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.
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.
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.
Parallel
Liposomal bupivacaine plus bupivacaine hydrochloride
DrugThis 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
DrugThis 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.
AUC of resting pain score within 0-72 hours after operation
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 adverse reaction incidence
Observe and record the incidence of postoperative adverse reactions including nausea, vomiting, dizziness and neurological complications in all patients.
Time to first ambulation
Record the time from the end of surgery to the first off-bed ambulation of patients.
Postoperative hospital stay
Record the total length of postoperative hospital stay for each patient.
Dynamic VAS pain score at each time point
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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