About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
ASA Physical Status Class greater than III.
Pre-existing chronic pain with long-term opioid use (for >1 year).
Known allergy or hypersensitivity to the investigational drug or any of its excipients.
Pregnancy or lactation
Trial design
Parallel
Treatments tested in this trial
Liposomal bupivacaine
DrugPrior to abdominal closure, liposomal bupivacaine is administered preperitoneally along the surgical incision and diluted with normal saline according to the incision length.
ropivacaine
DrugPrior to abdominal closure, ropivacaine is administered preperitoneally along the surgical incision and diluted with normal saline to a concentration of 0.3%.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
the use of flurbiprofen axetil
the amount of rescue analgesic drugs flurbiprofen axetil used
postoperative adverse events
the incidence of nausea, vomiting, and vertigo after surgery
The Richards-Campbell Sleep Questionnaire
It uses a 0-100 mm visual analog scale, with higher scores indicating better sleep quality.
Sponsors and contacts
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