跳至主要内容
临床试验/CTRI/2012/01/002387
CTRI/2012/01/002387招募中不适用

Comparison of Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block For Pain Relief In Children Undergoing Lower Abdominal Surgery

Department of Anaesthesiology Pain and Perioperative Medicine1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年2月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
1.Duration of postoperative analgesia: It will be defined as the time interval beginning from the end of anaesthesia to the time the child has a FLACC score 3

研究概览

简要总结

Caudal epidural block is the most commonly performed regional block in paediatric anaesthesia for providing intraoperative and postoperative analgesia after lower abdominal and perineal surgeries. Although the efficacy and safety of this technique is high, it has certain disadvantages such as unwarranted motor blockade of the lower limbs and disturbance of bladder function.The limitation of caudal block when administered  as a ‘single- shot technique’ is its limited duration of action, about 4-6 hours post block, making administration of additional pain medicine necessary.

Peripheral nerve blocks are alternative to caudal block with a lower incidence of side effects and a prolonged duration of analgesia. The nerves that supply the abdominal wall (T7-L1) course through the neurofascial plane between the internal oblique and the transversus abdominis muscle. The blockade of nerves in this location is known as the transversus abdominis plane block (TAP block). Ultrasound guided technique improves the margin of safety due to better localization and deposition of local anaesthetic with improved accuracy. Ultrasound guided transversus abdominis plane (TAP) block has been described in children undergoing lower abdominal and laparoscopic surgery. However, there are only few randomized clinical trials regarding use of ultrasound guided TAP block in children.

In the present study we want to compare the efficacy of ultrasound guided transversus abdominis plane (TAP) block and caudal block for providing postoperative pain relief in children undergoing lower abdominal surgeries.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
2.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • 1.ASA physical status I or II 2.unilateral lower abdominal surgeries such as hernia repair, orchidopexy under general anaesthesia.

排除标准

  • 1.Children undergoing bilateral lower abdominal surgery.
  • 2.Children with known allergy to bupivacaine.
  • 3.Children undergoing additional surgical procedure at anatomical location not covered by either transversus abdominis plane block or caudal block.
  • 4.Children with history of renal or hepatic insufficiency.

结局指标

主要结局

1.Duration of postoperative analgesia: It will be defined as the time interval beginning from the end of anaesthesia to the time the child has a FLACC score 3

时间窗: From begining of anaesthesia till first 24 hours postoperatively

次要结局

  • 1.Quality of pain relief in the first 24 hours postoperatively evaluated using the FLACC scale.(2.Amount of rescue analgesia administered.)

研究者

发起方
Department of Anaesthesiology Pain and Perioperative Medicine
申办方类型
Research institution and hospital

研究点 (1)

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