The Effect of Liposomal Bupivacaine Erector Spinae Plane Block
24 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
148
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Zhang Liang
- Telefonnummer: 15858281360
- E-post: keyanlunli_zheer@163.com
Studieorter
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-
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Hangzhou, Kina
- The Second Affiliated Hospital, Zhejiang University School of Medicine
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Kontakt:
- Zhang
- E-post: keyanlunli_zheer@163.com
-
Kontakt:
- Zhang Liang
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Patients scheduled for elective open upper abdominal surgery, including open liver, gastric and pancreatic surgery.
- Patients receiving general anesthesia with tracheal intubation.
- Aged from 18 to 80 years old.
- Patients with American Society of Anesthesiologists (ASA) physical status class Ⅰ-Ⅲ.
- 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:
- Pregnant or lactating women.
- Patients complicated with severe primary diseases of the lung, liver, kidney, cardiovascular system and hematopoietic system.
- 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.
- Patients with aggravated cardiac diseases (complex congenital heart disease, heart failure and valvular disease) or pulmonary insufficiency.
- Skin infection at the puncture site for erector spinae plane block (ESPB).
- Previous history of neurological or psychiatric diseases, with inability to read, understand and communicate.
- Current obstructive or restrictive pulmonary disease.
- Patients with BMI greater than 30 kg/m².
- Drug abuse, long-term regular use of analgesics, or allergy to the study drugs.
- Patients who refuse to provide informed consent.
- Those enrolled in other randomized controlled trials simultaneously or with other conditions unsuitable for participation in this trial.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
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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.
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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.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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AUC of resting pain score within 0-72 hours after operation
Tidsram: Postoperative 0 to 72 hours
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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.
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Postoperative 0 to 72 hours
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Postoperative adverse reaction incidence
Tidsram: Postoperative 0-72 hours
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Observe and record the incidence of postoperative adverse reactions including nausea, vomiting, dizziness and neurological complications in all patients.
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Postoperative 0-72 hours
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Time to first ambulation
Tidsram: Within 7 days after surgery
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Record the time from the end of surgery to the first off-bed ambulation of patients.
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Within 7 days after surgery
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Postoperative hospital stay
Tidsram: From the start of surgery to discharge, the average is ten days
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Record the total length of postoperative hospital stay for each patient.
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From the start of surgery to discharge, the average is ten days
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Dynamic VAS pain score at each time point
Tidsram: At 2, 6, 12, 24, 48, and 72 hours postoperatively.
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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).
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At 2, 6, 12, 24, 48, and 72 hours postoperatively.
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Dynamic VAS pain score at each time point
Tidsram: Postoperative 2 hours (h), 6h, 12h, 24h, 48h, 72 hours (h)
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Compare resting and dynamic VAS pain scores at postoperative 2h, 6h, 12h, 24h, 48h and 72h between two groups.
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Postoperative 2 hours (h), 6h, 12h, 24h, 48h, 72 hours (h)
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Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
1 februari 2027
Avslutad studie (Beräknad)
5 februari 2027
Studieregistreringsdatum
Först inskickad
24 maj 2026
Först inskickad som uppfyllde QC-kriterierna
24 juni 2026
Första postat (Faktisk)
25 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
25 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 juni 2026
Senast verifierad
1 mars 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2024-1120
Läkemedels- och apparatinformation, studiedokument
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