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The Effect of Liposomal Bupivacaine Erector Spinae Plane Block

24. juni 2026 opdateret af: Second Affiliated Hospital, School of Medicine, Zhejiang University

The Effect of Liposomal Bupivacaine Erector Spinae Plane Block on Postoperative Pain in Patients Undergoing Open Upper Abdominal Surgery: A Randomized, Controlled, Double-Blind Trial

This is a single-center, randomized, controlled, double-blind clinical trial. A total of 148 patients undergoing elective open upper abdominal surgery will be included and randomly assigned 1:1 to receive ultrasound-guided erector spinae plane block with liposome bupivacaine plus bupivacaine hydrochloride or bupivacaine hydrochloride alone. The primary outcome is the AUC of resting pain scores from 0 to 72 hours postoperatively. This study aims to evaluate the analgesic efficacy and safety of liposome bupivacaine and provide a long-acting and safe postoperative analgesia strategy.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

148

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
      • Hangzhou, Kina
        • The Second Affiliated Hospital, Zhejiang University School of Medicine
        • Kontakt:
        • Kontakt:
          • Zhang Liang

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:

  1. Patients scheduled for elective open upper abdominal surgery, including open liver, gastric and pancreatic surgery.
  2. Patients receiving general anesthesia with tracheal intubation.
  3. Aged from 18 to 80 years old.
  4. Patients with American Society of Anesthesiologists (ASA) physical status class Ⅰ-Ⅲ.
  5. Patients who can understand the trial content, are willing to strictly follow the clinical research protocol and complete the trial, and voluntarily sign the informed consent form.

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. Patients complicated with severe primary diseases of the lung, liver, kidney, cardiovascular system and hematopoietic system.
  3. Bleeding tendency or coagulation dysfunction, defined as international normalized ratio (INR) ≥ 1.4, activated partial thromboplastin time > 38 s, or platelet count < 80×10⁹/L.
  4. Patients with aggravated cardiac diseases (complex congenital heart disease, heart failure and valvular disease) or pulmonary insufficiency.
  5. Skin infection at the puncture site for erector spinae plane block (ESPB).
  6. Previous history of neurological or psychiatric diseases, with inability to read, understand and communicate.
  7. Current obstructive or restrictive pulmonary disease.
  8. Patients with BMI greater than 30 kg/m².
  9. Drug abuse, long-term regular use of analgesics, or allergy to the study drugs.
  10. Patients who refuse to provide informed consent.
  11. Those enrolled in other randomized controlled trials simultaneously or with other conditions unsuitable for participation in this trial.

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
Eksperimentel: Liposomal Bupivacaine Combined Intervention Arm
Patients in this arm receive ultrasound-guided bilateral T7 erector spinae plane block with a mixed solution of liposomal bupivacaine and conventional bupivacaine hydrochloride, for postoperative analgesia after elective open upper abdominal surgery.
Medicin: Liposomal bupivacaine plus bupivacaine hydrochloride
This intervention uses a combination of liposomal bupivacaine and standard bupivacaine hydrochloride for T7 bilateral erector spinae plane block. The liposomal formulation provides prolonged local analgesic effect, which differentiates it from the control intervention that uses only conventional bupivacaine hydrochloride without long-acting liposomal components.
Aktiv komparator: Conventional Bupivacaine Single Agent Arm
Patients in this arm receive ultrasound-guided bilateral T7 erector spinae plane block with conventional bupivacaine hydrochloride alone for postoperative analgesia after elective open upper abdominal surgery.
Medicin: Bupivacaine hydrochloride monotherapy
This intervention adopts single-agent conventional bupivacaine hydrochloride for bilateral T7 erector spinae plane block, without adding liposomal bupivacaine. It serves as the conventional analgesia regimen and is different from the combined regimen supplemented with long-acting liposomal bupivacaine in the experimental group.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
AUC of resting pain score within 0-72 hours after operation
Tidsramme: Postoperative 0 to 72 hours
Calculate the area under the curve (AUC) of resting visual analog scale (VAS) pain scores at multiple time points within 0 to 72 hours after open upper abdominal surgery, to comprehensively evaluate the overall postoperative analgesic effect.
Postoperative 0 to 72 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative adverse reaction incidence
Tidsramme: Postoperative 0-72 hours
Observe and record the incidence of postoperative adverse reactions including nausea, vomiting, dizziness and neurological complications in all patients.
Postoperative 0-72 hours
Time to first ambulation
Tidsramme: Within 7 days after surgery
Record the time from the end of surgery to the first off-bed ambulation of patients.
Within 7 days after surgery
Postoperative hospital stay
Tidsramme: From the start of surgery to discharge, the average is ten days
Record the total length of postoperative hospital stay for each patient.
From the start of surgery to discharge, the average is ten days
Dynamic VAS pain score at each time point
Tidsramme: At 2, 6, 12, 24, 48, and 72 hours postoperatively.
Compare resting and dynamic Visual Analogue Scale (VAS) pain scores between the two groups. The VAS is a 10-cm scale ranging from 0 to 10, where 0 = no pain and 10 = worst possible pain (higher scores indicate worse outcomes).
At 2, 6, 12, 24, 48, and 72 hours postoperatively.
Dynamic VAS pain score at each time point
Tidsramme: Postoperative 2 hours (h), 6h, 12h, 24h, 48h, 72 hours (h)
Compare resting and dynamic VAS pain scores at postoperative 2h, 6h, 12h, 24h, 48h and 72h between two groups.
Postoperative 2 hours (h), 6h, 12h, 24h, 48h, 72 hours (h)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

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. juli 2026

Primær færdiggørelse (Anslået)

1. februar 2027

Studieafslutning (Anslået)

5. februar 2027

Datoer for studieregistrering

Først indsendt

24. maj 2026

Først indsendt, der opfyldte QC-kriterier

24. juni 2026

Først opslået (Faktiske)

25. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2026

Sidst verificeret

1. marts 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2024-1120

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