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临床试验/NCT04208165
NCT04208165已完成不适用

Ultrasound Guided Paravertebral Block Versus Transverse Abdominis Plane Block in Hepatic Patients Undergoing Laparoscopic Cholecystectomy

Theodor Bilharz Research Institute2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年12月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Postoperative pain score

研究概览

简要总结

The Era of using ultrasound guided blocks provides an attractive and more or less safe alternative to other techniques. Among these blocks is ultrasound-guided transverse abdominis plane block (USG-TAP block) that controls pain by local anesthetic injection into the neurofascial plane of the abdominal muscles. Ultrasound-guided thoracic paravertebral block (USG-TPVB) is another technique in which local anesthetic is injected nearby the thoracic vertebra where spinal nerve emerges from the intervertebral foramina. It provides ipsilateral somatic and sympathetic blockade in many dermatomes around the injection site. The aim of this study is to verify which technique is more efficient in reducing the intra- and postoperative analgesic requirements in hepatic patients.

详细描述

Study design:

Prospective randomized clinical study, sixty patients will be randomly allocated to one of two groups according to a computer-generated random number table of 30 patients each to receive ultrasound-guided either TAP block (Group T) or PVB (Group P).

Study setting and location Theodor Bilharz research institute.

Study population:

60 patients (ASA II or III ) undergoing laparoscopic cholecystectomy under general anesthesia will be recruited and will be randomly allocated using a computer-generated random number table of 30 patients each to receive either:

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
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective laparoscopic cholecystectomy surgery.
  • Age: adult patients between 20 - 65 years old.
  • Gender: Both male and female.
  • ASA Class: II.
  • hepatic patients child A or B

排除标准

  • Refusal of patient.
  • Pregnancy and lactation.
  • Fever or sepsis.
  • Patients ASA class III and IV.
  • Child C hepatic patients
  • Addicts and drug abusers.
  • Patients taking corticosteroids or any cardio - active drugs.
  • Local infection at site of the injection.
  • Allergy to any of the study medications.
  • Severe coagulopathy
  • kyphoscliosis concerning the paravertebral group will be excluded from the study.

结局指标

主要结局

Postoperative pain score

时间窗: 2 hours after surgery.

Postoperative pain will be estimated by a numeric rating scale (NRS) (0 = no pain, 10 = worst imaginable pain) on coughing.

次要结局

  • Intra-operative fentanyl (analgesic) consumption(During the operation)
  • Total desflurane (anesthetic) consumption(From start of desflurane application til the end of surgery.)
  • Postoperative pethidine (analgesic) consumption(24 hours after operation)

研究者

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

Hanan Farouk Khafagy

Professor doctor

Theodor Bilharz Research Institute

研究点 (2)

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