The Effect of Liposomal Bupivacaine Erector Spinae Plane Block

NCT07667439 | Not Yet Recruiting

• 1 other identifier: 2024-1120
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liposome Bupivacaine; Erector Spinae Plane Block; Postoperative Analgesia; Randomized Controlled Trial

Keywords

Liposome Bupivacaine; Erector Spinae Plane Block; Postoperative Analgesia; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postoperative adverse reaction incidence

  Postoperative 0-72 hours

• Time to first ambulation

  Within 7 days after surgery

• Postoperative hospital stay

  From the start of surgery to discharge, the average is ten days

• Dynamic VAS pain score at each time point

  At 2, 6, 12, 24, 48, and 72 hours postoperatively.

• Dynamic VAS pain score at each time point

  Postoperative 2 hours (h), 6h, 12h, 24h, 48h, 72 hours (h)

Study Arms (2)

Liposomal Bupivacaine Combined Intervention Arm

EXPERIMENTAL

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

Conventional Bupivacaine Single Agent Arm

ACTIVE COMPARATOR

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

Interventions

Liposomal bupivacaine plus bupivacaine hydrochloride DRUG

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.

Liposomal Bupivacaine Combined Intervention Arm

Bupivacaine hydrochloride monotherapy DRUG

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.

Conventional Bupivacaine Single Agent Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

the Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Zhang Liang

CONTACT

15858281360; keyanlunli_zheer@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 5, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-03

Locations

CN (1)