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临床试验/CTRI/2024/10/075655
CTRI/2024/10/075655尚未招募不适用

The effectiveness of transverse abdominis plane (tap) block in reducing the need for postop analgesics after c-section under spinal anesthesia: a randomised control trial

Al Azhar Medical College and Super Speciality Hospital1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
44
试验地点
1
主要终点
Reduction in the amount of analgesic requirement after cesarean section

研究概览

简要总结

A significant number of women who have caesarean section experiences moderate-to-severe postoperative pain especially around 6 hours after delivery. Transversus abdominis plane (TAP) block is a regional anesthesia technique in which a local anesthetic is injected into the transversus abdominis (TA) planeAim of the study is to determine the effectiveness of transverse abdominis plane (tap) block in reducing the amount of analgesics required during the first 48 hours after c-section under spinal anesthesia.

Investigator and patient blinded randomized control trial. The sample size for the present study was calculated to be 44. All eligible patients undergoing caesarean section delivery under spinal anaesthesia at will be included after taking informed consent.Patients will be classified into two groups using block randomization.

Group A :  TAP block will be done using USG guidance.  Postoperative analgesia will be provided with IV DICLOFENAC( 50 mg IV) q8h and PARACETAMOL 1000  mg q8h. Rescue doses with analgesics will be allowed (TRAMADOL 50 mg) when VAS score is >4

Group B: Standard systemic intravenous postoperative analgesia IV DICLOFENAC( 50 mg IV) q8h and PARACETAMOL 1000  mg q8h will be given. Rescue doses with analgesics will be allowed (TRAMADOL 50 mg) when VAS score is >4.

Result values will be recorded using a proforma. Visual analogue scale needs to be recorded immediately on shifting to recovery and then at 2hr, 6 hr, 12 hr, 24 hr, and 48 hr both at rest and during voluntary contraction of abdominal muscles. Time at which first rescue analgesic is given to be noted. Requirement of rescue analgesics in the first 48 hrs postoperatively and presence of PONV and drowsiness is also assessed.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
19.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • ASA physical status II Term pregnancies of Gestational age between 37 to 42 weeks, with a singleton foetus undergoing caesarean section delivery done under spinal anaesthesia.

排除标准

  • Body mass index more than 35 anatomic conditions that may preclude the regional block.

结局指标

主要结局

Reduction in the amount of analgesic requirement after cesarean section

时间窗: 48 hours after cesarean section

次要结局

  • Patient satisfaction with anaesthesia among both the groups(48 hours after cesarean section)

研究者

发起方
Al Azhar Medical College and Super Speciality Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Mathew George

Al Azhar Medical College and Super Speciality Hospital

研究点 (1)

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