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NCT Number: NCT07667439

The Effect of Liposomal Bupivacaine Erector Spinae Plane Block

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.

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Key information

Conditions

Liposome Bupivacaine Erector Spinae Plane Block Postoperative Analgesia Randomized Controlled Trial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Location contact

Zhang

CONTACT

[email protected]

Zhang Liang

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. AUC of resting pain score within 0-72 hours after operation

    Time frame: 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.

Secondary outcomes

  1. Postoperative adverse reaction incidence

    Time frame: Postoperative 0-72 hours

    Observe and record the incidence of postoperative adverse reactions including nausea, vomiting, dizziness and neurological complications in all patients.

  2. Time to first ambulation

    Time frame: Within 7 days after surgery

    Record the time from the end of surgery to the first off-bed ambulation of patients.

  3. Postoperative hospital stay

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

    Record the total length of postoperative hospital stay for each patient.

  4. Dynamic VAS pain score at each time point

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

    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).

  5. Dynamic VAS pain score at each time point

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

    Compare resting and dynamic VAS pain scores at postoperative 2h, 6h, 12h, 24h, 48h and 72h between two groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhang Liang

CONTACT

[email protected]

15858281360

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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