Effect of Ultrasound-guided External Oblique Intercostal Fascial Plane Block in Pediatric Patients Undergoing Laparoscopic Gastrostomy: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percent change in heart rate at surgical incision
研究概览
简要总结
This randomized controlled trial will evaluate the efficacy of ultrasound-guided external oblique intercostal fascial plane (EOI) block in reducing intraoperative and postoperative pain in pediatric patients undergoing laparoscopic gastrostomy under general anesthesia. Forty patients aged 3-18 years will be randomly allocated to receive either bilateral EOI block with 0.25% ropivacaine or sham block with normal saline. Primary outcome is percent change in heart rate at surgical incision. Secondary outcomes include intraoperative fentanyl use, perioperative analgesic requirements, postoperative pain scores (r-Face, Legs, Activity, Cry, Consolability(r-FLACC) and Pediatric Pain Profile), Analgesia Nociception Index values, and analgesia-related adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for laparoscopic gastrostomy at Seoul National University Children's Hospital
- •Age ≥3 and <18 years
排除标准
- •Unstable vital signs
- •Contraindications to ropivacaine or opioids
- •Severe hepatic or renal dysfunction
- •Other investigator-determined ineligibility
研究组 & 干预措施
EOI block group
干预措施: EOI block (Procedure)
control group
干预措施: sham block (Procedure)
结局指标
主要结局
Percent change in heart rate at surgical incision
时间窗: At surgical incision (baseline immediately before incision and within 10 minutes after incision).
Post-incision HR - Pre-incision HR) / Pre-incision HR × 100
次要结局
- Intraoperative fentanyl use(From induction of anesthesia to end of surgery.)
- Percent change in mean arterial pressure at incision(At surgical incision (baseline immediately before incision and within 10 minutes after incision).)
- Intraoperative max-min heart rate(Intraoperative period (skin incision to end of surgery).)
- Intraoperative max-min mean arterial pressure(Intraoperative period (skin incision to end of surgery).)
- ANI time-weighted average outside target (50-80)(From induction of anesthesia to end of anesthesia (arrival to PACU).)
- Pediatric Pain Profile score(24 hours after surgery.)
- r-Face, Legs, Activity, Cry, Consolability pain scores(At PACU 15 minutes and 30 minutes; and at 1, 3, 6, and 24 hours after surgery.)
- analgesia nociception index (ANIm) values in PACU(At 15 and 30 minutes after PACU arrival.)
- Non-opioid analgesic consumption (mg/kg)(From end of surgery to 24 hours postoperatively.)
- Analgesic-related adverse effects(Up to 24 hours after surgery.)
- Opioid analgesic consumption (mcg/kg)(From end of surgery to 24 hours postoperatively.)
研究者
Jin-Tae Kim
professor
Seoul National University Hospital