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Clinical Trials/NCT03361813
NCT03361813
Unknown
Not Applicable

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

Assiut University1 site in 1 country60 target enrollmentDecember 10, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain Management
Sponsor
Assiut University
Enrollment
60
Locations
1
Primary Endpoint
Surgical field (intra-operative reactionary bleeding and/or muscle tear)
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 10, 2017
End Date
February 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed H Othman

Assisstant professor of Anesthesia ICU and pain Relief

Assiut University

Eligibility Criteria

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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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 Frame: 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)

Study Sites (1)

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