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- Klinische proef NCT07642336
Erector Spinae Plane Block Versus Thoracic Epidural Analgesia for Open Liver Resection
17 augustus 2026 bijgewerkt door: Nguyen Toan Thang
Comparison of Postoperative Analgesic Efficacy Between Erector Spinae Plane Block and Thoracic Epidural Analgesia in Open Hepatectomy: A Randomized Controlled Trial
Background: Open liver resection is associated with severe postoperative pain.
While thoracic epidural analgesia (TEA) is considered the gold standard for pain control, its clinical application is often limited by postoperative coagulation profile derangement, which increases the risk of epidural hematoma.
Continuous erector spinae plane block (ESPB) has emerged as a promising, safer alternative with a lower risk of bleeding complications.
Objective: This study aims to compare the postoperative analgesic efficacy, safety profiles, and impacts on respiratory function between ultrasound-guided continuous ESPB and TEA in patients undergoing elective open liver resection.
Hypothesis: The investigators hypothesize that continuous ESPB using a programmed intermittent bolus (PIB) regimen is non-inferior to TEA regarding 72-hour postoperative pain scores at rest, while offering superior hemodynamic stability and fewer technique-related risks.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
This is a randomized, controlled, parallel-group, non-inferiority clinical trial conducted at Bach Mai Hospital.
Eligible patients scheduled for elective open liver resection will be randomly allocated into one of two groups at a 1:1 ratio: 1. ESPB Group (n = 30): Patients will receive bilateral erector spinae plane catheters placed at the T7 level under ultrasound guidance prior to anesthesia induction.
A bolus of 20 mL Ropivacaine 0.2% will be administered on each side.
Postoperative analgesia will be maintained for 72 hours using a Programmed Intermittent Bolus (PIB) regimen of Ropivacaine 0.1%: 20 mL every 3 hours on the right side and 20 mL every 3 hours on the left side.
2. TEA Group (n = 30): Patients will receive a thoracic epidural catheter inserted at the T7-T8 interspace.
An initial bolus of 10 mL Ropivacaine 0.2% will be given, followed by a continuous basal infusion of Ropivacaine 0.1% at 5-8 mL/h for 72 hours.
Multimodal Analgesia: All patients in both groups will receive a standardized general anesthesia protocol and systemic multimodal analgesia, including intravenous paracetamol (1 g every 6 hours) and nefopam (20 mg every 6 hours).
Outcomes Evaluation: The primary outcome is the postoperative pain intensity measured by the Numerical Rating Scale (NRS) at rest 24 hours after surgery.
Secondary outcomes include NRS pain scores at rest and during coughing at multiple time points up to 72 hours, cumulative 24-hour morphine consumption, hemodynamic parameters, and incidence of adverse events (e.g., hypotension, postoperative nausea and vomiting, hematoma, or catheter failure)
Studietype
Ingrijpend
Inschrijving (Werkelijk)
63
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Kim Lien
-
Hà Nội, Kim Lien, Vietnam
- Department of Anesthesiology and Resuscitation, Bach Mai Hospital
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
* Patients aged between 18 and 80 years old.
- American Society of Anesthesiologists (ASA) physical status classification I to III.
- Scheduled to undergo elective open liver resection (open hepatectomy).
- Patient provides written informed consent to participate in the study.
Exclusion Criteria:
Severe coagulation profile derangement prior to surgery (defined as International Normalized Ratio [INR] > 1.5 or 2.0, or Platelet count [PLT] < 50 G/L or 100 G/L).
- Severe hepatic impairment (Child-Pugh Class C).
- Severe chronic obstructive pulmonary disease (COPD GOLD stage III-IV).
- Severe cardiac dysfunction with an ejection fraction (EF) < 35%.
- Severe obesity with a Body Mass Index (BMI) > 40 kg/m².
- Localized infection at the planned puncture/needle insertion site.
- Known allergy or hypersensitivity to local anesthetics (e.g., Ropivacaine) or opioids (e.g., Morphine).
