, the study will assess pain intensity using the Numerical Rating Scale (NRS), the incidence of postoperative nausea and vomiting, and the overall recovery profile, including the time to first ambulation.

Detailed description

\[Anesthesia and Induction\] Except for the specific nerve block technique assigned to each group, all participants will receive the standard anesthetic care for minimally invasive hepatectomy at Seoul National University Hospital. No premedication will be administered before entering the operating room, where standard non-invasive monitoring will be established. Anesthesia will be induced with remifentanil target-controlled infusion, propofol, and rocuronium after loss of consciousness. Endotracheal intubation will be performed after neuromuscular blockade. Anesthesia will be maintained with desflurane and remifentanil infusion, adjusted according to clinical requirements. As a part of the perioperative care, palonosetron (0.075 mg) and dexamethasone (5 mg) will be given intravenously during induction for antiemetic prophylaxis, and intravenous acetaminophen (1 g) and nefopam (20 mg) will be administered before the start of surgery. \[Interventional Procedures\] Following the induction of anesthesia, all nerve blocks will be performed under ultrasound guidance using a high-frequency convex probe covered with a sterile sheath under aseptic conditions. For the External Oblique Intercostal (EOI) block group, the T10 rib will be located at the intersection of the midclavicular line and the umbilical line, and the clinician will count upwards to identify the T6, T7, and T8 ribs. The probe will then be placed perpendicular to the rib trajectory at the T6-7 or T7-8 intercostal space to identify the external intercostal plane. Using an in-plane approach with an 8-cm needle, the plane will be confirmed via hydrodissection with 1-2 mL of saline, followed by the bilateral injection of 20 mL of 0.375% ropivacaine per side (total 40 mL). In contrast, for the Subcostal Transversus Abdominis Plane (TAP) block group, the probe will be placed on the subxiphoid midline and moved laterally along the T12 rib to identify the transversus abdominis plane. The needle will be advanced to the plane between the internal oblique and transversus abdominis muscles, and similarly, 20 mL of 0.375% ropivacaine will be injected into each side (total 40 mL) after confirming the plane with saline. \[Postoperative Analgesia and Outcomes\] Postoperative pain will be managed primarily using a fentanyl-based patient-controlled analgesia (PCA) device (Accumate 1200, Woo Young Medical), set with a loading dose of 50 mcg, a demand-only bolus of 20 mcg, and a 10-minute lockout time without basal infusion. A scheduled non-opioid regimen, consisting of intravenous acetaminophen (1 g) and nefopam (20 mg) every 8 hours, will be maintained for 48 hours, transitioning to oral acetaminophen (650 mg) once oral intake resumes. In the Post-Anesthesia Care Unit (PACU), if a patient reports a Numerical Rating Scale (NRS) score of 7 or higher despite active PCA use (exceeding four times per hour), a rescue dose of 50 mcg of intravenous fentanyl will be provided.

Interventions

Following the induction of general anesthesia, patients in this group will receive an ultrasound-guided bilateral external intercostal fascial plane block. A total of 40 mL of 0.375% ropivacaine (20 mL per side) will be injected into the plane between the external intercostal muscle and the internal intercostal muscle at the T6-7 or T7-8 level.

PROCEDURETAP Block

Following the induction of general anesthesia, patients in this group will receive an ultrasound-guided bilateral subcostal transversus abdominis plane block. A total of 40 mL of 0.375% ropivacaine (20 mL per side) will be injected into the fascial plane between the internal oblique and transversus abdominis muscles along the subcostal margin.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Scheduled to undergo elective robotic or laparoscopic minimally invasive hepatectomy

Exclusion criteria

* American Society of Anesthesiologists physical status IV or higher * History of chronic pain or current use of analgesics, antidepressants, or anticonvulsants for pain management * Known hypersensitivity to general anesthetics, opioids, or local anesthetics * Conversion to open hepatectomy * Requirement for mechanical ventilation for more than 2 hours within 48 hours postoperatively * Any other clinical condition that makes the patient unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frameDescription
Cumulative opioid consumption at 24 hours postoperativelyFrom the end of surgery up to 24 hours postoperativelyThe total amount of intravenous fentanyl administered via patient-controlled analgesia (PCA) and as rescue boluses will be recorded and converted to intravenous morphine equivalents for standardized comparison.

Secondary

MeasureTime frameDescription
Cumulative Opioid Consumption at 1, 6, 12, and 48 hours postoperatively1, 6, 12, and 48 hours after surgery completion.Total amount of fentanyl administered via IV-PCA and rescue boluses. All doses will be recorded and analyzed at each specified time point.
Postoperative pain intensity measured by Numerical Rating Scale (NRS)During Post-Anesthesia Care Unit (PACU) stay, and at 24 and 48 hours postoperatively.Pain intensity is assessed using a scale from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst pain imaginable."
Total dose of intraoperative remifentanilDuring the intraoperative period (from induction to skin closure).Total administered dose of intraoperative remifentanil (mcg) measured from anesthesia induction to skin closure.
Incidence of Postoperative Nausea and VomitingUp to 48 hours postoperatively.The presence or absence of postoperative nausea and vomiting episodes (dichotomous outcome: yes/no) will be recorded.
Time to first ambulationFrom the end of surgery up to 48 hours postoperatively (or until the first occurrence).The time interval (hours) from the end of surgery until the patient first successfully achieves independent or assisted walking.

Countries

South Korea

Contacts

CONTACTHyun-Kyu Yoon
warren83@snu.ac.kr+82-2-2072-2467
CONTACTwooyoung jo
jowoo345@naver.com01079333021
STUDY_CHAIRHyun-Kyu Yoon, MD/PhD

Seoul National University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026