Liposome BupivacaineNCT07667439
The Effect of Liposomal Bupivacaine Erector Spinae Plane Block
A study testing Liposomal bupivacaine plus bupivacaine hydrochloride and Bupivacaine hydrochloride monotherapy in people with Liposome Bupivacaine and Erector Spinae Plane Block, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liposome Bupivacaine, Erector Spinae Plane Block, Postoperative Analgesia
- What is being tested?
- Liposomal bupivacaine plus bupivacaine hydrochloride and Bupivacaine hydrochloride monotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 5 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Zhang, keyanlunli_zheer@163.com
Zhang Liang
About this study
Official 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
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
- Being tested
- Liposomal bupivacaine plus bupivacaine hydrochloride, Bupivacaine hydrochloride monotherapy
- Keywords
- Liposome Bupivacaine, Erector Spinae Plane Block, Postoperative Analgesia, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaine plus bupivacaine hydrochlorideDrug
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 monotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Bupivacaine hydrochloride monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative 0 to 72 hours
Secondary outcomes (5)
Postoperative adverse reaction incidence
Observe and record the incidence of postoperative adverse reactions including nausea, vomiting, dizziness and neurological complications in all patients.
Measured: Postoperative 0-72 hours
Time to first ambulation
Record the time from the end of surgery to the first off-bed ambulation of patients.
Measured: Within 7 days after surgery
Postoperative hospital stay
Record the total length of postoperative hospital stay for each patient.
Measured: 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).
Measured: 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.
Measured: Postoperative 2 hours (h), 6h, 12h, 24h, 48h, 72 hours (h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion5 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liposome BupivacaineStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667439
- Sponsor's protocol ID
- 2024-1120
- Status last verified
- Mar 2026
- First submitted
- 24 May 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07667439
- Acronym / sponsor ID
- 2024-1120
- Conditions
- Liposome Bupivacaine, Erector Spinae Plane Block, Postoperative Analgesia, Randomized Controlled Trial
- Keywords
- Liposome Bupivacaine, Erector Spinae Plane Block, Postoperative Analgesia, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 5 Feb 2027 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine Combined Intervention Arm | Experimental | Drug: Liposomal bupivacaine plus bupivacaine hydrochloridePatients 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. |
| Conventional Bupivacaine Single Agent Arm | Active comparator | Drug: Bupivacaine hydrochloride monotherapyPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal bupivacaine plus bupivacaine hydrochlorideThis 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. | Drug | Liposomal Bupivacaine Combined Intervention Arm |
| Bupivacaine hydrochloride monotherapyThis 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. | Drug | Conventional Bupivacaine Single Agent Arm |
Primary outcome
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.
5 secondary outcomes
Postoperative adverse reaction incidence
Time frame: Postoperative 0-72 hours
Time to first ambulation
Time frame: Within 7 days after surgery
Postoperative hospital stay
Time frame: From the start of surgery to discharge, the average is ten days
Dynamic VAS pain score at each time point
Time frame: At 2, 6, 12, 24, 48, and 72 hours postoperatively.
Dynamic VAS pain score at each time point
Time frame: Postoperative 2 hours (h), 6h, 12h, 24h, 48h, 72 hours (h)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposomal bupivacaine plus bupivacaine hydrochloride and Bupivacaine hydrochloride monotherapy in people with Liposome Bupivacaine and Erector Spinae Plane Block, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhang Liang (15858281360, keyanlunli_zheer@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of resting pain score within 0-72 hours after operation (time frame: Postoperative 0 to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.