Ultrasound-guided Selective Supraclavicular Nerve Block for Postoperative Pain Control in Pediatric Patients Receiving Hickman Catheter, Chemoport or Perm Cath Insertion : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
This prospective randomized controlled trial aims to investigate the effect of ultrasound-guided selective supraclavicular nerve block on pain control after Hickman catheter, chemoport, or Perm cath insertion in children.
详细描述
Pediatric patients undergoing surgical insertion of a Hickman catheter, chemoport, or Permcath are randomly assigned to a test group (Ultrasound-guided selective supraclavicular nerve block with Ropivacaine) and a control group (Nerve block is not performed).
Immediately after induction of general anesthesia, in the test group, the supraclavicular nerve block was selectively performed using ultrasound using 0.1mL/kg of 0.5% Ropivacaine (Maximum dose: 5mL), and the nerve block was not completed in the control group. After that, a Hickman catheter, chemoport, or Permcath is surgically inserted in the usual way and allowed to recover from anesthesia.
The pain score is evaluated between 10 and 30 minutes of entering the recovery room (1 hour after the procedure) and 1 hour, 3 hours, and 24 hours after leaving the recovery room by another research team who is unaware of the group assignment. In addition, the use of additional analgesic drugs and related side effects were collected before discharge.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients receiving Hickman catheter, chemoport, or Perm cath implantation (3 years ≤, <18 years)
- •One or more of the parents (or guardians), after hearing and understanding a sufficient explanation about this clinical trial, decides to participate voluntarily and agrees in writing to abide by the precautions
- •In the case of a study subject aged seven years or older, a person who voluntarily decides to participate in this clinical trial and agrees in writing to abide by the precautions after hearing and understanding a sufficient explanation about this clinical trial
排除标准
- •Patients who undergo surgery other than the surgery.
- •Patients with diseases whose sensitivity to pain is different from that of the general public
- •Unstable vital signs (heart rate, blood pressure)
- •General contraindications of Ropivacaine
- •Patients with a history of allergy to opioids
- •Severe renal dysfunction (Creatinine> 3.0 mg/dl)
- •Severe liver dysfunction (aspartate transaminase > 120 unit/L, alanine aminotransferase > 120 unit/L)
- •Peripheral nervous system abnormalities
- •At risk of malignant hyperthermia
- •Other cases that the researcher judges to be inappropriate
研究组 & 干预措施
Selective supraclavicular nerve block
After induction of anesthesia, the anesthesiologist sterilizes the skin of the area to be punctured. In the test group, an Ultrasound-guided selective supraclavicular nerve block is performed using 0.5% Ropivacaine 0.1mL/kg (Maximum dose: 5mL).
干预措施: Ropivacaine (Drug)
Control
The nerve block is not performed in the control group.
干预措施: Control (without intervention) (Other)
结局指标
主要结局
Pain score
时间窗: Pain score measured when communication is possible between 10 and 30 minutes after entering the recovery room.
Numeric rating scale is also evaluated if communication is possible
次要结局
- Hospital stay(No more than one month)
- Pain score(Pain score for 1 hour, 3 hours, and 24 hours after leaving the recovery room)
- Whether diaphragmatic palsy(Within 24 hours of the end of surgery)
- Additional narcotic analgesics administered(Within 24 hours of the end of surgery)
- Additionally administered non-narcotic analgesics(Within 24 hours of the end of surgery)
- Side effects related to pain medication(Within 24 hours of the end of surgery)
- Complications related to ropivacaine use(Within 1 hour after procedure)
- Check the blockage(When communication is possible between 10 and 30 minutes after entering the recovery room.)
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital