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NCT Number: NCT07271979

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

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.

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Key information

Conditions

Liposomal Bupivacaine Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Preperitoneal Infiltration Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qilu Hospital of Shandong University

Jinan, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Liposomal bupivacaine

Drug

Prior to abdominal closure, liposomal bupivacaine is administered preperitoneally along the surgical incision and diluted with normal saline according to the incision length.

Ropivacaine

Drug

Prior to abdominal closure, ropivacaine is administered preperitoneally along the surgical incision and diluted with normal saline to a concentration of 0.3%.

Primary outcomes

  1. postoperative pain score（NRS）

    Time frame: Day 1

    The Numeric Rating Scale (NRS) is an 11-point scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents the "worst pain imaginable." Based on this, scores of 1-3 indicate mild pain, 4-6 indicate moderate pain requiring intervention, and 7-10 indicate severe pain necessitating urgent treatment. In this study, the investigators primarily assessed the incidence of an NRS score ≥ 4 within 24 hours postoperatively and the worst pain experienced by patients during that period.

Secondary outcomes

  1. Time to First Rescue Analgesia and Number of Effective Patient-Controlled Intravenous Analgesia (PCIA)

    Time frame: Day 3

    The PCIA protocol (sufentanil 2 μg/kg in 100 mL saline, no background infusion, 3 mL bolus, 30-min lockout) was used. We recorded the time to first PCIA activation and the cumulative number of effective boluses within the first 72 postoperative hours.

  2. the use of flurbiprofen axetil

    Time frame: Day 3

    the amount of rescue analgesic drugs flurbiprofen axetil used

  3. postoperative adverse events

    Time frame: The first 3 postoperative days

    the incidence of nausea, vomiting, and vertigo after surgery

  4. The Richards-Campbell Sleep Questionnaire

    Time frame: day 3

    It uses a 0-100 mm visual analog scale, with higher scores indicating better sleep quality.

  5. Quality of Recovery-15 (QOR-15) scale

    Time frame: The first 3 postoperative days

    The scores from all 15 questions are summed to yield a total score ranging from 0 to 150, with a higher total score indicating a better quality of recovery for the patient.

  6. Overall Benefit of Analgesia Score

    Time frame: The first three postoperative days

    This score is a patient-reported outcome measure for comprehensively evaluating the effectiveness of postoperative analgesic regimens, using a 29-point scale from 0 (best) to 28 (worst).

  7. Changes in postoperative pain

    Time frame: The first 3 postoperative days

    Changes in pain scores (NRS) within the first 3 days postoperatively, including scores at rest at 6, 12, 24, 48, and 72 hours, as well as the peak pain level during this 3-day period.

  8. hospital length of stay

    Time frame: From date of hospital admission until the date of discharge,assessed up to 15 days.

    The time between hospital admission and discharge

  9. C-reactive protein

    Time frame: On the preoperative day and postoperative day 1

    The inflammatory marker of participants will be test after surgery

  10. White Blood Cell Count and Differential

    Time frame: Day 1

    By analyzing the WBC profile-including both total count and cell type distribution-the inflammatory condition of a patient can be evaluated.

  11. Postoperative Complications

    Time frame: One month after surgery

    The probability of patients acquiring pulmonary complications after surgery.

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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