Pre-emptive Trans-cutaneous Versus Trans-oral Ultrasound Guided Peritonsillar Infiltration With Bupivacaine During Tonsillectomy

Not Applicable

• Conditions: Postoperative Pain Management
• Interventions: Other: trans-oral ultrasound guided peritonsillar infiltration; Other: trans-cutaneous ultrasound guided peritonsillar infiltration

• Registration Number: NCT03361813
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-19
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-01
• Study First Posted: 2017-12-05
• Last Update Submitted: 2017-12-09
• Study Start: 2017-12-10
• Last Update Posted: 2017-12-12
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
trans-cutaneous ultrasound guided peritonsillar infiltration	trans-oral ultrasound guided peritonsillar infiltration	-
trans-oral ultrasound guided peritonsillar infiltration	trans-cutaneous ultrasound guided peritonsillar infiltration	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Al-Azhar University Hospital; 🇪🇬 Cairo, Egypt