Erector Spinae Plane Block, Liposome Bupivacaine, Postoperative Analgesia, Randomized Controlled Trial
Conditions
Keywords
Liposome Bupivacaine, Erector Spinae Plane Block, Postoperative Analgesia, Randomized Controlled Trial
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.
Interventions
DRUGLiposomal 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.
DRUGBupivacaine 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.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC of resting pain score within 0-72 hours after operation | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative adverse reaction incidence | Postoperative 0-72 hours | Observe and record the incidence of postoperative adverse reactions including nausea, vomiting, dizziness and neurological complications in all patients. |
| Time to first ambulation | Within 7 days after surgery | Record the time from the end of surgery to the first off-bed ambulation of patients. |
| Postoperative hospital stay | From the start of surgery to discharge, the average is ten days | Record the total length of postoperative hospital stay for each patient. |
| Dynamic VAS pain score at each time point | 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). |
Countries
China
Contacts
CONTACTZhang Liang
Outcome results
None listed