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临床试验/CTRI/2017/06/008729
CTRI/2017/06/008729已完成不适用

Randomised prospective study of comparison of ultrasound guided transversus abdominis plane (TAP) block versus local infiltration during paediatric laparoscopic surgeries

Department of Anaesthesia Seth GS medical college and KEM hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2017年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
Pain relief

研究概览

简要总结

SUMMARY

Althoughabdominal laparoscopic surgery is known for less pain compared to that oflaparotomy, many patients actually still complain of considerable postoperativepain. Pain after laparoscopic surgeries is caused by the incision andvisceroperitoneal pain due to peritoneal stretch and inflammation. A promisingapproach to the provision of postoperative analgesia after abdominal surgery isto block the sensory nerve supply to the anterior abdominal wall by placing alocal anaesthetic in the transversus abdominis plane. The TAP block was firstdescribed by McDonell and colleagues in 2004 and a USG guided technique wassubsequently described by Hebbard and colleagues. USG guided TAP block providesexcellent pain relief in lower abdominal surgeries. The purpose of this studyis to evaluate the analgesic efficacy of USG guided TAP block in childrenundergoing laparoscopic surgeries.

Afterobtaining ethical clearance from the institutional review board, the study willbe carried out in 72 patients posted for laparoscopic surgeries like herniarepair, orchidopexy, appendicectomy and cholecystectomy in Paediatric SurgeryOT. The patients will be divided into two groups after induction ofanaesthesia:

Group A: Patients will receive bilateral TAP block under USGguidance using 0.4ml/kg 0.25% Inj. Bupivacaine.

Group B: Patients will receive local infiltration at the portusing 0.4ml/kg 0.25% Inj. Bupivacaine.

Inj Paracetamol 15mg/kg will be given intravenously in bothgroups at the beginning of surgery. Parameters recorded will be: Intraoperativelyhemodynamics i.e. heart rate and blood pressure monitoring every 15minutes andtotal dose of opioid required. Postoperatively assessment of pain: Wong BakerFACES scale, duration of analgesia and adverse effects. Thepain score will be assessed at 10min, 30mins, 1hour and hourly thereafter up to6 hours post operatively.Inj. Diclofenac 1.5mg/kg will be given as rescue analgesic post operatively ifthe Wong Baker’s FACES score is more than 4.

Statistical analysis: Statistical analysis of thedemographic data will be done using Chi-square test. The continuous outcomeswill be measured using the Student’s t test or the Mann Whitney U test. A pvalue<0.05 will be considered significant.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant and Investigator Blinded

入排标准

年龄范围
2.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • •1.ASA I and II patients posted for elective laparoscopic surgeries in Paediatric surgery OT 2.Age between 2-12 years of both sexes 3.Children undergoing laparoscopic appendicectomy, hernia repair, cholecystectomy, and orchidopexy.

排除标准

  • •1.Refusal by the parent to participate in the study 2.Children in whom TAP block is contraindicated i.e. surgical scar or distorted anatomy at the site of injection.
  • •3.Children with known allergy to local anaesthetics.
  • •4.Children with known cardiovascular, respiratory, hepatic or renal disease 5.Laparoscopy converted to open surgery.

结局指标

主要结局

Pain relief

时间窗: The pain score will be assessed at 10min, 30mins, 1hour and hourly thereafter up to 6 hours post operatively

次要结局

  • Opioid Requirement(intraoperatively)
  • Intraoperative Hemodynamics(at 5, 15, 30, 45 and 60 mins Intraoperatively)

研究者

发起方
Department of Anaesthesia Seth GS medical college and KEM hospital
申办方类型
Government medical college

研究点 (1)

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