The Effectiveness of Intraperitoneal Lidocaine and Bupivacaine Instillation for Reducing Postoperative Pain in Laparoscopic Abdominal Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Need for rescue opioid analgesia
研究概览
简要总结
The goal of this clinical trial is to determine the safety and efficacy of combined intraperitoneal local anesthetic instillation and port-site infiltration using lidocaine and bupivacaine in adults aged 18 to 60 undergoing elective laparoscopic abdominal surgeries (such as laparoscopic cholecystectomy, appendectomy, or hernia repair). The main questions it aims to answer are: Does combined intraperitoneal local anesthetic instillation and port-site infiltration reduce immediate and early (up to 4 hours) postoperative pain scores? Does this intervention reduce the early need for additional postoperative analgesics and shorten the length of hospital stay? Researchers will compare the treatment group receiving lidocaine (2%) and bupivacaine (0.5%) by intraperitoneal instillation and port-site infiltration with a control group receiving normal saline by the corresponding routes to determine whether the local anesthetic intervention reduces postoperative pain and analgesic requirements. Participants will undergo scheduled elective laparoscopic abdominal surgery and receive either the local anesthetic intervention or normal saline during the surgical procedure. Pain will be assessed using the Visual Analog Scale (VAS) immediately after surgery in the recovery room and again at 2 and 4 hours after surgery. Analgesic needs will be monitored and documented, and total hospital stay will be recorded.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 四盲 (受试者、医护人员、研究者、结局评估者)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Adults aged 18 to 60 years.
- Scheduled for laparoscopic abdominal surgery (e.g., laparoscopic cholecystectomy, laparoscopic appendectomy, or laparoscopic hernia repair).
- American Society of Anesthesiologists (ASA) physical status I or II.
- No history of chronic pain, opioid dependence, or severe medical comorbidities.
- Able and willing to provide written informed consent.
排除标准
- Conversion from laparoscopic to open surgery.
- Acute cholecystitis, gangrene, or empyema of the gallbladder.
- Oncologic or extensive laparoscopic procedures expected to have a prolonged operative time.
- Known allergy or hypersensitivity to lidocaine, bupivacaine, or other local anesthetic agents.
- Diabetes mellitus.
- Current systemic corticosteroid use.
- Pregnancy.
- Cardiac, pulmonary, hepatic, or renal disorders.
- History of opioid use or opioid dependence.
研究组 & 干预措施
Saline Group
Participants in this arm will receive a total of 20 mL of normal saline, divided equally between intraperitoneal instillation and port-site infiltration: 10 mL will instilled intraperitoneally over the surgical bed, while the remaining 10 mL will equally distributed among the trocar wounds.
干预措施: Placebo Normal Saline (NS) (Other)
Local Anesthetic Group
Participants in this arm will receive a total of 20 mL of study solution prepared by combining 10 mL of 2% lidocaine with 10 mL of 0.5% bupivacaine. The resulting 20-mL mixture will be divided equally between the intraperitoneal and port-site routes: 10 mL will be instilled intraperitoneally over the surgical bed, while the remaining 10 mL will be equally distributed among the trocar wounds for port-site infiltration.
干预措施: Bupivacaine (Drug)
Local Anesthetic Group
Participants in this arm will receive a total of 20 mL of study solution prepared by combining 10 mL of 2% lidocaine with 10 mL of 0.5% bupivacaine. The resulting 20-mL mixture will be divided equally between the intraperitoneal and port-site routes: 10 mL will be instilled intraperitoneally over the surgical bed, while the remaining 10 mL will be equally distributed among the trocar wounds for port-site infiltration.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Need for rescue opioid analgesia
时间窗: Immediately after surgery, 2 hours after surgery, and 4 hours after surgery
Number of participants requiring rescue opioid analgesia for postoperative pain.
次要结局
- Postoperative pain intensity(Immediately after surgery, 2 hours after surgery, and 4 hours after surgery)
- Length of hospital stay(From admission until hospital discharge (up to 1 week))
- Surgery duration(During surgery)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07775599
- 其他研究编号
- 2025/0099
日期
- 首次提交
- (上个月)
- 首次发布
- (上个月)
- 主要完成日期
- (2个月前)
- 研究完成日期
- (2个月前)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否