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临床试验/NCT06839391
NCT06839391尚未招募1 期

Effect of Hyaluronidase in Different Doses Added to Bupivacaine on TAB Block Quality During CS

Benha University0 个研究点目标入组 120 人开始时间: 2025年3月最近更新:
干预措施
相关药物

试验速览

阶段
1 期
状态
尚未招募
入组人数
120
主要终点
visual analogue scale

研究概览

简要总结

evaluate the efficacy of hyaluronidase in different doses as an adjuvant to bupivacaine in ultrasound-guided TAB block during CS

详细描述

Hyaluronidase acts by catalyzing the hydrolysis of hyaluronan, decreased its viscosity, and enchasing the tissue permeability. So, this makes it a suitable additive for other drugs to speed up their distribution and delivery especially in ophthalmic surgery. Several studies showed that multiple injection techniques of TAB block were more successful with a faster onset of anesthesia and higher success rates, with a change in the incidence of complications.

This double-blinded randomized prospective study was conducted to evaluate the efficacy of hyaluronidase in different doses as an adjuvant to bupivacaine in ultrasound-guided TAB block during CS . The primary outcome of this study was the duration of sensory block, while secondary outcomes included the onset of sensory block, success rate, total doses of intraoperative rescue analgesia, number of patients needed for postoperative rescue analgesia, and complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant 20-45 y medical free

排除标准

  • • Hepatic.
  • Diabetic.
  • Hypertensive.
  • Cardiovascular dysfunction.

研究组 & 干预措施

group I

Experimental

After skin closure, they got TAB block with 20 cc of 0.25 percent bupivacaine on each side without any adjuvant.

干预措施: Hyaluronidase (Drug)

group II

Experimental

obtained After the skin was closed, we received TAB block with 20 ml of 0.25% bupivacaine and 5 ml of 0.9% normal saline containing 500 IU (100 IU/ml) of hyaluronidase (Hynidase) as an adjuvant on each side.

干预措施: Hyaluronidase (Drug)

GROUP III

Experimental

obtained After the skin was closed, we received TAB block with 20 ml of 0.25% bupivacaine and 5 ml of 0.9% normal saline containing 1000 IU (200 IU/ml) hyaluronidase (Hynidase) as an adjuvant on each side.

干预措施: Hyaluronidase (Drug)

结局指标

主要结局

visual analogue scale

时间窗: 2-6-10-16-24 hours postoperatively

postoperatively pain assesment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed said MOSTAFA elmeligy

anesthesia lecturer

Benha University

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