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

February 24, 2026 updated by: Jinying Zhang, Qilu Hospital of Shandong University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Jinan, China
        • Recruiting
        • Qilu Hospital of Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the use of flurbiprofen axetil
Time Frame: Day 3
the amount of rescue analgesic drugs flurbiprofen axetil used
Day 3
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
From date of hospital admission until the date of discharge,assessed up to 15 days.
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.
Day 3
postoperative adverse events
Time Frame: The first 3 postoperative days
the incidence of nausea, vomiting, and vertigo after surgery
The first 3 postoperative days
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.
day 3
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.
The first 3 postoperative days
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).
The first three postoperative days
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.
The first 3 postoperative days
C-reactive protein
Time Frame: On the preoperative day and postoperative day 1
The inflammatory marker of participants will be test after surgery
On the preoperative day and postoperative day 1
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.
Day 1
Postoperative Complications
Time Frame: One month after surgery
The probability of patients acquiring pulmonary complications after surgery.
One month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 15, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Actual)

December 9, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-202507-101-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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