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Liposomal Bupivacaine Versus Ropivacaine for Preperitoneal Infiltration Analgesia in Upper Abdominal Laparotomy: A Randomized Double-Blind Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Qilu Hospital of Shandong University
RECRUITING
Jinan
Contact Information
Primary
Jinying Zhang
zhjydzx@163.com
18560087707
Time Frame
Start Date: 2026-01-04
Estimated Completion Date: 2026-06
Participants
Target number of participants: 146
Treatments
Experimental: Liposomal bupivacaine
Prior to abdominal closure, the subject received a preperitoneal administration of liposomal bupivacaine at the surgical incision site. The total injection dose did not exceed 266 mg. A volume of 1 ml of the drug solution was administered per 1.5 cm of wound length per side.
Active_comparator: ropivacaine
Prior to abdominal closure, the subject received a preperitoneal administration of 0.3% ropivacaine at the surgical incision site. A volume of 1 ml of the drug solution was administered per 1.5 cm of wound length per side.
Related Therapeutic Areas
Sponsors
Leads: Qilu Hospital of Shandong University

This content was sourced from clinicaltrials.gov

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