Liposomal Bupivacaine Versus Ropivacaine for Preperitoneal Infiltration Analgesia in Upper Abdominal Laparotomy

Shandong University

Status: Not yet enrolling

Conditions: Preperitoneal Infiltration; Liposomal Bupivacaine; Analgesia

Treatments: Drug: Liposomal bupivacaine; Drug: ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT07271979

KYLL-202507-101-2

Details and patient eligibility

About

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.

Full 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, and 6). 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.

Enrollment: 146 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged between 18 and 70 years.
2. Scheduled for elective upper gastrointestinal open surgery.
3. Surgical approach involving either a subcostal or midline incision.
4. Incision length between 15 and 30 cm.
5. American Society of Anesthesiologists (ASA) physical status classification of I to III.

Exclusion criteria

1. ASA Physical Status Class greater than III.

2. Pre-existing chronic pain with long-term opioid use (for >1 year).

3. 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.

4. Known allergy or hypersensitivity to the investigational drug or any of its excipients.

5. Pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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146 participants in 2 patient groups

Liposomal bupivacaine

Experimental group

Description:

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.

Treatment:

Drug: Liposomal bupivacaine

ropivacaine

Active Comparator group

Description:

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.

Treatment:

Drug: ropivacaine