Liposomal bupivacaine plus bupivacaine hydrochlorideBupivacaine hydrochloride monotherapy
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.
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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
AUC of resting pain score within 0-72 hours after operation — 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.
Trial sites (1)
Facility
City
Region
Status
the Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
China
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.