NCT07271979

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients undergoing upper gastrointestinal open surgery often experience moderate to severe postoperative pain, which not only hinders early recovery but also significantly impairs their quality of life. Ideal postoperative analgesia requires a balance between efficacy and safety, and preperitoneal local anesthetic administration serves as an effective strategy to achieve this goal. Compared to conventional local anesthetics, liposomal bupivacaine-as a novel sustained-release formulation-enables continuous drug release, extending the analgesic duration to 48-72 hours. This study aims to compare the postoperative analgesic effects of preperitoneal injection of liposomal bupivacaine versus ropivacaine in patients undergoing upper gastrointestinal open surgery. This study employs a randomized controlled design. Participants will be stratified based on the type of surgical incision (midline or subcostal) and randomized into groups using a computer-generated random seed with permuted block randomization (variable block sizes of 2, 4). Prior to abdominal closure during surgery, the experimental group will receive liposomal bupivacaine injections into the preperitoneal space on both sides of the wound, while the control group will receive ropivacaine injections. Apart from this intervention, both groups will maintain identical protocols for anesthesia induction, maintenance, and postoperative systemic analgesia to accurately evaluate the relative efficacy of the two local analgesic agents.

Conditions

• Liposomal Bupivacaine
• Preperitoneal Infiltration
• Analgesia

Interventions

Type	Name	Description
DRUG	Liposomal bupivacaine	Prior to abdominal closure, liposomal bupivacaine is administered preperitoneally along the surgical incision and diluted with normal saline according to the incision length.
DRUG	ropivacaine	Prior to abdominal closure, ropivacaine is administered preperitoneally along the surgical incision and diluted with normal saline to a concentration of 0.3%.

Timeline

• Start date: 2026-01-04
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2025-12-09
• Last updated: 2026-02-27

Locations

1 site across 1 country: China