The Effect of Liposomal Bupivacaine Erector Spinae Plane Block

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Liposomal bupivacaine plus bupivacaine hydrochloride
  • Bupivacaine hydrochloride monotherapy

Treatment groups

148 Participants
are divided into 2 treatment groups