- Pregnancy or current lactation.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Erector Spinae Plane Block Group
Patients will receive ultrasound-guided continuous bilateral erector spinae plane block at the T7 level with a programmed intermittent bolus (PIB) regimen of Ropivacaine 0.1% (18 mL/3h on the right side and 18 mL/3h on the left side) for 72 hours postoperatively, combined with systemic multimodal analgesia
|
Patients will receive ultrasound-guided continuous bilateral erector spinae plane block at the T7 level with a programmed intermittent bolus (PIB) regimen of Ropivacaine 0.1% (18 mL/3h on the right side and 18 mL/3h on the left side) for 72 hours postoperatively, combined with systemic multimodal analgesia
|
|
Actieve vergelijker: Thoracic Epidural Analgesia Group
Patients will receive a thoracic epidural catheter inserted at the T7-T8 interspace with a continuous basal infusion of Ropivacaine 0.1% at a rate of 5-8 mL/h for 72 hours postoperatively, combined with systemic multimodal analgesia
|
Patients will receive a thoracic epidural catheter inserted at the T7-T8 interspace with a continuous basal infusion of Ropivacaine 0.1% at a rate of 5-8 mL/h for 72 hours postoperatively, combined with systemic multimodal analgesia
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Postoperative Pain Intensity at Rest at 24 Hours
Tijdsspanne: At 24 hours postoperatively
|
Postoperative pain intensity evaluated using the Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst imaginable pain.
The score will be recorded at rest exactly 24 hours after the completion of the surgery
|
At 24 hours postoperatively
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Cumulative Morphine Equivalent Consumption
Tijdsspanne: From 0 to 24 hours postoperatively
|
The total amount of intravenous morphine equivalents (in milligrams) administered as rescue analgesia to the patient during the first 24 hours after surgery
|
From 0 to 24 hours postoperatively
|
|
Postoperative Pain Intensity at Rest and During Coughing up to 72 Hours
Tijdsspanne: At 0, 1, 3, 6, 12, 48, and 72 hours postoperatively
|
Pain intensity scores assessed using the Numerical Rating Scale (NRS, 0-10) both at rest and during coughing at multiple scheduled postoperative time intervals
|
At 0, 1, 3, 6, 12, 48, and 72 hours postoperatively
|
|
Incidence of Postoperative Complications and Adverse Events
Tijdsspanne: Up to 72 hours postoperatively
|
The percentage of patients experiencing technique-related complications (such as local hematoma, catheter dislodgement, block failure) or opioid-related side effects (including postoperative nausea and vomiting, pruritus, urinary retention), as well as pulmonary complications (atelectasis, pneumonia) and hemodynamic instability (hypotension, bradycardia)
|
Up to 72 hours postoperatively
|
|
Time to Gastrointestinal Recovery
Tijdsspanne: Up to 72 hours postoperatively
|
Evaluation of bowel function recovery, measured by the time (in hours) from the end of surgery to the first passage of flatus (first anal exhaust), and the time (in hours) to the first tolerance of oral intake (solid or liquid food)
|
Up to 72 hours postoperatively
|
|
First Postoperative Night Sleep Quality
Tijdsspanne: On the first postoperative night
|
The patient's subjective sleep quality during the first night after surgery, evaluated using a visual analog scale (VAS for sleep) or the Pittsburgh Sleep Quality Index (PSQI) subscale, where sleep disruption and total sleep duration are assessed
|
On the first postoperative night
|
|
Postoperative Length of Hospital Stay
Tijdsspanne: From the day of surgery to hospital discharge (estimated up to 14 days)
|
The total number of days from the completion of the surgical procedure to the day the patient is officially discharged from the hospital, meeting predefined standard discharge criteria
|
From the day of surgery to hospital discharge (estimated up to 14 days)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
15 juni 2026
Primaire voltooiing (Werkelijk)
15 augustus 2026
Studie voltooiing (Werkelijk)
15 augustus 2026
Studieregistratiedata
Eerst ingediend
8 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
8 juni 2026
Eerst geplaatst (Werkelijk)
11 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
17 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pijn
- Neurologische manifestaties
- Postoperatieve complicaties
- Pathologische processen
- Neoplasmata per site
- Neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Ziekten van het spijsverteringsstelsel
- Lever Ziekten
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Pijn, postoperatief
- Acute pijn
- Lever neoplasmata
- Dieet, voedsel en voeding
- Fysiologische fenomenen
- Eten en dranken
- Dranken
- Plantenbereidingen
- Biologische producten
- Complexe mengsels
- Thee
Andere studie-ID-nummers
- IRB-BMH-ĐT.RG-2026.12.Đ11
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
The individual patient data will not be shared publicly to maintain patient confidentiality and privacy in accordance with local institutional regulations.
The aggregated results will be published in the final thesis and scientific journals
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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