- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07615231
EOI Block vs. TAP Block in Minimally Invasive Hepatectomy (EOIvsTAP)
4. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
[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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
140
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Hyun-Kyu Yoon
- Telefonnummer: +82-2-2072-2467
- E-Mail: warren83@snu.ac.kr
Studieren Sie die Kontaktsicherung
- Name: wooyoung jo
- Telefonnummer: 01079333021
- E-Mail: jowoo345@naver.com
Studienorte
-
-
-
Seoul, Südkorea, 03080
- SNUH
-
Kontakt:
- Hyun-Kyu Yoon
- Telefonnummer: +82-2-2072-2467
- E-Mail: warren83@snu.ac.kr
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Aktiver Komparator: Transversus Abdominis Plane (TAP) block group
Patients who receive TAP 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Cumulative opioid consumption at 24 hours postoperatively
Zeitfenster: From the end of surgery up to 24 hours postoperatively
|
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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Cumulative Opioid Consumption at 1, 6, 12, and 48 hours postoperatively
Zeitfenster: 1, 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.
|
1, 6, 12, and 48 hours after surgery completion.
|
|
Postoperative pain intensity measured by Numerical Rating Scale (NRS)
Zeitfenster: 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."
|
During Post-Anesthesia Care Unit (PACU) stay, and at 24 and 48 hours postoperatively.
|
|
Total dose of intraoperative remifentanil
Zeitfenster: During the intraoperative period (from induction to skin closure).
|
Total administered dose of intraoperative remifentanil (mcg) measured from anesthesia induction to skin closure.
|
During the intraoperative period (from induction to skin closure).
|
|
Incidence of Postoperative Nausea and Vomiting
Zeitfenster: Up to 48 hours postoperatively.
|
The presence or absence of postoperative nausea and vomiting episodes (dichotomous outcome: yes/no) will be recorded.
|
Up to 48 hours postoperatively.
|
|
Time to first ambulation
Zeitfenster: From 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.
|
From the end of surgery up to 48 hours postoperatively (or until the first occurrence).
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Studienstuhl: Hyun-Kyu Yoon, MD/PhD, Seoul National University Hospital
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Juni 2026
Primärer Abschluss (Geschätzt)
31. Mai 2027
Studienabschluss (Geschätzt)
30. Juni 2027
Studienanmeldedaten
Zuerst eingereicht
22. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
22. Mai 2026
Zuerst gepostet (Tatsächlich)
29. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
4. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 2512-081-1703
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur External Oblique Intercostal Block
-
Halil Ibrahim AltunRekrutierung
-
Cairo UniversityRekrutierungBrustkrebs | Postoperative Schmerzen | Akuter postoperativer SchmerzÄgypten
-
Abant Izzet Baysal UniversityIstanbul Medipol University Hospital; Karabuk Training and Research Hospital; Çam...Noch keine RekrutierungPostoperative Schmerzen | Postoperative Schmerzen | BrustschmerzenTürkei (türkiye)
-
Engin ÇetinRekrutierungOpioidgebrauch | Postoperative SchmerzenTürkei (türkiye)
-
Engin ÇetinNoch keine RekrutierungPostoperative Schmerzen | OpioidgebrauchTürkei (türkiye)
-
Ankara City Hospital BilkentAbgeschlossenPostoperative Schmerztherapie | Minimalinvasive Herzchirurgie | Herzklappenerkrankung | Serratus Posterior Superior Intercostal Plane BlockTürkei (türkiye)
-
Koç UniversityRekrutierungRegionalanästhesie-Morbidität | Videoassistierte Thorakoskopische Chirurgie | Paravertebraler Block | Serratus Posterior Superior Intercostal Plane BlockTruthahn
-
Taichung Veterans General HospitalRekrutierung
-
Hitit UniversityAbgeschlossen
-
Uludag UniversityNoch keine Rekrutierung