- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07615231
EOI Block vs. TAP Block in Minimally Invasive Hepatectomy (EOIvsTAP)
4. juni 2026 opdateret af: Hyun-Kyu Yoon, Seoul National University Hospital
External Oblique Intercostal Plane Block and Subcostal Transversus Abdominis Plane Block in Minimally Invasive Hepatectomy: Non-inferiority Trial
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
[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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
140
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Hyun-Kyu Yoon
- Telefonnummer: +82-2-2072-2467
- E-mail: warren83@snu.ac.kr
Undersøgelse Kontakt Backup
- Navn: wooyoung jo
- Telefonnummer: 01079333021
- E-mail: jowoo345@naver.com
Studiesteder
-
-
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Seoul, Sydkorea, 03080
- SNUH
-
Kontakt:
- Hyun-Kyu Yoon
- Telefonnummer: +82-2-2072-2467
- E-mail: warren83@snu.ac.kr
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: External Oblique Intercostal (EOI) block group
patients who receive EOI block
|
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.
|
|
Aktiv komparator: Transversus Abdominis Plane (TAP) block group
Patients who receive TAP block
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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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cumulative opioid consumption at 24 hours postoperatively
Tidsramme: From the end of surgery up to 24 hours postoperatively
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The 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.
|
From the end of surgery up to 24 hours postoperatively
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cumulative Opioid Consumption at 1, 6, 12, and 48 hours postoperatively
Tidsramme: 1, 6, 12, and 48 hours after surgery completion.
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Total amount of fentanyl administered via IV-PCA and rescue boluses.
All doses will be recorded and analyzed at each specified time point.
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1, 6, 12, and 48 hours after surgery completion.
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Postoperative pain intensity measured by Numerical Rating Scale (NRS)
Tidsramme: During Post-Anesthesia Care Unit (PACU) stay, and at 24 and 48 hours postoperatively.
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Pain intensity is assessed using a scale from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst pain imaginable."
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During Post-Anesthesia Care Unit (PACU) stay, and at 24 and 48 hours postoperatively.
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Total dose of intraoperative remifentanil
Tidsramme: During the intraoperative period (from induction to skin closure).
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Total administered dose of intraoperative remifentanil (mcg) measured from anesthesia induction to skin closure.
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During the intraoperative period (from induction to skin closure).
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Incidence of Postoperative Nausea and Vomiting
Tidsramme: Up to 48 hours postoperatively.
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The presence or absence of postoperative nausea and vomiting episodes (dichotomous outcome: yes/no) will be recorded.
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Up to 48 hours postoperatively.
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Time to first ambulation
Tidsramme: From the end of surgery up to 48 hours postoperatively (or until the first occurrence).
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The time interval (hours) from the end of surgery until the patient first successfully achieves independent or assisted walking.
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From the end of surgery up to 48 hours postoperatively (or until the first occurrence).
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Hyun-Kyu Yoon, MD/PhD, Seoul National University Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
31. maj 2027
Studieafslutning (Anslået)
30. juni 2027
Datoer for studieregistrering
Først indsendt
22. maj 2026
Først indsendt, der opfyldte QC-kriterier
22. maj 2026
Først opslået (Faktiske)
29. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2512-081-1703
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Deidentified individual participant data and a data dictionary will be made available to researchers for specified analyses upon reasonable request to the corresponding author via email.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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