跳至主要内容
临床试验/NCT02753361
NCT02753361已完成不适用

Ultrasound-Guided Regional Blockade for Lipoma Excision: a New Approach to an Old Technique

Suez Canal University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
The number of needle attempts needed to complete the block placement. New attempt will be defined as needle reinsertions through separate skin puncture.

研究概览

简要总结

There is limited information on using the ultrasonography for block placement concerning lipoma excision. A new type of regional blockade, performed under ultrasound, can ensure proper block placement with accurate local anesthetics deposition. Investigators hypothesized that ultrasound guidance can reduce the number of needle passes to complete the block placement. Investigators will compare namely ultrasound guided regional blockade and traditional method regarding the number of needle passes to complete the block placement.

详细描述

50 patients between the ages of 18 and 60 years with American Society of Anesthesiologists (ASA) physical status I-III, scheduled for superficial subcutaneous lipoma (sized from 5 to 7 cm) excision will be enrolled in prospective comparative randomized clinical study.

Patients will be randomized into two groups: U (n = 25), in whom regional blockade was performed using US-guidance; and C (n = 25), in whom regional block was performed using the traditional method. Patients will be randomly assigned on a one-to-one ratio. Randomization will be performed by means of a computer generated random-numbers table. Group allocation will be concealed in sealed opaque envelopes that will not opened until patient consent had been obtained.

All patients will be pre-medicated with oral diazepam (7.5 mg) 30 min before the procedure, and IV fentanyl (50 ug) will be administered 5 minutes before placement of the block. Before the procedure, an IV access and standard monitoring of electrocardiogram (ECG), noninvasive blood pressure (NIBP), and peripheral oxygen saturation (SPO2) will be established.

Primary outcome includes the number of needle attempts (number of skin punctures and needle redirections) needed to complete the block placement. It will be documented by an investigator blinded to the aim of the study. Patient demographics, duration of surgery, patient's ASA physical status and other study outcomes will be documented by independent investigators who were not involved in the block placement procedure and were blinded to the group assignment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between the ages of 18 and 60 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Superficial subcutaneous lipoma excision surgery (sized from 5 to 7 cm)
  • Able to provide informed consent
  • Consent to participates
  • Single procedure

排除标准

  • Unable to consent
  • Do not consent to participate
  • Patients with local infections in the skin over lipoma
  • Patients with history of allergy to local anesthetics
  • More than one procedure is being performed at the same setting

研究组 & 干预措施

Traditional

No Intervention

This will utilize the traditional method of performance of regional block

US-guided

Experimental

In this arm, regional block will be performed under the ultrasound guidance

干预措施: Ultrasound guidance (Procedure)

结局指标

主要结局

The number of needle attempts needed to complete the block placement. New attempt will be defined as needle reinsertions through separate skin puncture.

时间窗: 10 - 20 minutes

次要结局

  • The incidence of adverse events(8 hours postoperatively)
  • The block success rate(20 minutes)

研究者

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

Tarek F.Tammam

Tarek F.Tammam, M.D., Ph.D, Department of Anesthesia and Intensive Care, Faculty of Medicine, Suez Canal University Hospital, Egypt

Suez Canal University

研究点 (2)

Loading locations...

相似试验