Liposomal bupivacaine versus ropivacaine for preperitoneal pain relief after upper abdominal open surgery

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

This compares liposomal bupivacaine with ropivacaine to see if injecting the long-acting drug into the preperitoneal space gives longer pain relief for adults having elective upper abdominal open surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 146 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (Academic / other)
• Locations: 1 site (Jinan)
• Trial ID: NCT07271979 on ClinicalTrials.gov

What this trial studies

This is a randomized, controlled trial enrolling adults undergoing elective upper gastrointestinal open surgery with a midline or subcostal incision. Participants are stratified by incision type and randomized to receive either liposomal bupivacaine or ropivacaine injected into the preperitoneal space before abdominal closure, with all other anesthetic and postoperative analgesic care standardized. The primary focus is postoperative analgesic duration and anti-inflammatory effects at the wound site, with secondary endpoints including opioid consumption, complication rates, and recovery indicators. Outcomes will be compared between groups to determine relative clinical value of the two local anesthetics.

Who should consider this trial

Good fit: Adults aged 18–75 scheduled for elective upper abdominal laparotomy with a 15–30 cm midline or subcostal incision and ASA physical status I–III are ideal candidates.

Not a fit: Patients with ASA status >III, significant renal or hepatic impairment, long-term opioid use, pregnancy or known allergy to study drugs are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, patients could experience longer-lasting postoperative pain relief and reduced opioid needs in the first 48–72 hours after upper abdominal open surgery.

How similar studies have performed: Previous trials of liposomal bupivacaine for surgical wound infiltration have shown mixed results across procedures—some report longer analgesia while others show little advantage—making this specific preperitoneal application relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Aged 18 to 75 years; for those \>70 years old, a Karnofsky Performance Status (KPS) score ≥80 is required.
2. Scheduled for elective upper abdominal laparotomy.
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

Where this trial is running

Jinan

• Qilu Hospital of Shandong University — Jinan, China (Recruiting)

Study contacts

• Study coordinator: Jinying Zhang

Conditions Liposomal Bupivacaine; Preperitoneal Infiltration; Analgesia