NCT06839716招募中不适用
Prospective Randomized Controlled Study of Ropivacaine-Poloxamer 407 Based Gel Application and TAP Block for Postoperative Pain Management Following Laparoscopic/Robotic Gastrectomy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Total fentanyl consumption within 72 hours postoperatively.
研究概览
简要总结
This study aims to determine whether Ropivacaine-Poloxamer 407 hydrogel provides non-inferior pain control compared to TAP block for patients undergoing minimally invasive gastrectomy. The results will guide postoperative pain management practices and enhance recovery protocols for gastric cancer surgery.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a histologically confirmed diagnosis of gastric adenocarcinoma prior to surgery.
- •Patients who have undergone a complete surgical resection (R0 resection).
- •Patients with an ASA (American Society of Anesthesiologists) score of 3 or below.
- •Patients aged 20 years or older.
- •Patients who have undergone laparoscopic or robotic gastrectomy
排除标准
- •Patients under 19 years of age.
- •Presence of ascites or peritoneal metastasis.
- •Patients who have undergone preoperative chemotherapy or radiotherapy.
- •Diagnosis of malignancies other than gastric cancer.
- •Uncontrolled diabetes, autoimmune diseases, hypertrophic scars, or keloid history affecting wound healing.
- •History of allergy or adverse reactions to Ropivacaine or other local anesthetics.
- •Pregnant women.
- •Patients with preoperative chronic pain conditions, including CRPS.
- •Patients with long-term preoperative use of opioid analgesics.
- •Patients with psychiatric disorders deemed likely to interfere with study participation.
- •Patients with severe liver disease, renal disease, or arrhythmia.
结局指标
主要结局
Total fentanyl consumption within 72 hours postoperatively.
时间窗: Over the first 72 hours after surgery.
The total amount of fentanyl administered to the patient via IV PCA during the initial 72-hour postoperative period will be recorded and compared among groups to assess analgesic efficacy.
次要结局
- Fentanyl usage at 12, 24, 48 hours.(Fentanyl usage at 12, 24, 48 hours.)
- NRS pain scores at 24, 48, and 72 hours (at rest and during movement).(NRS pain scores(0-10 / 0: no pain / 10: worst pain) at 24, 48, and 72 hours (at rest and during movement).)
- Pethidine usage at 24, 48, 72 hours(Pethidine usage at 24, 48, 72 hours)
- Time to first flatus and bowel movement. (up to 1 month)(1 month)
- Incidence of seroma or surgical site infection. (up to 1 month)(1 month)
- Quality of Recovery (QoR-15) scores at baseline and 72 hours(72 hours postoperatively)
- Peak Cough Flow (baseline and 72 hours)(Baseline (preoperatively) and 72 hours postoperatively)
- Length of hospital stay. (up to 1 month)(up to 1 month)
- Incidence of postoperative nausea and vomiting (PONV). (up to 72 hours)(72 hours postoperatively)
研究者
In Gyu Kwon
Assistant Professor
Gangnam Severance Hospital
研究点 (1)
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