- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07615231
EOI Block vs. TAP Block in Minimally Invasive Hepatectomy (EOIvsTAP)
4. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
140
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Hyun-Kyu Yoon
- Telefonnummer: +82-2-2072-2467
- E-post: warren83@snu.ac.kr
Studer Kontakt Backup
- Navn: wooyoung jo
- Telefonnummer: 01079333021
- E-post: jowoo345@naver.com
Studiesteder
-
-
-
Seoul, Sør -Korea, 03080
- SNUH
-
Ta kontakt med:
- Hyun-Kyu Yoon
- Telefonnummer: +82-2-2072-2467
- E-post: warren83@snu.ac.kr
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cumulative opioid consumption at 24 hours postoperatively
Tidsramme: 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.
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From the end of surgery up to 24 hours postoperatively
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: Hyun-Kyu Yoon, MD/PhD, Seoul National University Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
31. mai 2027
Studiet fullført (Antatt)
30. juni 2027
Datoer for studieregistrering
Først innsendt
22. mai 2026
Først innsendt som oppfylte QC-kriteriene
22. mai 2026
Først lagt ut (Faktiske)
29. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2512-081-1703
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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