跳至主要内容
临床试验/NCT03361813
NCT03361813Unknown不适用

Comparative Study Between Pre-emptive Trans-cutaneous Versus Trans-oral Ultrasound Guided Peritonsillar Space Infiltration With Bupivacaine During Elective Tonsillectomy

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年12月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Surgical field (intra-operative reactionary bleeding and/or muscle tear)

研究概览

简要总结

Ultrasound as a technique is safe, readily available, quick and portable allowing more accuracy of different regional blocks and local infiltration. It allows imaging of the mouth, oropharynx, infrahyoid structures, larynx, vocal cords, and trachea. Recently, ultrasound has been shown to improve accuracy in ultrasound guided block with local anesthetic infiltration. The objective of our study is to compare the effect of pre-emptive trans-oral ultrasound guided peritonsillar infiltration versus trans-cutaneous ultrasound (US) guided peritonsillar infiltration with bupivacaine for post-tonsillectomy analgesia, on surgical field, and surgeon satisfaction(intra-operative reactionary bleeding).

Materials and Methods: the patients will be admitted for tonsillectomy at ENT department of the Al- Azhar university hospitals. The patients' ages between 3 to 15 years. Patients will be divided into Cutaneous group: patients will be submitted to Trans-cutaneous ultrasound guided peritonsillar infiltration with bupivacaine, and Oral group: patients will be submitted to Trans-oral ultrasound guided peritonsillar infiltration with bupivacaine.

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 (Participant, Care Provider)

入排标准

年龄范围
3 Years 至 15 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •ASA (American Society of Anesthesiologists) physical status I-II with no airway complications or systemic diseases or known psychological diseases. Reason for their surgery was recurrent or chronic tonsillitis.

排除标准

  • •Infection at the site of injection, peritonsillar abscess or cellulites.

研究组 & 干预措施

trans-cutaneous ultrasound guided peritonsillar infiltration

Active Comparator

干预措施: trans-oral ultrasound guided peritonsillar infiltration (Other)

trans-oral ultrasound guided peritonsillar infiltration

Placebo Comparator

干预措施: trans-cutaneous ultrasound guided peritonsillar infiltration (Other)

结局指标

主要结局

Surgical field (intra-operative reactionary bleeding and/or muscle tear)

时间窗: time of surgery

* Iintra-operative reactionary bleeding and/or muscle tear assessment by number of soaked gauze per 20 min (per tonsil) (3 soaked gauze per 20 min (per tonsil) = no reactionary bleeding (0 point), 6 soaked gauze per 20 min (per tonsil) = mild bleeding (1 point) and 10 soaked gauze or more per 20 min (per tonsil) = moderate to severe bleeding (2 points). * Dissection time assessment (dissection time 10 min or less per tonsil = no bleeding (0 point), dissection time 20 min per tonsil = mild bleeding (1 point) and dissection time 30 min or more per tonsil = moderate to severe bleeding (2 points).

Surgeon satisfaction

时间窗: time of surgery

Direct surgeon questionnaire assessment about bleeding and surgical field (full satisfaction= no bleeding (0 point), fair satisfaction= mild bleeding (1point), and poor satisfaction= moderate to severe bleeding (2 points)

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

Ahmed H Othman

Assisstant professor of Anesthesia ICU and pain Relief

Assiut University

研究点 (1)

Loading locations...

相似试验