TAP Block Versus Local Anesthesia Infiltration at Wound Site for Postoperative Pain Relief After Laparoscopic Appendicectomy in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- cumulative dose of nalbuphine in the 24 first hours post surgery
研究概览
简要总结
When performing laparoscopic appendectomy in children, regional anesthetic techniques are rou-tinely used concomitantly with general anesthesia. These techniques include local infiltration of the trocar wounds or transverse abdominal plane block (TAP block). In 2018, a position paper of the European Society of Pediatric Anaesthesiology advised for TAP block over local infiltration of the trocar wounds. However, there is no randomized study comparing both techniques in children. The aim of this study is to compare morphine consumption during the first 24 postoperative hours in children undergoing laparoscopic appendectomy and randomly allocated to either local infiltration of the trocar wounds or TAP block.
详细描述
This is a double blind randomized study with two parallel groups. Children between 3 and 15 years of age with indication of laparoscopic appendectomy will be approached for inclusion in this trial. Informed consent will be asked for from the parents and the child. Before surgery, patients will be randomized to either local infiltration of the trocar wounds or TAP block using sequentially numbered sealed envelope each with a random number inside. Patients with peritonitis will be excluded. A standardized analgesia protocol within the first 24 post-operative hours will be applied and the primary outcome is nalbuphine consumption during this time frame. Secondary outcomes include postoperative pain (FLACC assessment tool) and postoperative nausea and vomiting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age betwween 3 and 15 years
- •Weight < or = 50 kg
- •indicaction of coelioscopic appendicectomy
- •ASA 1,2 or 3
- •consent of the children and the holder of parental autority
排除标准
- •Age<3 years or > 15years or weight > 50kg
- •refusal of the children and the holder of parental autority
- •Peritonitis
- •Patients with long term morphinic traitment
- •Hepato-cellular insuffisiancy
- •local anesthesia allergy or nalbuphine allergy
- •coagulation abnomrmality
- •exclusion of health insurance
研究组 & 干预措施
TAP Block
Transverse abdominal block is realisated at the beginning of the surgery with ultrasound guided technique with levobupivacaine 2.5mg/mL, 0.3mL/kg each side.
The patient receives usual analgesia protocol.
干预措施: Levobupivacaine Hydrochloride 2.5 MG/ML (Drug)
local infiltration of the trocar wounds
local infiltration of the trocar wounds is realisated at the end of the surgery by the surgeon with levobupivacaine 2.5mg/mL 0.6mL/kg distributed in each trocar opening.
The patient receives usual analgesia protocol.
干预措施: Levobupivacaine Hydrochloride 2.5 MG/ML (Drug)
结局指标
主要结局
cumulative dose of nalbuphine in the 24 first hours post surgery
时间窗: 24 hours
recording in mg/kg
次要结局
- adverse events(in the first 24 post operative hours)
- timing of first standing up(in the first 24 post operative hours)
- cumulative dose of nalbuphine H0-H12 post surgery(from beginning to 12th hour)
- FLACC analgesia score at H1 H2 H6 H12 H24(FLACC score will be performed from awakenig to 24 hours post surgery)
- FLACC score mean(FLACC score will be performed from awakenig to 24 hours surgery)
- cumulative dose of nalbuphine H13-H24 post surgery(From 13th hour to 24th hour)
- individual variations of FLACC score(FLACC score will be performed from awakenig to 24 hours surgery)
- timing of first injection of nalbuphine(in the first 24 post operative hours)
- incidence of post operative nausea and vomiting(in the first 24 post operative hours)