Liposomal Bupivacaine Versus Ropivacaine for Preperitoneal Infiltration Analgesia in Upper Abdominal Laparotomy
Liposomal Bupivacaine Versus Ropivacaine for Preperitoneal Infiltration Analgesia in Upper Abdominal Laparotomy: A Randomized Double-Blind Controlled Trial
Qilu Hospital of Shandong University
146 participants
Jan 4, 2026
INTERVENTIONAL
Conditions
Summary
Upper abdominal open surgery is associated with significant trauma, and postoperative pain management poses considerable challenges. The inflammatory response triggered by peritoneal incision and the transmission of visceral pain via the vagus nerve are key components of "surgical stress" and pain. A potential intervention strategy involves the local administration of anesthetic agents to suppress peritoneal overreaction and block the cascade of pro-inflammatory cytokines in related nerves. Liposomal bupivacaine, as a long-acting local anesthetic, may provide more prolonged postoperative analgesia compared to ropivacaine. Therefore, this trial aims to prospectively compare the analgesic efficacy and anti-inflammatory effects of the two drugs when administered as pre-closure preperitoneal infiltration. Secondary endpoints include opioid consumption, complication rates, and postoperative recovery indicators, to comprehensively evaluate their clinical value.
Eligibility
Inclusion Criteria5
- Aged 18 to 75 years; for those \>70 years old, a Karnofsky Performance Status (KPS) score ≥80 is required.
- Scheduled for elective upper abdominal laparotomy.
- Surgical approach involving either a subcostal or midline incision.
- Incision length between 15 and 30 cm.
- American Society of Anesthesiologists (ASA) physical status classification of I to III.
Exclusion Criteria6
- ASA Physical Status Class greater than III.
- Pre-existing chronic pain with long-term opioid use (for \>1 year).
- Significant hepatic or renal impairment, or underweight status, defined as:
- Estimated glomerular filtration rate (eGFR) of \<40 mL/min/1.73m²; Child-Pugh Class C; Body Mass Index (BMI) \<18.5 kg/m².
- Known allergy or hypersensitivity to the investigational drug or any of its excipients.
- Pregnancy or lactation
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Interventions
Prior to abdominal closure, liposomal bupivacaine is administered preperitoneally along the surgical incision and diluted with normal saline according to the incision length.
Prior to abdominal closure, ropivacaine is administered preperitoneally along the surgical incision and diluted with normal saline to a concentration of 0.3%.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07271979