Volume or Concentration for the Transverse Abdominal Plane Block in Children Aged 1-5 Years: Analgesic Effects and Safety
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- number of patients for whom a rescue analgesia was necessary in post anesthesia care unit and ambulatory surgery unit
研究概览
简要总结
The transversus abdominis plane (TAP) block provide a local anesthesia drug diffusion between the transverse abdominis muscle and the internal oblique muscle. TAP block reaches the anterior rami of spinal nerves from T7 to L1 involved in the innervation of homolateral abdominal wall. The transversus abdominis plane block has shown promise for perioperative analgesia, but data on the optimal dose regimen are limited.Following previous research of optimal dose of local anesthesic solution, the investigators aim to evaluate if a "volume effect" would lead to a better diffusion of the local anesthesic solution to the overall nervous roots. The local anesthesia drug choosen is levobupivacaine with a unique posology of 0,4 mg/kg (either 0,2 ml/kg of 0,2% levobupivacaine for "small volume" group or 0,4 ml/kg of 0,1% levobupivacaine for "high volume" group).With the same dose of levobupivacaine, this study aims to assess the impact of volume effect on analgesia efficiency as well as the security as after ultrasound TAP block on one to five years' old children who undergo a peritoneal-vaginal duct surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalisation in ambulatory surgery and anesthesia unit for surgery of inguinal hernia or ovarian hernia or hydrocele or cord kyst
- •Overall status: ASA I-II
- •Aged from 1 to 5 years
- •Informed consent
排除标准
- •Coagulation trouble
- •Infection on ponction zone
- •Local anesthesia drug or nonsteroidal anti inflammatory intolerance
- •Cardiac/Renal/hepacticdysfunction
- •Hemorrage, digestive perforation history
研究组 & 干预措施
Small volume
Local analgesia by one injection of 0,2 ml/kg of 0,2% lévobupivacaine
干预措施: Injection of 0,2 ml/kg of 0,2% levobupivacaine for small volume group (Drug)
High volume
Local analgesia by one injection of 0,4 ml/kg of 0,1% lévobupivacaine
干预措施: Injection of 0,4 ml/kg of 0,1% lévobupivacaine for high volume group (Drug)
结局指标
主要结局
number of patients for whom a rescue analgesia was necessary in post anesthesia care unit and ambulatory surgery unit
时间窗: from arrival in post anesthesia care unit until discharge (An expected average of 4 hours after end of surgery)
次要结局
- Post operative pain (FLACC scale) at hospital(from recovery room until discharge (An expected average of 4 hours after end of surgery))
- Intraoperative opioid consumption : total Rémifentanil (µg/kg)(for time of surgery (1 to 4 hours))
- Plasmatique peak of levobupivacaine (Cmax in µg/ml)(5 min until 75 min after injection of local anaesthetic)
- Time necessary to reach plasmatique peak of levobupivacaine (tmax in min)(5 min until 75 min after injection of local anaesthetic)
- Complications related to local analgesia procedure(until 24 hours in post operative)
- First request of rescue antalgic (Nubain or Tramadol)(until 24 hours in post operative)
- Consommation of rescue antalgic(until 24 hours in post operative)
- Pain evaluation at home by parents (score PPMP)(call between 24 and 48 hours in post operative)