Liposomal Bupivacaine Versus Ropivacaine for Preperitoneal Infiltration Analgesia in Upper Abdominal Laparotomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- postoperative pain score（NRS）
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and postoperative outcome assessors were blinded to treatment allocation. Anesthesiologists, postoperative care providers, and statisticians were also blinded. An independent study-drug preparation investigator was aware of the allocation. Because the study drugs differed in appearance, surgeons became aware of the allocation during preperitoneal infiltration at abdominal closure. The surgeons were not involved in postoperative analgesic management, outcome assessment, or data analysis.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: ropivacaine (Drug)
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.
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
postoperative pain score（NRS）
时间窗: 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.
次要结局
- C-reactive protein(On the preoperative day and postoperative day 1)
- Time to First Rescue Analgesia and Number of Effective Patient-Controlled Intravenous Analgesia (PCIA)(Day 3)
- the use of flurbiprofen axetil(Day 3)
- postoperative adverse events(The first 3 postoperative days)
- Quality of Recovery-15 (QOR-15) scale(The first 3 postoperative days)
- Postoperative Complications(One month after surgery)
- The Richards-Campbell Sleep Questionnaire(day 3)
- Overall Benefit of Analgesia Score(The first three postoperative days)
- Changes in postoperative pain(The first 3 postoperative days)
- hospital length of stay(From date of hospital admission until the date of discharge,assessed up to 15 days.)
- White Blood Cell Count and Differential(Day 1)
研究者
Jinying Zhang
Principal Investigator
Qilu Hospital of Shandong University