Effects of Ultrasound-guided External Oblique Intercostal Block Versus Transversus Abdominis Plane Combined With Rectus Sheath Block on Postoperative Pain in Laparoscopic Radical Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cumulative opioid consumption within 24 hours postoperatively
研究概览
简要总结
Postoperative pain is highly prevalent following laparoscopic radical gastrectomy. Although Transversus abdominis plane block combined with rectus sheath block(TAP+RSB） can effectively alleviate this pain, it still has many limitations. The external oblique intercostal plane block (EOIB) is a novel nerve block technique that may provide well postoperative analgesia for upper abdominal surgery. Therefore, this study employs a non-inferiority randomized controlled trial design to verify that the analgesic effect of EOIB is not inferior to that of ESPB, thereby offering more options for regional analgesia strategies in laparoscopic radical gastrectomy.
详细描述
Laparoscopic radical gastrectomy (including subtotal and total gastrectomy) is the most commonly used surgical approach for gastric cancer. Although this technique is less invasive than traditional open surgery, more than 50% of patients still experience moderate to severe acute pain in the early postoperative period, making effective postoperative pain management essential. Regional nerve blockade techniques have become a key component of postoperative analgesia due to their reliable analgesic effect and significant reduction in opioid consumption.
The transversus abdominis plane block combined with rectus sheath block(TAP+RSB) is considered a relatively safe nerve block for upper abdominal surgery analgesia. However, the spread of the local anesthetic and the resulting block effect are unpredictable.
The external oblique intercostal plane block (EOIB) is a recently proposed regional block technique for the upper abdomen. This block involves injecting local anesthetic into the superficial fascial plane between the external oblique muscle and the intercostal muscles, thereby blocking the anterior rami and cutaneous branches of the intercostal nerves from T6-T10, which can provide effective analgesia for upper abdominal incision areas.
Nevertheless, current research on the analgesic effect of EOIB after laparoscopic radical gastrectomy remains limited, particularly lacking high-quality, prospective, randomized controlled studies to verify whether EOIB can achieve analgesic effects comparable to those of TAP+RSB， Therefore, this study adopts a non-inferiority randomized controlled trial design to verify that the postoperative analgesic effect of EOIB is better than TAP+RSB, providing more options for regional analgesia strategies in laparoscopic radical gastrectomy.
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, Investigator)
盲法说明
On the day of surgery, after the induction of general anesthesia, the study coordinator opened the corresponding envelope in the order of recruitment. Patients were randomly assigned to receive either EOIB or TAP+RSB, which was performed preoperatively by an experienced anesthesiologist. The anesthesiologist was aware of the intervention, but all patients, data investigator and postoperative follow-up remained blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged over 18 years
- •Classified as ASA I-III
- •Scheduled for elective laparoscopic radical gastrectomy under general anesthesia
- •Voluntarily participated and provided written informed consent.
排除标准
- •Chronic opioid dependence or prior use of analgesic medications for >3 months;
- •Inability to communicate due to severe dementia, language barriers, or terminal illness;
- •History of central and/or peripheral nervous system disorders;
- •Severe renal insufficiency (serum creatinine >442 μmol/L or requiring renal replacement therapy) or severe hepatic insufficiency (Child-Pugh class C);
- •Allergy to local anesthetics.
- •Expected to be transferred to ICU after surgery.
- •Refuse patient control agenesia after surgery.
结局指标
主要结局
Cumulative opioid consumption within 24 hours postoperatively
时间窗: 24 hours after surgery
Cumulative opioid consumption within 24 hours postoperatively. Conversion to morphine equivalent dose (mg)
次要结局
- Pain Intensity(2, 6, 12, 24, 48, and 72 hours postoperatively)
- Quality of Recovery(24,48,72 hours after surgery)
- sleep quality(24,48,72 hours after surgery)