The Effect of Liposomal Bupivacaine Erector Spinae Plane Block

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Erector Spinae Plane Block; Randomized Controlled Trial; Postoperative Analgesia; Liposome Bupivacaine
• Intervention / Treatment: Drug: Liposomal bupivacaine plus bupivacaine hydrochloride; Drug: Bupivacaine hydrochloride monotherapy

• Study Type: Interventional
• Enrollment (Estimated): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhang Liang; Phone Number: 15858281360; Email: keyanlunli_zheer@163.com

Study Locations

• China
  • Hangzhou, China
    • the Second Affiliated Hospital, Zhejiang University School of Medicine
    • Contact: Zhang; Email: keyanlunli_zheer@163.com
    • Contact: Zhang Liang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Active Comparator: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 0 to 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative adverse reaction incidence	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	Record the time from the end of surgery to the first off-bed ambulation of patients.	Within 7 days after surgery
Postoperative hospital stay	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	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	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)

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 5, 2027

Study Registration Dates

• First Submitted: May 24, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Postoperative Analgesia; Erector Spinae Plane Block; Liposome Bupivacaine
• Additional Relevant MeSH Terms: Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Bupivacaine
• Other Study ID Numbers: 2024-1120

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No