跳至主要内容
临床试验/CTRI/2021/05/033512
CTRI/2021/05/033512尚未招募不适用

Analgesic effectiveness of surgically administered transversus abdominis plane block versus conventional transversus abdominis plane block in elective caesarean sections – an open labelled randomised control trial.

Bangalore Baptist Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年5月14日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Time to rescue analgesia

研究概览

简要总结

Caesarean section delivery is becoming morefrequent and at present is one of the most common major operative proceduresperformed worldwide. It is important that effectivepostoperative analgesia is provided to facilitate early ambulation, infant care(which also includes breast feeding, mother infant bonding) and prevention ofpostoperative morbidity. Therefore, the analgesic regimen needs to meet thegoals of providing safe and effective analgesia with minimal side effects forthe mother and the neonate. TAP block as a part of multimodal analgesic regimenwould result in decreased opioid and NSAID consumption and improved analgesia.TAP block is conventionally performed by the anaesthesiologist, using apercutaneous approach under ultrasound-guidance. The surgically administeredTAP block is a variant of TAP block administration, the efficacy of which incomparison to the conventional TAP block as a part of multimodal analgesicregimen following caesarean section is not very widely studied till date. Ourstudy is designed to assess if the newly described surgical TAP block is aseffective as the conventional TAP block (by comparing the requirement of rescueanalgesia in both the groups) for post-operative analgesia following caesareansection in the Indian set-up in which surgical TAP block prove to be an easierprocedure as there no the need for skilled operators or specialized equipment.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • •Pregnant women undergoing elective caesarean section under spinal anaesthesia
  • •Age group of 18-40 years.
  • •ASA grade I or II.

排除标准

  • •Patient refusal
  • •If vertical abdominal incision was required
  • •Planned duration of surgery more than two hours
  • •Having blood loss greater than 2 L
  • •Thrombocytopenia
  • •History of allergy to the study drug
  • •Body Mass Index (BMI) <18 or >35 Kg/m2
  • •Patients with hypertensive disorders
  • •Alcohol or drug abuse.

结局指标

主要结局

Time to rescue analgesia

时间窗: Before 24 hours

次要结局

  • Amount of rescue analgesia(Before 24 hours)
  • •Time taken to perform the TAP block(AT THE TIME OF PROCEDURE)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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