An interventional study of Liposomal bupivacaine and ropivacaine in Liposomal Bupivacaine, Preperitoneal Infiltration and Analgesia, sponsored by Qilu Hospital of Shandong University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Qilu Hospital of Shandong University · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 146 is above the median of 78 across 1,024 interventional studies indexed under Agnosia.
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Exclusion Criteria:
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.
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, 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, liposomal bupivacaine is administered preperitoneally along the surgical incision and diluted with normal saline according to the incision length.
Prior to abdominal closure, ropivacaine is administered preperitoneally along the surgical incision and diluted with normal saline to a concentration of 0.3%.
postoperative pain score（NRS）
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.
Time frame: Day 1
Time to First Rescue Analgesia and Number of Effective Patient-Controlled Intravenous Analgesia (PCIA)
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.
Time frame: Day 3
the use of flurbiprofen axetil
the amount of rescue analgesic drugs flurbiprofen axetil used
Time frame: Day 3
postoperative adverse events
the incidence of nausea, vomiting, and vertigo after surgery
Time frame: The first 3 postoperative days
The Richards-Campbell Sleep Questionnaire
It uses a 0-100 mm visual analog scale, with higher scores indicating better sleep quality.
Time frame: day 3
Quality of Recovery-15 (QOR-15) scale
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.
Time frame: The first 3 postoperative days
Overall Benefit of Analgesia Score
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).
Time frame: The first three postoperative days
Changes in postoperative pain
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.
Time frame: The first 3 postoperative days
hospital length of stay
The time between hospital admission and discharge
Time frame: From date of hospital admission until the date of discharge,assessed up to 15 days.
C-reactive protein
The inflammatory marker of participants will be test after surgery
Time frame: On the preoperative day and postoperative day 1
White Blood Cell Count and Differential
By analyzing the WBC profile-including both total count and cell type distribution-the inflammatory condition of a patient can be evaluated.
Time frame: Day 1
Postoperative Complications
The probability of patients acquiring pulmonary complications after surgery.
Time frame: One month after surgery
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Qilu Hospital of Shandong University