Prospective Randomized Controlled Trial of Ropivacaine-Poloxamer 407 Based Gel Application on Postoperative Pain After Open Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Total fentanyl consumption within 72 hours postoperatively.
研究概览
简要总结
The study evaluates the efficacy of Ropivacaine-Poloxamer 407 hydrogel in reducing postoperative pain following open 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, Outcomes Assessor)
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.
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.
研究组 & 干预措施
Placebo group
Patients who did not apply Ropivacaine-Poloxamer 407 hydrogel
干预措施: Arm II (Subcutaneous injection group) (Procedure)
Peritoneal application group
Patients who applied Ropivacaine-Poloxamer 407 hydrogel on space between peritoneum and fascia
干预措施: Arm I (Peritoneal application group) (Procedure)
Subcutaneous injection group
Patients who injected Ropivacaine-Poloxamer 407 hydrogel on subcutaneous area
干预措施: Arm II (Subcutaneous injection group) (Procedure)
Placebo group
Patients who did not apply Ropivacaine-Poloxamer 407 hydrogel
干预措施: Arm I (Peritoneal application group) (Procedure)
结局指标
主要结局
Total fentanyl consumption within 72 hours postoperatively.
时间窗: Total fentanyl consumption within 72 hours postoperatively.
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
- Pain intensity scores (NRS) at rest and during movement.(Pain intensity: Measured at 24, 48, and 72 hours postoperatively.)
- Time to first flatus and bowel movement.(Bowel function: Time to first flatus and bowel movement recorded until discahrge (within 6 days))
- Occurrence of postoperative nausea and vomiting (PONV).(PONV: Assessed daily for 72 hours.)
- Wound healing assessment, including seroma and infection rates.(Wound healing: Evaluated at regular intervals until first outpatient day (within 14 days))
- Length of hospital stay.(Hospital stay: up to 1 month)
- Quality of recovery (QoR-15).(QoR-15: Measured at baseline and 72 hours postoperatively.)
研究者
In Gyu Kwon
Assistant Professor
Gangnam Severance Hospital